Malaria Rapid Diagnostic

Test Performance
Results of WHO product testing of
malaria RDTs: round 7 (2015–2016)
Malaria Rapid Diagnostic
Test Performance
Results of WHO product testing of
malaria RDTs: round 7 (2015–2016)
 Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 7 (2015-2016)
ISBN 978-92-4-151268-8
© World Health Organization 2017
Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO;
https://creativecommons.org/licenses/by-nc-sa/3.0/igo).
Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as
indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO
logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation
of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization
(WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”.
Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property
Organization.
Suggested citation. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 7 (2015-2016). Geneva: World Health
Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.
Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris.
Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights
and licensing, see http://www.who.int/about/licensing.
Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility
to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of
any third-party-owned component in the work rests solely with the user.
General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever
on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or
boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.
The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to
others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed
without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall
WHO be liable for damages arising from its use.
Printed in [add country – for customs purposes]
Layout: Bruno Duret
Editor: Elisabeth Heseltine

WHO does not warrant that: (1) the lists and figures are complete and/or error free and/or that (2) any products mentioned in the figures
and tables are of acceptable quality, have obtained regulatory approval in any country or that their use is otherwise in accordance with
the national laws and regulations of any country, including patent laws. Mention of any product in this report, particularly in any of the
figures and tables on pp. 8 and 9, does not imply their approval by WHO (as this is the sole prerogative of national authorities).
The WHO Programme of Prequalification of Diagnostics and Medical Devices uses the results of the WHO Malaria RDT Product Testing
Programme as the laboratory evaluation component of the prequalification process for malaria RDTs. Although WHO prequalification is not
currently a requirement for WHO procurement, manufacturers are encouraged to apply for it. A regularly updated list of WHO-prequalified
diagnostics, including malaria RDTs, is available at http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/.
WHO recommendations for procurement of malaria RDTs are currently based on the attainment of a set of minimum performance
criteria in the WHO Malaria RDT Product Testing Programme. The recommendations were established by the WHO Malaria Policy Advisory
Committee in 2012, are outlined in this report and are presented in full in a WHO information note (available at http://www.who.int/
malaria/publications/atoz/rdt-selection-criteria.pdf ). Products that do not meet the full set of minimum performance criteria are not
eligible for procurement by WHO. As of 1 January 2018, WHO prequalification will become a requirement for procurement recommendation
(http://www.who.int/malaria/news/2016/rdt-procurement-criteria/en/ ).
The lists of RDTs included in this report are not exhaustive but reflect those products that were submitted for evaluation in rounds 4–7
of the WHO Malaria RDT Product Testing Programme. Their mention indicates the extent to which these products, as manufactured by
the listed companies, were – at the time of their evaluation – found to meet the above-mentioned set of minimum performance criteria.
The evaluations indicated in the figures and tables apply only to the specific product listed with its unique product code or catalogue
number and as manufactured by the listed company.
Improper storage, transport or handling of malaria RDTs may affect their performance.
The fact that certain products are not included in any of the lists and figures in this report indicates that they have not or not yet been
submitted for evaluation to the WHO Malaria RDT Product Testing Programme or that their evaluation has not yet been completed and
published or that they have been removed from summary reports due to noncompliance with compulsory resubmission requirements.
It does not indicate anything in respect of such products’ performance. The lists and figures are updated regularly, and malaria RDTs are
added to the lists and figures as and when (following voluntary participation in the WHO Malaria RDT Product Testing Programme) their
evaluation against the above-mentioned set of minimum performance criteria has been completed.
Although the malaria RDTs listed in the tables and figures are regularly re-evaluated, and updated evaluations are published by WHO, WHO
cannot ensure that products on the lists and in figures will continue to meet the performance criteria in the same manner as indicated.
WHO recommends therefore that, before procuring a malaria RDT, each lot of that product be tested at one of the two following lot-testing
laboratories: the Institut Pasteur du Cambodge, Cambodia, or the Research Institute for Tropical Medicine, Philippines.
WHO disclaims any and all liability and responsibility whatsoever for any injury, death, loss, damage or other prejudice of any kind that
may arise as a result of or in connection with the procurement, distribution and use of any product included in this report and the figures
and tables listed on pages V-VIII.
This report may not be used by manufacturers and suppliers for commercial or promotional purposes.

II
 Acknowledgements IX

Contents
Abbreviations X
1. Summary of performance of rapid
diagnostic tests for malaria: WHO product
testing rounds 1–7 1
1.1. Introduction 1
1.2. The WHO product testing programme 1
1.3. Panel detection score and other results of the evaluation 2
1.4. Summary of outcomes 4
1.5. De-listing of products in summary report 5
1.6. How product testing results can inform RDT procurement
and use 5
1.7. Product testing and WHO programme for prequalification
of diagnostics and medical devices 6
2. Executive summary 21
2.1. Introduction 21
2.2. The WHO product testing programme 21
2.3. Results of the evaluation 22
2.4. Use of the results 23
3. Background 24
4. Objective 24
5. Materials and methods 26
5.1. Test selection 26
5.2. The product testing protocol 28
5.3. Evaluation panels 28
5.4. Product registration 30
5.5. Specimen panel registration 30
5.6. Test phases 30
5.7. Performing rapid tests 32
5.8. Interpreting the results 32
5.9. Recording anomalies 32
6. Data management 32
7.  Quality assurance 33
7.1. Quality of malaria RDTs and their use 33
7.2. Quality and objectivity of RDT readings 33
7.3. Quality of WHO specimen bank samples 33
7.4. Quality of the product testing site 33
8. Ethical considerations 33
9. Data analysis 34
9.1. Measures of parasite detection: panel detection score
and positivity rates 34
9.2. False-positive results 34
9.2.1  Incorrect species identification 34
9.2.2 False-positive results for Plasmodium-negative samples 34
9.3. Band intensity 34
9.4. Lot agreement 35
9.5. Invalid tests 35
9.6. Heat (thermal) stability 35
9.7. Anomalies 35
9.8. Labelling and instructions for use 35

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) III
 10. ASSOCIATION BETWEEN PARASITE DENSITY
AND ANTIGEN CONCENTRATION 36
11. evaluation of malaria rapid diagnostic
tests in the Laboratory and in the field 36
12. Results 37
12.1. Summary 37
12.2. Phase 1: P. falciparum culture panel 43
12.3. Phase 2: wild -type P. falciparum and P. vivax- and
Plasmodium spp.-negative samples. 43
12.3.1  P. falciparum detection 43
12.3.2  P. vivax detection 44
12.3.3 Combined detection of P. falciparum and P. vivax 45
12.3.4  P. falciparum and P. vivax positivity rate 45
12.3.5 Band intensity 45
12.3.6 False-positive rates 47
12.4. Performance of resubmitted products 50
13.  Heat stability 52
13.1. Summary 52
13.2. Plasmodium falciparum 52
13.3. Plasmodium vivax 52
14. Ease of use, anomalies, Labelling and
instructions for use 60
14.1. Ease of use 60
14.2. Anomalies 60
14.3. Labelling and instructions for use 60
15. Discussion of key findings 73
15.1. Panel detection score and its relation to sensitivity 73
15.2. False-positive rate and specificity 74
15.3. Reactivity of combination HRP2 and pan-pLDH test lines
against P. falciparum samples 74
15.4. Heat (thermal) stability 75
15.5. Ease-of-use description 75
15.6. Labelling and instructions for use 75
15.7. Anomalies in RDT production lots 76
15.8. Inter-lot variation 76
15.9. Selecting RDTs: target antigens, species and sensitivity 76
16. USING RESULTS TO ENSURE HIGH-QUALITY
DIAGNOSIS IN THE FIELD 78
16.1. WHO prequalification 78
16.2. Beyond procurement 78
16.3. Post-market surveillance: lot verification 79
17. Conclusions 79
18. References 80
Annexes 83
Annex S1: Characteristics of evaluation panels used in rounds 1–7
of WHO malaria RDT product testing, 2008–2016 84
Annex S2: Malaria RDT field assessment and anomalies 87
Annex S3: Selection of an appropriate RDT 90
Annex 1: Characteristics of RDTs evaluated in round 7 91
Annex 2: Malaria RDTs: guide to interpretation of results 93
Annex 3: Phase-1 results 108
Annex 4: Phase-2 results 112
Annex 5: Introducing RDT-based malaria diagnosis
into national programmes 145

IV Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
figures

Figure S1. Malaria RDT performance in phase 2 of rounds 4–7 against wild-type (clinical) samples containing P. falciparum
at low (200) and high (2000) parasite density (parasites/µL) and clean-negative samples
Figure S2. Malaria RDT performance in phase 2 of rounds 4–7 against wild-type (clinical) samples containing P. vivax
at low (200) and high (2000) parasite density (parasites/µL) and clean-negative samples
Figure S3. Panel detection score of malaria combination RDTs meeting WHO procurement criteria for false-positive
and invalid rates, in phase 2 of rounds 4–7 against wild-type (clinical) samples containing P. falciparum and
P. vivax at low parasite density (200 parasites/µL)
Figure 1. Mode of action of antigen-detecting malaria RDTs
Figure 2. Network of specimen collection, characterization and testing sites
Figure 3. Overview of malaria RDT product testing
Figure 4a. Origin of phase-2 P. falciparum wild-type (clinical) samples
Figure 4b. Origin of phase-2 P. vivax wild-type (clinical) samples
Figure 5. Testing procedure and calculation of panel detection score and band intensity for product A against a sample
density of 200 parasites/µL
Figure 6. Testing procedure and calculation of panel detection score and band intensity for product A against a sample
density of 2000 parasites/µL
Figure 7. Classification of incorrect species identification with combination malaria RDTs
Figure 8. Explanation of lot agreement calculation
Figure 9. Phase-1 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/µL)
Figure 10. Phase-2 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/µL)
Figure 11. Phase-2 P. vivax panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/µL)
Figure 12. Phase-2 P. falciparum panel detection score and positivity rate at 200 parasites/µL
Figure 13. Phase-2 P. vivax panel detection score and positivity rate at 200 parasites/µL
Figure 14. Phase-2 P. falciparum (P. falciparum test line) false-positive rate against clean-negative samples
Figure 15. Phase-2 Plasmodium spp. (pan or P. vivax test line) false-positive rate against clean-negative samples
Figure 16. Phase-2 P. falciparum false-positive rate versus P. falciparum panel detection score at low parasite density
(200 parasites/µL)
Figure 17. Phase-2 P. vivax false-positive rate versus P. vivax panel detection score at low parasite density (200 parasites/µL)
Figure 18. Phase-2 P. falciparum panel detection score at low parasite density (200 parasites/µL) during initial and
subsequent testing of compulsorily and voluntarily resubmitted malaria RDTs
Figure 19. Phase-2 P. vivax panel detection score at low parasite density (200 parasites/µL) during initial and subsequent
testing of compulsorily and voluntarily resubmitted malaria RDTs
Figure 20. Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a low-density P. falciparum
sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation
Figure 21. Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a high-density P. falciparum
sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation
Figure 22. Heat stability of P. falciparum-specific test line in combination tests against a low-density P. falciparum
sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation
Figure 23. Heat stability of P. falciparum-specific test line in combination tests against a high-density P. falciparum
sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation
Figure 24. Heat stability of pan line of combination tests against a low-density P. falciparum sample (200 parasites/µL).
Positivity rate at baseline and after 60 days’ incubation
Figure 25. Heat stability of pan line of combination tests against a high-density P. falciparum sample (2000 parasites/µL).
Positivity rate at baseline and after 60 days’ incubation

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) V
 Figure 26. Heat stability of pan line of combination tests against a low-density P. vivax sample (200 parasites/µL).
Positivity rate at baseline and after 60 days’ incubation
Figure 27. Heat stability of pan line of combination tests against a high-density P. vivax sample (2000 parasites/µL).
Positivity rate at baseline and after 60 days’ incubation
Figure 28. Heat stability of P. vivax-specific test line in combination tests against a low-density P. vivax sample
(200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation
Figure 29. Heat stability of P. vivax-specific test line in combination tests against a high-density P. vivax sample
(2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation
Figure 30. Percentage of RDTs with various anomalies observed in production lots
Figure 31. Adherence to box labelling recommendations
Figure 32. Adherence to cassette labelling recommendations
Figure 33. Adherence to buffer bottle labelling recommendations
Figure 34. Accessory labelling – use of internationally recognized symbols
Figure 35. Completeness of information on accessory packaging – transfer device and lancet
Figure 36. Completeness of information on accessory packaging – dessicant and alcohol swab
Figure 37. Completeness of information included in the instructions for use: product information and intended use,
precautions and limitations
Figure 38. Completeness of information included in the instructions for use: procedure and performance specifications
Figure AS1.1. Box-and-whisker plot of distribution of P. falciparum HRP2 concentration (ng/mL) in product testing phase 2
(wild-type) panels
Figure AS1.2. Box-and-whisker plot of distribution of P. falciparum pLDH concentration (ng/mL) in product testing phase 2
(wild-type) panels
Figure AS1.3. Box-and-whisker plot of distribution of P. vivax pLDH concentration (ng/mL) in product testing phase 2
(wild-type) panels
Figure AS1.4. Box-and-whisker plot of distribution of P. falciparum aldolase concentration (ng/mL) in product testing phase 2
(wild-type) panels
Figure AS1.5. Box-and-whisker plot of distribution of P. vivax aldolase concentration (ng/mL) in product testing phase 2
(wild-type) panels
Figure AS2.1. Malaria RDT anomalies encountered in production lots
Figure AS3.1. Selecting an appropriate RDT
Figure A5.1. Example of malaria RDT implementation steps and timeline
Figure A5.2. Components of the budget for a malaria diagnosis programme

VI Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Tables

Table S1. Product resubmissions: WHO malaria RDT product testing rounds 1–7
Table S2. Malaria RDT phase-2 performance in rounds 4–6 against wild-type (clinical) samples containing P. falciparum
and P. vivax at low (200) and high (2000) parasite density (parasites/µL) and clean-negative samples
Table S3. Malaria RDT rounds 4–7 heat stability results on a cultured P. falciparum sample at low (200) and high (2000)
parasite density (parasites/µL). Positivity rate at baseline (room temperature) and after 60 days incubation
at room temperature, 35°C and 45°C
Table S4. Products evaluated during rounds 1-7 that have been removed from summary results listings
Table 1a. Manufacturers and products accepted into round 7 of WHO malaria RDT product testing programme
Table 1b. Products due for compulsory resubmission in round 7
Table 2. Characteristics of Plasmodium spp.-negative samples
Table 3. Malaria antigen concentrations (ng/mL) in round 7 wild-type, low-density (200 parasites/µL) samples
Table 4. Summary of phase-1 performance of 45 malaria RDTs against 20 cultured P. falciparum lines at low (200)
and high (2000) parasite density (parasites/µL)
Table 5. Summary of phase-2 performance of 46 malaria RDTs against wild-type (clinical) P. falciparum and P. vivax
samples at low (200) and high (2000) parasite density (parasites/µL) and Plasmodium spp.-negative samples
Table 6a. Heat stability testing results for 46 malaria RDTs on a cultured P. falciparum sample at low (200) and high
(2000) parasite density (parasites/µL). Positivity rate at baseline (room temperature) and after 60 days
incubation at room temperature, 35°C and 45°C
Table 6b. Heat stability testing results for 27 malaria combination RDTs on a wild-type P. vivax sample at low (200)
and high (2000) parasite density (parasites/µL). Positivity rate at baseline (room temperature) and after 60
days incubation at room temperature, 35°C and 45°C
Table 7. Ease-of-use description of 46 malaria RDTs evaluated in round 7 of WHO malaria RDT product testing
Table 8. Percentage distribution of anomalies observed by product in phase 2
Table AS1.1. Statistics for P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.2. Statistics for P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.3. Statistics for P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Table AS1.4. Statistics for P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS1.5. Statistics for P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels
Table AS2.1. Field assessment of RDT packaging, safety and ease-of-use to guide product selection
Table A3.1. Lot variation in positive results against phase-1 P. falciparum culture samples at low (200) and high (2000)
parasite density (parasites/µL)
Table A3.2. Distribution of test band intensity scores (0–4) against phase-1 P. falciparum cultured parasites at low (200)
and high (2000) parasite density (parasites/µL)
Table A4.1. Lot variation in positive results against phase-2 wild-type P. falciparum and P. vivax samples at low (200)
and high (2000) parasite density (parasites/µL)
Table A4.2. Distribution of test band intensity (0–4) scores against phase-2 wild-type P. falciparum samples at low (200)
and high (2000) parasite density (parasites/µL)
Table A4.3. Distribution of pan/P. vivax test band intensity (0–4) scores for phase-2 wild-type P. vivax samples at low
(200) and high (2000) parasite density (parasites/µL)
Table A4.4. Phase-2 P. falciparum test line false-positive rates for wild-type P. vivax samples at low (200) and high (2000)
parasite density (parasites/µL)
Table A4.5. Phase-2 pan (or P. vivax) test line false-positive rate for non-P. falciparum infection on phase-2 wild-type
P. falciparum samples at low (200) and high (2000) parasite density (parasites/µL)
Table A4.6. Phase-2 false-positive rate for P. falciparum test line results on all malaria-negative samples
Table A4.7. Phase-2 false-positive rate for P. falciparum in samples containing non-malarial infectious pathogens

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) VII
 Table A4.8. Phase-2 false-positive rate for P. falciparum in samples containing potentially cross-reacting blood immu-
nological factors
Table A4.9. Phase-2 false-positive rate of pan or P. vivax test line results on all malaria-negative samples
Table A4.10. Heat stability testing results for P. falciparum test line on a P. falciparum sample at low parasite density
(200 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room
temperature, 35°C and 45°C
Table A4.10a. Heat stability testing results for pan test line of combination RDTs on a P. falciparum sample at low parasite
density (200 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at
room temperature, 35°C and 45°C
Table A4.11. Heat stability testing results for P. falciparum test line on a P. falciparum sample at high parasite density
(2000 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room
temperature, 35°C and 45°C
Table A4.11a. Heat stability testing results for pan test line of combination RDTs on a P. falciparum sample at high parasite
density (2000 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at
room temperature, 35°C and 45°C
Table A4.12. Heat stability testing results for P. falciparum test line on parasite-negative samples. Positivity rate at baseline
(room temperature) and after 60 days’ incubation at room temperature, 35°C and 45°C
Table A4.12a. Heat stability testing results for pan or P. vivax test line of combination RDTs on parasite-negative samples.
Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35°C
and 45°C
Table A4.13. Heat stability testing results for P. falciparum test line on P. vivax samples at low parasite density
(200 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room
temperature, 35°C and 45°C
Table A4.14. Heat stability testing results for P. falciparum test line on P. vivax samples at high parasite density
(2000 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room
temperature, 35°C and 45°C
Table A4.15. Heat stability testing results for P. vivax test line on P. falciparum samples at low parasite density
(200 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room
temperature, 35°C and 45°C
Table A4.16. Heat stability testing results for P. vivax test line on P. falciparum samples at high parasite density
(2000 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room
temperature, 35°C and 45°C
Table A4.17. Heat stability testing results for pan or P. vivax test line of combination tests on a P. vivax sample at low
parasite density (200 parasites/µl). Positivity rate at baseline (room temperature) and after 60 days’ incubation
at room temperature, 35°C and 45°C
Table A4.18. Heat stability testing results for pan or P. vivax test line of combination tests on a P. vivax sample at high
parasite density (2000 parasites/µl). Positivity rate at baseline (room temperature) and after 60 days’ incubation
at room temperature, 35°C and 45°C

VI II Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Acknowledgements

The evaluation reported here was a joint project of the WHO Global Malaria Programme, the Foundation for Innovative New
Diagnostics (FIND) and the United States Centers for Disease Control and Prevention (CDC) within the WHO-FIND Malaria RDT
Evaluation Programme. The project was financed by FIND through a grant from UNITAID. The project would not have been
possible without the cooperation and support of the specimen collection sites and specimen characterization laboratories
mentioned, and the authors acknowledge the technical advice from many malaria diagnostic manufacturers and developers.
This report of round 7 of WHO malaria RDT product testing was compiled by Jane Cunningham (WHO, Global Malaria
Programme, Switzerland), Michelle Gatton (Queensland University of Technology, University of Queensland, Australia), and
Kate Kolaczinski (WHO, consultant).

The malaria RDT evaluation programme of WHO and FIND are grateful to all those who contributed to the evaluation and
to the preparation of this report or previous versions:
Salim Abdullah Ifakara Health Research and Development Centre, United Republic of Tanzania
Yong Ah United States Centers for Disease Control and Prevention, National Center for Global Health, Division
of Malaria and Parasitic Diseases, United States of America
Michael Aidoo United States Centers for Disease Control and Prevention, National Center for Global Health, Division
of Malaria and Parasitic Diseases, United States of America
Frederic Ariey Institut Pasteur, Cambodia
John Barnwell United States Centers for Disease Control and Prevention, National Center for Global Health, Division
of Malaria and Parasitic Diseases, United States of America
David Bell Foundation for Innovative New Diagnostics, Switzerland1
Andrea Bosman WHO, Global Malaria Programme, Switzerland
Qin Cheng Army Malaria Institute, Australia
Peter Chiodini Hospital for Tropical Diseases, United Kingdom
Jane Cunningham WHO, Global Malaria Programme, Switzerland
Djibrine Djalle Institut Pasteur of Bangui, Central African Republic
Dany Doung Institut Pasteur, Cambodia
Babacar Faye Université Cheikh Anta Diop, Senegal
Dionicia Gamboa Universidad Peruana Cayetano Heredia Instituto de Medicina Tropical, Peru
Michelle Gatton Queensland University of Technology, Australia
Jeffrey Glenn United States Centers for Disease Control and Prevention, National Center for Global Health, Division
of Malaria and Parasitic Diseases, United States of America
Iveth Gonzalez Foundation for Innovative New Diagnostics, Switzerland
Sandra Incardona Foundation for Innovative New Diagnostics, Switzerland
Cara Kosack Médecins sans Frontières, Netherlands
Myat Phone Kyaw Department of Medical Research, Myanmar
Jennifer Luchavez Research Institute of Tropical Medicine, Philippines
Christian Luna Research Institute of Tropical Medicine, Philippines
James McCarthy Queensland Institute of Medical Research, University of Queensland, Australia
Didier Menard Institut Pasteur, Madagascar; Institut Pasteur, Cambodia
Rathana Meth Institut Pasteur, Cambodia
Claribel Murillo Centro Internacional de Entrenamiento e Investigaciones Médicas, Colombia
Sina Nhem Institut Pasteur, National Malaria Centre, Cambodia
Bernhards Ogutu Kenya Medical Research Institute, Kenya

1 Currently affiliated with Global Health Technologies Global Good Fund (Intellectual Ventures Lab), United States

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) IX
 Pamela Onyor Kenya Medical Research Institute, Kenya
Wellington Oyibo University of Lagos, Nigeria
Roxanne Rees-Channer Consultant, Foundation for Innovative New Diagnostics, Hospital for Tropical Diseases, United
Kingdom
Muth Sinuon National Malaria Centre, Cambodia
Johanna B. Sornillo Research Institute of Tropical Medicine, Philippines
Scott Wilson United States Centers for Disease Control and Prevention, National Center for Global Health, Division
of Malaria and Parasitic Diseases, United States of America

Abbreviations

CDC United States Centers for Disease Control and Prevention

ELISA enzyme-linked immunosorbent assay
FIND Foundation for Innovative New Diagnostics
HRP2 histidine-rich protein 2
ISO International Organization for Standardization
PCR polymerase chain reaction
PDS panel detection score
pLDH Plasmodium lactate dehydrogenase
RDT rapid diagnostic test (for the purposes of this report, immunochromatographic lateral flow devices
for the detection of malaria parasite antigens)
TDR Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP,
the World Bank and WHO

X Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 Summary Rounds 1-7
1. Summary of performance of
rapid diagnostic tests for malaria:
WHO product testing rounds 1–7

1.1. Introduction
WHO estimates that 3.2 billion people are at risk for malaria. procurement. As of 1 January 2018, WHO prequalification,
In 2015, there were an estimated 212 million new cases (with comprising a dossier and inspections of manufacturing
an uncertainty range of 148 million to 304 million) and an sites as well as a laboratory evaluation, will determine the
estimated 429 000 deaths (with an uncertainty range of eligibility of malaria RDTs for procurement. Therefore, all
235 000 to 639 000). Approximately 90% of these deaths manufacturers that submit products to Round 8 and future
occurred in sub-Saharan Africa and just over 70% were rounds will be required also to submit applications for WHO
of children under 5 years. Malaria remains endemic in 91 prequalification.
countries and territories and while parasite-based diagnosis
is increasing, national surveys between 2013 and 2015 RDT sales increased from 46 million in 2008 (before imple-
suggest approximately 31% of suspected malaria cases in mentation of the product testing programme) to 320 million
sub-Saharan Africa were not confirmed with a diagnostic in 2013 (according to manufacturer sales data). In 2014, the
test, resulting in over-use of antimalarial drugs and poor number of diagnostic tests provided (RDTs and microscopy
disease monitoring (1). combined) in Africa exceeded the total number of courses
of artemisinin-based combination therapy administered in
WHO recommends that malaria case management be based Africa for only the second time. Since 2013, decreasing RDT
on parasite diagnosis in all cases (2). The use of antigen- sales in Asia have led to an overall decrease in global sales
detecting rapid diagnostic tests (RDTs) is a vital part of this (270 million were sold globally in 2015); however, sales in
strategy, forming the basis for extending access to malaria Africa have continued to rise each year since 2008. By 2014,
diagnosis by providing parasite-based diagnosis in areas it was confirmed that all 91 countries with ongoing malaria
where good-quality microscopy cannot be maintained. The transmission had adopted the WHO policy of testing before
number of RDTs available and the scale of their use have administering treatment. Despite these achievements, a
increased rapidly over the past few years. However, limita- large number of cases remain undiagnosed, particularly in
tions of field trials and the heterogeneous nature of malaria the private sector, indicating that some gains are still to be
transmission have limited the availability of the good-quality made (1).
data on performance that national malaria programmes
require to make informed decisions on procurement and This summary presents an overview of the results of rounds
implementation, and it is difficult to extrapolate the results 4–7 of malaria RDT product testing and key concepts for
of field trials to different populations and times. Therefore, understanding and using the results. It is published in
in 2006, the WHO Special Programme for Research and conjunction with the release of the full report on round 7.
Training in Tropical Diseases (TDR) and the Foundation for With the exception of products that are no longer manu-
Innovative New Diagnostics (FIND) launched a programme factured and/or are de-listed because of failure to comply
to systematically evaluate and compare the performance of with compulsory resubmission requirements, the results of
commercially available malaria RDTs. all rounds of testing should be considered as a single data
set. The separate, full reports of each round (3–8) should be
The results of WHO’s malaria RDT product testing have been consulted for further details of methods, product performance
published annually since 2009 and form the basis of the and interpretation of the results.
procurement criteria of WHO, other United Nations agencies,
the Global Fund to Fight AIDS, Tuberculosis and Malaria,
national governments and non-governmental organiza-
1.2. The WHO product testing
tions. The data have guided procurement decisions, which, programme
in turn, have shifted markets towards better-performing
The RDT evaluations summarized here were performed in
tests (1) and are driving overall improvements in the quality
collaboration by WHO, TDR, FIND, the United States Centers
of manufacturing.
for Disease Control and Prevention (CDC) and other partners1.
WHO’s malaria RDT product testing constitutes the laboratory All companies that manufacture RDTs according to the ISO
evaluation component of WHO malaria RDT prequalification, 13485:2003 quality system standard were invited to submit
but meeting WHO prequalification criteria has not previ-
ously been a requirement for a WHO recommendation on 1 See full reports of rounds 1–7 for lists of collaborating partners.

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016) 1
 products for evaluation. In each round of testing, products their national regulatory approvals. WHO prequalification will
were evaluated against geographically diverse, cryopreserved determine the eligibility of malaria RDTs for procurement as
Plasmodium falciparum and P. vivax clinical samples diluted of 1 January 20181.
to 200 and 2000 parasites/µL with consistently comparable
concentration ranges of histidine-rich protein II (HRP2), To facilitate this transition, manufacturers with products that
Plasmodium lactate dehydrogenase (pLDH) and aldolase currently meet procurement criteria and those submitting
determined by quantitative enzyme-linked immunosorbent to future rounds of lab evaluations are required to submit
assay (ELISA) (Annex S1). In the first round of testing, 41 applications to WHO prequalification. Only those products
products from 21 manufacturers were evaluated against that meet WHO prequalification requirements by 31 December
prepared blood panels of cultured P. falciparum parasites, 2017 will be eligible for WHO procurement. An eigth round
while 29, 50, 48, 42, 41 and 46 products from 13, 23, 27, 34, of product testing started in February 2017.
22 and 27 manufacturers were evaluated in rounds 2, 3, 4, 5,
6 and 7, respectively. Of these 297 products, 293 progressed 1.3. Panel detection score and
to testing against panels of patient-derived P. falciparum and
P. vivax parasites and a parasite-negative panel. Thermal other results of the evaluation
stability was assessed after 2 months of storage at elevated The results (summarized in Figs S1–S3 and Tables S2 and S3)
temperature and humidity, and a rudimentary assessment of provide comparative data on two lots of products against a
ease of use was made. In round 6 and 7, specific observations panel of parasite samples diluted in blood to a low density
of RDT anomalies were also systematically recorded. Many (200 parasites/µL) and a higher density (2000 parasites/µL).
manufacturers have decided voluntarily to submit products to The former is well below the mean parasite density found in
one or more rounds of testing, and, in round 5, a requirement many populations with endemic malaria and is considered
was instituted to resubmit products for re-evaluation within 5 close to the threshold that must be detected in order to
years of original testing (Table S1). Of the 293 fully evaluated reliably identify clinical malaria in many settings (11). For the
products in rounds 1–7, 31 have been evaluated twice, 21 purposes of this report, the main measure of performance
have been evaluated three times, two evaluated four times is the panel detection score (PDS); for each RDT evaluated,
and three evaluated five times. Of the 202 unique products the PDS is measured separately at the lower and the higher
tested in the programme, 65 detect P. falciparum alone, 143 parasite densities. The summary figures also show the false-
detect and differentiate P. falciparum from non-P. falciparum positive rates against blood samples containing no malaria
malaria (either pan-specific or species-specific for P. vivax parasites or known markers of other diseases and the rate
or P. vivax, ovale and malariae), 10 detect P. falciparum and of invalid results.
non-P. falciparum malaria without distinguishing between
them, and one product was designed to detect P. vivax The PDS is the percentage of malaria samples in the panel
only. Manufacturers submitted two lots of each product for that give a positive result in two RDTs per lot at the lower
evaluation. When the same products (9) were resubmitted parasite density or by a single RDT per lot at the higher
in subsequent rounds of testing, the second set of results parasite density. As each sample is tested with RDTs from
replaced those from the earlier round. Thus, the performance two lots, for a sample to be positive at the lower parasite
of some tests in the results below differs from that reported density, it must show a positive result in four tests (two RDTs
in rounds 1–6. per lot for two lots); at the higher parasite density, it must
show a positive result in two tests (one RDT per lot for two
Of the 30 products due for compulsory retesting in round 7, lots). Thus, the PDS is a combined measure of positivity rate
five were submitted (Table S1). Round 3 products that were incorporating inter-test and inter-lot consistency. As all tests
not resubmitted have been removed from the figures and performed on each sample must show a positive result for
tables in this summary performance document. the sample to be considered positive, the PDS for a given RDT
will usually be lower than a simple positivity rate per panel,
Product testing is part of a continuing programme of work
measured by comparing the number of positive tests among
to improve the quality of RDTs in use and to ensure reliable
all tests performed per panel. The PDS is also different from
malaria diagnosis in areas where malaria is prevalent. The
clinical sensitivity, which is the ability of the test to detect
aim of the evaluation is to provide comparative data on
malaria infection in a given population of infected patients.
the performance of the submitted production lots of each
Boxes 1 and 2 illustrate how the PDS is calculated and how
product. Since 2009, these data have guided procurement
it differs from a simple positivity rate for all samples tested
decisions by WHO, other United Nations agencies and national
and from clinical sensitivity in a population.
governments.
The PDS for a given RDT is different from the clinical sensi-
WHO product testing has constituted the laboratory evalu-
tivity of that RDT (also called the true positive rate), which
ation component of the WHO prequalification process for
is a measure of the proportion of people known to have the
malaria RDTs (10), which additionally includes a standard-
disease who test positive for it. The sensitivity of malaria
ized dossier review and a manufacturing site inspection to
RDTs is highly dependent on local conditions, including the
ensure safety, quality and performance comprehensively.
parasite density in the population; it therefore varies among
WHO prequalification of in vitro diagnostics, established in
populations with different levels of transmission, as their level
2008, is used in all United Nations agencies to determine
the eligibility for procurement of tests for HIV, hepatitis B
and C and syphilis and by national authorities to complement 1 http://www.who.int/malaria/news/2016/rdt-procurement-criteria/en/

2 Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
 Summary Rounds 1-7
Box 1: Example calculation of panel detection score and positivity rate for product A against a sample density
of 200 parasites/µL
The first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is
considered detected only if all first test readings, from both lots, are positive, i.e. readings a, b, c and d must be positive.

Product A
Lot 1 Lot 2

Test 1 Test 2 Test 3 Test 4

a b c d Detected if
Reading Reading Reading Reading Reading Reading Reading Reading 4 positive
1 2 1 2 1 2 1 2
first readings
a second reading results are for internal use only

P. falciparum
a b c d
sample
Sample
1 + - + + NOT detected
Sample
2 + - - + NOT detected
Sample
3 + + + + detected
In this example, only one of three samples was positive all four times
it was tested; the PDS is therefore 1/3 = 33%.

The positivity rate is calculated as the percentage of all tests of a particular product that returned a positive test result at the
manufacturers’ recommended minimum reading time when tested against a P. falciparum or P. vivax sample.
In the above example, the positivity rate is: 9/12 = 75%.
The positivity rate is always greater than the PDS, except when the PDS and the positivity rate are both 100%.

Box 2: Performance measures in WHO product testing and in field settings: PDS versus clinical sensitivity
WHO Malaria RDT Product Testing Malaria endemic setting
Primary performance measure: PDS indicates which Performance measure: sensitivity is the proportion of the popu-
products are likely to be more sensitive in the field, lation studied who have malaria for whom the test is positive.
particularly in populations with low‐density infections. - high, moderate, low transmission
- immune, non-immune
- vulnerable groups

20
00
20 pa
0 ra
pa s
ra ite
site s/
s/ μL
μL
Patients have varying parasite density. Most RDTs for
Reference panels: two fixed parasite densities allows P. falciparum and P. vivax perform well for a parasite density
discrimination in RDT performance. > 2000 parasites/μL, but clinically significant densities
< 200 parasites/μL may be missed. The “overall” test performance
will nevertheless be classified as very good in a field evaluation.

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016) 3
 of immunity affects the parasite density at which they exhibit
symptoms that warrant a diagnostic test. Where transmission
1.4. Summary of outcomes
rates are low, the parasite densities in people with symptoms Laboratory-based evaluation provides a comparative, stand-
of malaria are likely to be low, and tests will be less sensitive. ardized measure of RDT performance for distinguishing
Test performance at 200 parasites/µL is therefore particularly between well and poorly performing tests to serve as a basis
important. The results in this report show the comparative for procurement decisions by malaria control programmes
performance of RDTs and indicate which products are likely and to guide United Nations procurement policy.
to be more sensitive in the field, particularly in populations
with low-density infections. In round 7, the proportion of tests that achieved a PDS ≥ 75%
at a density of 200 parasites/µL is slightly lower than in round
In general, as countries reduce the prevalence of malaria 6 for both P. falciparum (87.0%%) and P. vivax (70.0%).
and even move towards malaria elimination, detection of
low parasite densities becomes increasingly important in Several RDTs in the seven rounds of testing consistently
case management. As the high PDS at 2000 parasites/µL detected malaria at a low parasite density (200 parasites/µL),
indicates, the sensitivity of many of these products is similar had low false-positive rates, are stable at tropical tempera-
in populations with higher parasite densities; therefore, it is tures, are relatively easy to use and can detect P. falciparum
not possible to discriminate RDTs with superior performance. or P. vivax infections or both.

An important caveat to estimating field sensitivity from the Although the performance of the products varied widely
PDS provided in this report is that the panels used include at low parasite density (200 parasites/µL) in round 7, all
only parasites known to express the target antigens. While products had a high rate of detection of P. falciparum at
non-expression of the target antigens has not been recorded 2000 parasites/µL (PDS of 100%), as did the majority of
for aldolase or pLDH, it is known that parasites that infect products for P. vivax at 2000 parasites/µL.
people in some areas of South America (Peru, Colombia,
In all except two of the RDTs submitted to round 7, the HRP2
Brazil), India and Africa (Eritrea, Ghana, Rwanda) do not
antigen was used to detect P. falciparum, either alone (41
express HRP2 (12–13 , 33-34). In areas where HRP2-deleted
products) or with Pf-pLDH (3 products). In the two exceptions,
parasites exist, tests for HRP2 will have greatly reduced
Pf-pLDH was used alone. Of the five products that detected
sensitivity or be incapable of detecting P. falciparum. In such
Pf-pLDH, two combined Pf-pLDH with HRP2 in the same test
populations, only tests for pLDH or aldolase in P. falciparum
line, one had dual test lines for detecting P. falciparum (one
parasites will be effective.
HPR2 and one Pf-pLDH test line), and two had only Pf-pLDH.
Heat stability (summarized in Table S3) is vital to maintaining While the dual test line product performed well overall, the
the sensitivity of tests in the field. As a result, for procure- line for detecting Pf-pLDH performed considerably less well
ment, careful consideration must be given to ensure that than the HPR2-detecting test line at 200 µL, with a PDS
the products to be used in areas with high temperatures of 38%. The PDS of the two products with Pf-pLDH alone
of transport and storage have demonstrated stability in for detecting P. falciparum at 200 parasites/µL were 75%
the product testing programme. Requirements vary among and 73%. Thus, after seven rounds of testing, the choice
countries; for example, if tests are to be deployed in areas of well-performing pLDH-based P. falciparum tests and of
where temperatures rarely rise above 30°C, less emphasis pan-only tests remains limited.
is needed on stability at high temperatures than on other
The test performance of lots in round 7 varied only
aspects of quality.
slightly, with an average difference in positivity rates of
Ease-of-use requirements depend on the extent of training 1.5 percentage point (range, 0–4.5%) and 1.0 percentage
and the work environment of the users. Particularly in point (range, 0–3.5%) when tested against 200 parasites/µL
primary health care settings, the simpler the test, the easier wildtype P. falciparum and P. vivax, respectively (Tables
it will be to avoid errors in preparation and interpretation. A3.1 and A4.1), a pattern also seen in round 6. In previous
Certain anomalies resulting from defects in production lots rounds, however, wide variation was found, indicating the
or RDT degradation may affect the running of the test or advisability of testing lots after purchase and before use in
interpretation and may warrant a field safety notice and the field. The frequency of anomalies that can interfere with
corrective action. test interpretation was recorded for the first time in round 6.
In round 7, one to five anomalies were found with 33 of the
To encourage manufacturers to meet international standards 46 products (Annex S2, Table 8, Fig. 30). Incomplete clearing
and best practice in the packaging and labelling of malaria and a red background were the most common anomalies,
RDTs, with the goal of ensuring better, more consistent ease seen in 48% and 24% of products, respectively. The next
of use, WHO and partners have made recommendations most common anomalies were incomplete migration, failed
for the instructions for use and labelling of malaria RDTs migration and a red background obscuring the test lines, in
(14). Evaluation of adherence to the recommendations was 15%, 11% and 11% of products, respectively. Most products
introduced in round 7. (44/46) had anomalies in < 1% of the tests; two products
had anomalies in 1.4% of products (Table 8). Overall, fewer
Detailed results can be found in the report of each evalua- types and a lower frequency of anomalies were seen in round
tion (3–8) and at http://www.who.int/malaria/publications/ 7 than in round 6.
diagnostic_testing/en/ (accessed 8 March 2017).

4 Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
 Summary Rounds 1-7
All except one of the RDTs evaluated in round 7 were in local malaria transmission and illness where the tests will be
cassette format; the exception was in dipstick format. used (e.g. Plasmodium spp., target antigen, parasite densities,
climate) and other important considerations, including ease
Only 5 of the 30 RDTs due for compulsory resubmission of use in the field (Annex S2), training or retraining require-
were submitted for retesting. All met the WHO procurement ments and lot testing.1
criteria on initial testing. Two products (one for P. falciparum
only and one combination RDT) scored higher in re-testing, The results in Table S2 indicate WHO prequalification status
with percentage point increases of 7 and 6, respectively, in and are colour-coded to reflect achievement of WHO perfor-
the PDS at 200 µL against P. falciparum and an increase of mance requirements for RDT procurement. A web-based tool
6 percentage points against P. vivax for the combination that allows filtering of product testing results by various
RDT. Three re-tested products (one P. falciparum only, two parameters to assist in selecting products with the perfor-
combination RDTs) scored lower than in their initial testing, mance characteristics most suitable for a country’s health
with percentage point decreases of 7, 8 and 16 in the PDS at programme is available and is maintained by FIND (15).
200 µL against P. falciparum and a decrease of 91 percentage This online database has been updated to allow filtering
points (to a score of zero) in the PDS against P. vivax for the of results by RDT procedural characteristics, such as blood
combination RDT. Of these three products with diminished volume requirements, number of buffer drops and time to a
performance, two no longer meet the criteria for procure- result. This will allow identification of products with similar
ment. Four products showed decreased false-positive rates procedures so that, when product replacement is required,
on re-testing, whereas one had an increase from 0% to 5% another product can be selected with the same or a similar
at 200 µL. protocol. Use of similar products may reduce the need for
user retraining and reduce user error.
1.5. De-listing of products in The results in the product testing reports are presented by
summary report product, which are described by their name and “product
code”. The same RDT may be sold in a variety of product
Products that are due for compulsory resubmission (every configurations, such as single or multi-kits, the number of
5 years) but are not resubmitted are removed from the tests per box, with or without certain accessories, and they
summary results listing (Tables S2 and S3) and the online are assigned a series of distinct product codes on this basis.
interactive database (15) and are featured only in the full The reports lists the precise name and product code as
round-specific product testing report. They are also not provided by the manufacturer for testing. Procurers should
eligible for WHO procurement. Furthermore, a product is contact the manufacturer for a list of product configurations
de-listed if WHO is notified by the manufacturer that its before purchase.
production has been discontinued. To date, 72 products have
been delisted (Table S4). Comprehensive guidance on several aspects of procure-
ment can be found in Recommended selection criteria for
procurement of malaria rapid diagnostic tests (16), published
1.6. How product testing results as a WHO information note in 20162 and Good practices for
can inform RDT procurement selecting and procuring rapid diagnostic tests for malaria (16).
and use Guidance on implementation is provided in Universal access
to malaria diagnosis (17).
Accurate diagnosis is vital to good malaria case manage-
ment, whether based on microscopy or on RDTs. The results 1 The WHO-FIND malaria RDT evaluation programme provides lot-testing
of this report should be used to make a short list of RDTs
capacity in two regional laboratories free of charge. Information on
for procurement for use in settings where good microscopy the programme and how to access it can be found at: https://www.
is not available or appropriate. Box 3 lists WHO’s minimum finddx.org/malaria-rdt-qa/ (accessed 8 March 2017).
criteria for RDT selection, and Annex S3 provides a step-by- 2 http://www.who.int/malaria/publications/atoz/rdt-selection-criteria.
step approach to selecting an RDT, taking into consideration pdf (accessed 3 April)

Box 3: WHO selection criteria for the procurement of RDTs

Products should be selected in line with the following set of criteria, based on the results of the assessment of the WHO Malaria
RDT Product Testing Programme:
(A) For the detection of Plasmodium falciparum (Pf) in all transmission settings the panel detection score (PDS) against Pf samples
should be at least 75% at 200 parasites/μl.
(B) For the detection of Plasmodium vivax (Pv) in all transmission settings the panel detection score (PDS) against Pv samples
should be at least 75% at 200 parasites/μl.
(C) The false positive rate should be less than 10%.
(D) The invalid rate should be less than 5%.
Only products meeting performance criteria outlined in A,B,C and D are recommended for procurement
As of 1 January, 2018 WHO procurement recommendations for malaria RDTs will change to require WHO prequalification designation1.

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016) 5
 Figure S1: Malaria RDT performance in phase 2 of rounds 4–7 against wild-type (clinical) samples containing P. falciparum
at low (200) and high (2000) parasite density (parasites/µL) and clean-negative samples

100
90
80
Panel detection scorea

70
60
50
40
30
20
10
0

a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive.
b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.
* Indicates tests that also detect other non-P. falciparum parasites

1.7. Product testing and WHO programme for prequalification of

diagnostics and medical devices
In the WHO programme for prequalification of diagnostics 2018, WHO prequalification will become a requirement for
and medical devices, the results of product testing are used WHO procurement. Therefore, manufacturers are strongly
as the laboratory evaluation component of the prequalifica- encouraged to apply.1 Prequalified RDTs are listed in summary
tion process for malaria RDTs. These data are used to set tables and at http://www.who.int/diagnostics_laboratory/
priorities for dossier review and inspection. As of 1 January evaluations/PQ_list/en/ (accessed 8 March 2017).

1 http://www.who.int/malaria/news/2016/rdt-procurement-criteria/en/

6 Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
 Summary Rounds 1-7
100

rate on clean-negative samplesb (%)

False-positive Plasmodium spp.
80

and invalid rate (%)

60

40

20

200 parasites/µl
2000 parasites/µl
False-positive Plasmodium spp. rate (%)
Invalid rate (%)

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016) 7
 Figure S2: Malaria RDT performance in phase 2 of rounds 4–7 against wild-type (clinical) samples containing
P. vivax at low (200) and high (2000) parasite density (parasites/µL) and clean-negative samples

100
90
80
Panel detection scorea

70
60
50
40
30
20
10
0

a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive.
b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.

8 Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
 Summary Rounds 1-7
100

rate on clean-negative samplesb (%)

False-positive Plasmodium spp.
80

and invalid rate (%)

60

40

20

200 parasites/µl
2000 parasites/µl
False-positive Plasmodium spp. rate (%)
Invalid rate (%)

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016) 9
 Figure S3: Panel detection score of malaria combination RDTs meeting WHO procurement criteria for false-positive
and invalid rates, in phase 2 of rounds 4–7 against wild-type (clinical) samples containing P. falciparum and P. vivax
at low parasite density (200 parasites/μL)

32 11 & 12
100 100 74 69 61 55 37
18 13 4 & 9
Panel detection score P. vivaxa

Panel detection score P. vivaxa

92
62 19 8 2
80 75 95 20 & 23
24 5
45, 46 & 47 25 14 6
63 60 39 3
60 90 33 & 38 15
65 64 56 48 7
66 & 67 49
40 85
68 54 26 21

20 80 30 10
73
31
0 75
0 20 40 60 80 100 75 80 85 90 95 100
Panel detection score P. falciparuma Panel detection score P. falciparuma
50 & 51
70
59 52
Panel detection score P. vivaxa

Panel detection score P. vivaxa

79 27
41 34 16
72 57
60 60 58
40 35
28
22
80
40 84 82
76 40 36
53
17 1
29
20 20
81 71
89 42 & 44
87 83 78
91 90 86 & 88 85 77 43
0 0
0 20 40 60 75 80 85 90 95 100
Panel detection score P. falciparuma Panel detection score P. falciparuma
1 Core™ Malaria Pan Pf - MAL - 190024 47 SD Bioline Malaria Ag P.f/P.f/P.v - 05FK120
2 BioTracer™ Malaria P.f/PAN Rapid Card - 17012 48 Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv - 11108191040
3 SD BIOLINE Malaria Ag P.f/Pan - 05FK60 49 Biosynex® Malaria Pf/Pan - 0584_K25
4 Is It... Malaria Pf PAN - MPFPAN050 50 First Response® Malaria Ag. pLDH/HRP2 Combo Card Test - I16FRC
5 CareStart ™ Malaria Screen RDT - RMAM-05071 51 Malaria Pf (HRPII)/ PV (PLDH) Antigen Detection Test Device - GM006
6 Aspen® Malaria Ag Pf/Pv - AS0060 52 First Response® Malaria Ag Pf/Pv Card Test - PI19FRC
7 careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082 53 ICT MALARIA DUAL TEST - ML03
8 NanoSign Malaria pf/pan Ag 3.0 - RMAP10 54 ParaHIT - Total Ver. 1.0 (Device) - 55IC204-10
9 Humasis Malaria P.f/P.v Antigen Test - AMFV-7025 55 Advantage Malaria Pan + Pf Card - IR231025
10 RAPID 1-2-3 ® HEMA CASSETTE MALARIA PF/PV TEST - MAL-PFV-CAS/25(100) 56 CareStart ™ Malaria PAN (pLDH) Ag RDT - RMNM(U)-XXX7X
11 Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25 57 Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test - MAT-PF/PAN-50
12 One Step Malaria P.F/P.V Test (Cassette) - 523352 58 GenBody™ Malaria Pf/Pan Ag - MALAG100
13 ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test - ITP11003-TC25 59 BIONOTE MALARIA P.f & Pan Ag Rapid Test Kit - RG19-08
14 SD Bioline Malaria Ag P.f/P.v - 05FK80 60 First Response® Malaria Ag. pLDH/HRP2 Combo Card Test - PI16FRC
15 RapiGEN BIOCREDIT Malaria Ag Pf/Pv (HRPII/pLDH) - C40RHA25 61 FalciVax™ - Rapid Test for Malaria Pv/Pf - 503010025
16 One Step Malaria HRP2/pLDH (P.f/P.v) Test - W056-C 62 Parascreen® - Rapid Test for Malaria Pan/Pf - 503030025
17 NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005 63 QuickProfile™ Malaria Pf/Pan Test - 71063
18 BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25 64 QuickProfile™ Malaria Pf/Pv Antigen Test - 71050
19 CareStart ™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-03091 65 EzDx™ Malaria Pan/Pf Rapid test detection Kit - RK MAL 001
20 BioTracer™ Malaria P.f/P.v Rapid Card - 17412 66 OnSite Malaria Pf/Pan Ag Rapid Test - R0113C
21 PALUTOP +4 optima® - 5499 67 One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02
22 KHB ® Malaria Ag P.f/P.v Rapid Test - KH-R-07-50 68 Coretests® One Step Malaria Pf/Pv Ag Test Device - B42-21/B42-22
23 SD BIOLINE Malaria Ag Pf/ Pan - 05FK66 69 Advantage Pan Malaria Card - IR013025
24 CareStart ™ Malaria Pf/PAN (HRP2/pLDH) Ag COMBO RDT - RMRM(U)-XXX7X 70 Meriscreen Malaria Pf/Pan Ag - MHLRPD-01
25 Humasis Malaria P.f/Pan Antigen Test - AMAL-7025 71 One Step Malaria P.f/Pan Whole Blood Test - W62-C
26 DIAQUICK Malaria P.f/Pan Cassette - Z11200CE 72 ParaHIT - Total Ver. 1.0 (Dipstick) - 55IC203-10
27 NG-Test MALARIA Pf/Pan (pLDH) - NG-MAL-W23-001 73 EzDx™ Malaria Pv/Pf Rapid Malaria antigen detection test - RK MAL 003
28 Malaria PV/PF (pLDH/HRP2) Antigen Test- Inf-72 74 BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) - C60RHA25
29 ATOMORAPID™ MALARIA (PF/PAN) - MMAL01 75 OnSite Malaria Pf/Pv Ag Rapid Test - R0112C
30 HiSens Malaria Ag P.f/P.v Combo Card - HR3123 76 RightSign™ Malaria P.f./Pan Rapid Test Cassette - IMPN-C52
31 HiSens Malaria Ag P.f/VOM Combo Card - HR3323 77 CareStart ™ Malaria Pf/PAN (pLDH) Ag RDT - RMLM-05071
32 CareStart ™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT - RMVM-05072 78 MeDiPro Malaria Ag HRP2/pLDH Combo - IR-0051K
33 Malaria Pf/Pan One Step Rapid Test - RT 20222 79 AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402
34 Humasis Malaria P.f/Pan Antigen Test - ANMAL-7025 80 Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016
35 Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a 81 Genedia® Malaria P.f/Pan Ag Rapid Test- 20-0146-01
36 Trusty™ Malaria Antigen P.f./p.v. test - A03-12-322 82 ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test - MAGC 25
37 Asan Easy Test ® Malaria Pf/Pan Ag - AM4650-K 83 Malaria pf (HRP II)/PAN (pLDH) Antigen Detection Test Device - 1-13-101-1
38 Is ItÖ Malaria Pf/Pv Device - AL030 84 ParaHIT® fV Rapid test for P. falciparum and P. vivax Malaria - Device - 55IC402-50
39 Humasis Malaria P.f/P.v Antigen Test - ANMIV-7025 85 AZOG Malaria pf (HRPII)/pf (LDH)/ (PAN-LDH) Antigen Detection Device - MFV-124F
40 Advanced Quality™ Rapid Malaria Test (Pf/Pan) - ITP11005 86 AZOG hCG Malaria Detection Test Device - MPT-124
41 FirstSign™ ParaView (Pan+Pf) - 2101CB-25 87 Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit - A03-18-322
42 Vikia® Malaria Ag Pf/Pan - 412499 88 Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device - 1-13-101-3
43 Malaria Pf/PAN Test - PROMALPFV001 89 Malaria pf (pLDH) / PAN-pLDH Test Device - MFV-124
44 ABON™ Plus Malaria P.f/Pan Rapid Test Device (Whole Blood) - IMA-T402 90 Malaria Pf/Pv - GM002
45 Alere Trueline™ - Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40 91 Malaria Pf/ PAN - GM004
46 Biosynex® Malaria Pf/Pv - 0581_K25 92 Advantage Mal Card - IR221025
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive.

10 Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
 Summary Rounds 1-7
Table S1: Product resubmissions: WHO malaria RDT product testing rounds 1—7
Product resubmission
Manufacturer Product name Product code* Round
Voluntary Compulsory
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-05072a 2, 4, 7
CareStart™ Malaria HRP2/PLDH (Pf/VOM) COMBO RMWM(U)-XXX7Xb 2, 4
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM(U)-XXX7Xc 1 5
CareStart™ Malaria HRP2/pLDH (Pf/PAN) Combo RMRM(U)-XXX7X 1 5
Access Bio, Inc.
CareStart™ Malaria PAN (pLDH) Ag RDT RMNM(U)-XXX7Xe 1 5
CareStart™ Malaria Pf (HRP2/pLDH) Ag RDT RMPM(U)-XXX7Xf 2 6
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071g 3 7
CareStart™ Malaria Screen RDT RMAM-05071h 3 7
Advy Chemical Pvt. Ltd. (Affiliate of
EzDx™ Malaria Pan/Pf Rapid Test Detection Kit RK MAL 001 4, 5, 6
Bharat Serums & Vaccines Ltd. )
ParaHIT® - f (Device)j 551C104-50 3 7
ARKRAY Healthcare Pvt. Ltd.i
ParaHIT® - f (Dipstick)k 551C103-50 3 7
ASAN Pharmaceutical Co., Ltd Asan Easy Test® Malaria Pf/Pan Ag AM4650-K 5, 7
Malaria pf (HRP II) / (PAN-LDH) Antigen Detection Test Device l MFV-124R 1, 3
AZOG
Malaria pf (pLDH) / PAN-pLDH Test Device MFV-124 3, 5
Bhat Bio-Tech India (P) Ltd. Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test MAT-PF/PAN-50 4, 5
Bioland NanoSign Malaria Pf/Pan Ag RMAP10 3, 4
BIONOTE MALARIA P.f. Ag Rapid Test Kit RG19-11 3, 6
Bionote, Inc.
BIONOTE MALARIA P.f & Pan Ag Rapid Test Kit RG19-08 3, 6
Biosynex IMMUNOQUICK® MALARIA falciparum 0502_K25 1 5
Bio Focus Co., Ltd. BioTracerTM Malaria P.f/PAN Rapid Card 17012 5, 6, 7
One Step Malaria Pf Test (cassette) 522352 2, 3, 4
Blue Cross Bio-Medical (Beijing) Co., Ltd.
One Step Malaria P.F/P.V Test (Cassette) 523352 4, 5
Onsite Pf Ag Rapid Test R0114C 2, 3, 6
CTK Biotech, Inc. Onsite Malaria Pf/Pan Malaria Ag Rapid Test R0113C 2, 3, 4, 5, 6
Onsite Malaria Pf/Pv Ag Rapid Test R0112C 2, 3, 4, 6
DiaMed - A Division of Bio-Rad OptiMAL-IT 710024 1, 3
Wondfo One Step Malaria Pf/Pan Whole Blood Test W56-C 1, 3
Guangzhou Wondfo Biotech Co. Ltd. One Step Malaria P.f/P.v Whole Blood Test W056-C 5, 6, 7
One Step Malaria P.f Testm W37-C 2, 3, 4, 6, 7
Humasis Co., Ltd. Humasis Malaria Pf/Pan Antigen Test AMAL-7025 4, 5
ICT Malaria Combo Cassette Test ML02 1, 3, 4
ICT INTERNATIONAL ICT Malaria Pf Cassette Test ML01 1, 3 7
ICT Malaria Dual Test ML03 3, 5, 7
Advanced Quality™ One Step Malaria Pf Test ITP11002TC1/TC40 1, 3, 7 5
InTec Products, Inc.
Advanced Quality ™One Step Malaria (Pf/Pv) Tri-line Test (whole blood) ITP11003 TC40 3, 6, 7
Advantage Pan Malaria Card IR013025 1 5
J.Mitra & Co. Pvt. Ltd. Advantage Mal Card IR221025 1 5
Advantage P.f Malaria Card IR016025 1 5
Lumiquick Diagnostics Inc. QuickProfileTM Malaria Pf/Pv Antigen Test 71050 6, 7
Paracheck® Pf Device - Rapid test for P. falciparum Malaria (Ver. 3)n 30301025 1, 3, 4
Orchid Biomedical Systems
Paracheck® Pf Dipstick - Rapid test for P. falciparum Malaria (Ver.3)n 30302025 1, 3, 4
First Response® Malaria Ag Combo (pLDH/HRP2)o I16FRC25 1, 2, 5
Premier Medical Corporation Ltd.
First Response Malaria Ag P. falciparum(HRP2) Card Test I13FRC25 1 5
RapiGEN Inc. BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C30RHA25 5, 6, 7
SSA Diagnostics & Biotech Systems diagnosticks- Malaria (Pf)Cassette WB KMFC6001 2, 5
SD BIOLINE Malaria Ag 05FK40 1, 3
SD BIOLINE Malaria Ag Pf/Pan 05FK60 1, 3, 5
Standard Diagnostics Inc. SD BIOLINE Malaria Antigen 05FK50 1 5
SD Bioline Malaria Ag P.f (HRP2/pLDH) 05FK90 3, 6
SD Bioline Malaria Ag P.f/P.v 05FK80 2 6
Unimed International Inc. FirstSign™ - ParaView (Pan+Pf) Malaria Test 2101 CB-25 2, 4
Malaria Rapid Combo/Clearview® Malaria Combo VB11p 1, 3
Vision Biotech (Pty) Ltd / Orgenics
Malaria Rapid Pf /Clearview ®Malaria Pf VB01 1, 3, 5
(Alere Healthcare (Pty) Ltd subsidaries)
Malaria Rapid Dual/Clearview® Malaria Dual Test Device VB20p 1, 3, 5
Malascan™ Device - Rapid test for Malaria Pf/Pan 50402025 1, 3
Parabank™ Device - Rapid test for Malaria Pan 50301025 1, 3
Zephyr Biomedical Systems
Parascreen™ Device -Rapid test for Malaria Pan/Pf 50310025; 503030025 (rd 6) 1, 3, 4, 5, 6
Falcivax Rapid Test for Malaria Pv/Pf (device) 50300025; 503010025 (rd 6) 2, 4, 6
* The product code corresponds to a specific configuration of the RDT, kit components and accessories. Therefore, changes to this configuration including the quantity of
tests, the contents or the manufacturing site are denoted by a different product code. Often this involves the end portion of the product code; however, the manufacturer
should be contacted for full details.
a Previously listed with product code G0161 for the Access Bio Inc product. Previously co-listed with G0161-ET, the equivalent Access Bio Ethiopia product. Access Bio
Ethiopia products are now listed as separate products from separate manufacturers and not considered resubmissions.
b Previously listed with product code G0171 for the Access Bio Inc product. Previously co-listed with G0171-ET, the equivalent Access Bio Ethiopia product. Access Bio
Ethiopia products are now listed as separate products from separate manufacturers and not considered resubmissions.
c Previously listed with product code G0141 for the Access Bio Inc product. Previously co-listed with G0141-ET, the equivalent Access Bio Ethiopia product. Access Bio
Ethiopia products are now listed as separate products from separate manufacturers and not considered resubmissions.
d Previously listed with product code G0131/G0131-ET
e Previously listed with product code G0111
f Previously listed with product code G0181/G0181-ET
g Previously listed with product code G0121
h Previously listed with product code G0231
I Arkray Healthcare Pvt. Ltd. was formerly Span Diagnostics Ltd.
j New product codes have been in place since round 3, the previous code was 55IC102-10.
k New product codes have been in place since round 3, the previous code was 55IC101-10.
l Round 1 product name error : published - Malaria Pf (HRPII)/pv-LDH) Antigen Detection Test Device Code ; corrected product name: Malaria Pf (HRPII/PAN-LDH)
Antigen Detection Test Device Code. No change in product code.
m In round 2, product did not pass phase 1, therefore results do not feature in summary tables.
n Ver.3 was introduced after round 1
o Error in WHO Malaria RDT product testing: round 1 report: product code (II6FRC30) should have been ( I16FRC ), as in round 2
p New company acquisition (Alere™), therefore change in product branding and catalogue numbers; VB011 to VB11 and VB020 to VB20. Manufacturer confirmed compliance
with product definition.

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016) 11
 12
Table S2: Malaria RDT phase 2 performance in rounds 4–7 against wild type (clinical) samples containing P. falciparum and P. vivax at low (200) and high (2000) parasite density (parasites/μl) and
clean-negative samples

Panel detection scorea False positive rates (%) Total false positive
ratesb (%)
200 2000 or 5000 200 2000
parasites/µl parasites/µl parasites/µl parasites/µl Clean negative Invalid Meets
Product Product code Manufacturer samples WHO
Pf samples Pv samples Pf samples Pv samples rate Round procurement
(%)l criteria
False False False False

Pf
Pf
False positive

Pv
Pv
positive positive positive positive Plasmodium spp.

samplesc
samplesc

samplesd
samplesd
non-Pf Pf non-Pf Pf Infectioni
infectione infectionf infectiong infectionh
Pf only
ABON™ Malaria P.f. Rapid Test Device (Whole Blood) IMA-402 ABON Biopharm (Hangzhou) Co. Ltd 32.7 NA 99.0 NA NA 0.0 NA 0.0 0.4 0.0 4 No
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 80.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 0.0 7 Yes
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test j ITP11002-TC25 InTec Products, Inc. 93.0 NA 99.0 NA NA 0.0 NA 0.0 0.4 0.0 7 Yes
Advantage P.f. Malaria Card IR016025 J. Mitra & Co. Pvt. Ltd. 89.0 NA 99.0 NA NA 0.7 NA 0.0 0.0 0.0 5 Yes
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 98.0 NA 100.0 NA NA 0.0 NA 0.0 0.9 (231) 0.1 7 Yes
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 93.0 NA 100.0 NA NA 0.7 NA 0.0 1.3 0.0 7 Yes
BIONOTE MALARIA P.f. Ag Rapid Test Kit RG19-11 Bionote,Inc. 88.0 NA 100.0 NA NA 0.0 NA 0.0 0.5 0.0 6 Yes
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 97.0 NA 99.0 NA NA 0.0 NA 0.0 0.0 0.0 7 Yes
CareStart™ Malaria HRP2 (Pf) RMOM(U)-XXX7X Access Bio, Inc. 91.0 NA 100.0 NA NA 0.0 NA 0.0 0.9 0.0 5 Yesm
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 96.0 NA 100.0 NA NA 0.0 NA 0.0 0.4 0.0 7 Yes
CareStart™ Malaria Pf (HRP2/pLDH) Ag RDT RMPM(U)-XXX7X Access Bio, Inc. 91.0 NA 99.0 NA NA 0.7 NA 0.0 0.0 0.0 6 Yesm
94.0 99.0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line k RMSM-05071 Access Bio, Inc. NA NA NA 2.1 NA 1.4 0.4 0.0 7 Yes
(94/38) (99/92)
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 94.0 NA 100.0 NA NA 0.0 NA 0.0 0.9 0.0 7 Yes
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 86.0 NA 99.0 NA NA 0.0 NA 0.0 0.0 0.0 7 Yes
EzDx™ Malaria Pf Rapid Malaria antigen detection test RK MAL 008 Advy Chemical Private Limited 71.0 NA 100.0 NA NA 1.4 NA 1.4 1.0 0.1 6 No
First Response® Malaria Ag P. falciparum (HRP2) Card Test I13FRC25 Premier Medical Corporation Ltd. 95.0 NA 100.0 NA NA 0.7 NA 0.0 0.4 0.0 5 Yesm
First Response® Malaria Ag P. falciparum (HRP2) Card Test PI13FRC Premier Medical Corporation Ltd. 91.0 NA 100.0 NA NA 0.0 NA 0.0 1.0 0.0 6 Yes
FirstSign™ Malaria Pf 2100CB-25 Unimed International Inc. 94.9 NA 100.0 NA NA 0.7 NA 1.5 2.2 (231) 0.2 4 Yes
Humasis Malaria P.f Antigen Test ANMPF-7025 Humasis Co., Ltd. 87.0 NA 100.0 NA NA 1.4 NA 1.4 1.4 0.0 6 Yes
ICT MALARIA P.F. CASSETTE TEST j ML01 ICT INTERNATIONAL 94.0 NA 100.0 NA NA 5.0 NA 1.4 1.7 0.0 7 Yes
IMMUNOQUICK® MALARIA falciparum 0502_K25 Biosynex 72.0 NA 93.0 NA NA 3.6 NA 4.3 5.1 (234) 0.2 5 No
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co.,Ltd. 85.0 NA 99.0 NA NA 0.0 NA 0.0 0.0 0.0 7 Yes
91.8
KHB® Malaria Ag P.f Rapid Test KH-R-06-20 Shanghai Kehua Bio-engineering Co.,Ltd. 79.0 NA NA NA 11.4 NA 12.9 10.6 (235) 0.7 5 No
(98)
Malaria Antigen Test-Pf MAG01040 Oscar Medicare Pvt. Ltd. 91.0 NA 100.0 NA NA 1.4 NA 1.4 1.0 0.0 6 Yes
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 89.0 NA 100.0 NA NA 0.0 (139) NA 0.0 0.0 0.1 7 Yes
Maleriscan ® Malaria P.f Antigen Test MAT-PF-50 Bhat Bio-Tech India (Pte.) Ltd. 83.7 NA 98.0 NA NA 1.5 NA 0.0 0.4 0.2 4 Yes
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 86.0 NA 99.0 NA NA 2.9 NA 1.4 0.4 (231) 0.1 7 Yes
One Step Malaria HRP2 (P.f) Test j W37-C Guangzhou Wondfo Biotech Co., Ltd. 93.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 0.0 7 Yes

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
One Step Malaria P.F Test (Cassette) 522352 Blue Cross Bio-Medical (Beijing) Co., Ltd. 94.9 NA 99.0 NA NA 0 NA 1.5 1.3 0.0 4 Yes
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag MPHRPD-01 Meril Diagnostics Pvt. Ltd. 73.0 NA 99.0 NA NA 0.7 NA 0.0 0.0 0.0 7 No
OnSite Malaria Pf Ag Rapid Test R0114C CTK Biotech, Inc. 75.0 NA 99.0 NA NA 0.0 NA 0.0 0.0 0.2 6 Yes
PALUTOP + pf® 5531 ALLDIAG SA 92.0 NA 99.0 NA NA 0.0 NA 0.0 0.0 0.0 7 Yes
Paracheck® Pf-Rapid Test for P.falciparum Malaria Device (Ver.3) 302030025 Orchid Biomedical Systems 95.9 NA 98.0 NA NA 0.0 NA 0.0 1.3 0.0 4 Yes
Paracheck® Pf-Rapid Test for P.falciparum Malaria Dipstick (Ver.3)j 302040025 Orchid Biomedical Systems 70.4 NA 99.0 NA NA 0.0 NA 0.0 0.9 0.0 4 No
Parahit f® Ver 1.0 - Dipstick j 55IC103-50 ARKRAY Healthcare Pvt Ltd n 74.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 0.0 7 No
Parahit® f Ver 1.0 - Device j 55IC104-50 ARKRAY Healthcare Pvt Ltd n 77.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 0.0 7 Yesm
Rapid 1-2-3® Hema® Cassette Malaria PF MAL-PF-CAS/25 (100) Hema Diagnostic Systems 93.0 NA 100.0 NA NA 2.9 (139) NA 0.0 0.0 0.2 6 Yes
RapiGEN BIOCREDIT Malaria Ag Pf (HRPII) C10RHA25 RapiGEN Inc. 88.0 NA 99.0 NA NA 0.7 NA 0.0 0.5 (207) 0.2 6 Yes
RightSign® Malaria P.f. Rapid Test Cassette (Whole Blood) IMPF-C51 Hangzhou Biotest Biotech Co., Ltd. 79.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 0.0 6 Yes
 Table S2 (continued)
Panel detection scorea False positive rates (%) Total false positive
ratesb (%)
200 2000 or 5000 200 2000
parasites/µl parasites/µl parasites/µl parasites/µl Clean negative Invalid Meets
Product Product code Manufacturer samples WHO
Pf samples Pv samples Pf samples Pv samples rate Round procurement
(%)l criteria
False False False False

Pf
Pf
False positive

Pv
Pv
positive positive positive positive Plasmodium spp.

samplesc
samplesc

samplesd
samplesd
non-Pf Pf non-Pf Pf Infectioni
infectione infectionf infectiong infectionh
88.0 100.0
SD Bioline Malaria Ag P.f (HRP2/pLDH)k 05FK90 Standard Diagnostics, Inc. NA NA NA 0.7 NA 0.0 0.0 0.0 6 Yesm
(87/52) (100/97)
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 90.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 (231) 0.1 7 Yes
SD BIOLINE Malaria Ag Pf 05FK50 Standard Diagnostics, Inc. 95.0 NA 99.0 NA NA 0.0 NA 2.9 0.0 0.0 5 Yesm
Trusty™ Malaria Antigen P.f. test A03-01-322 Artron Laboratories Inc. 88.8 NA 100.0 NA NA 4.4 (135) NA 2.9 5.2 (230) 0.7 4 Yes
Pf and Pan
ABON™ Plus Malaria P.f/Pan Rapid Test Device (Whole Blood) IMA-T402 ABON Biopharm (Hangzhou) Co. Ltd 85.7 5.9 100.0 97.1 0.0 0.0 0.0 0.0 0.4 0.0 4 No
ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test MAGC 25 LAB-CARE Diagnostics (India) PVT. LTD. 66.0 37.1 92.0 97.1 0.3 0.0 (139) 0.0 (199) 0.0 7.3 (234) 0.4 5 No
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 67.0 45.7 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 7 No
Advanced Quality™ Rapid Malaria Test (Pf/Pan) ITP11005 InTec Products, Inc. 88.0 60.0 100.0 97.1 0.3 (389) 6.7 (134) 0.0 (197) 1.4 8.7 (231) 2.1 5 No
Advantage Mal Card IR221025 J. Mitra & Co. Pvt. Ltd. 30.0 94.3 94.0 97.1 1.5 0.7 0.5 0.0 0.4 0.0 5 No
Advantage Malaria Pan + Pf Card IR231025 J. Mitra & Co. Pvt. Ltd. 84.0 100.0 100.0 100.0 3.5 0.0 0.0 0.0 (69) 0.0 0.2 5 Yes
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 85.0 91.4 98.0 100.0 1.3 0.0 1.0 0.0 0.0 0.0 7 Yes
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 69.0 71.4 96.0 100.0 1.3 0.0 2.0 0.0 0.9 0.0 7 No
Asan Easy Test® Malaria Pf/Pan Ag j AM4650-K ASAN Pharmaceutical Co., Ltd 88.0 100.0 98.0 100.0 0.5 (399) 0.0 1.0 0.0 1.3 0.1 7 Yes
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 93.0 91.4 98.0 100.0 0.3 (399) 1.4 (138) 1.0 0.0 1.3 (231) 0.3 7 Yes
ATOMORAPID™ MALARIA (PF/PAN) MMAL01 Atomo Diagnostics PTY Limited 90.0 22.9 100.0 97.1 0.0 (399) 2.9 0.0 0.0 0.0 (207) 0.2 6 No
AZOG Malaria pf (HRPII)/pf (LDH)/ (PAN-LDH) Antigen 62.2 98.0
MFV-124F AZOG, INC. 0.0 88.2 0.0 (390) 5.2 0.0 0.0 1.7 (231) 0.3 4 No
Detection Devicek (62/3.1) (98/37.8)
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) j C32RHA25 RapiGEN Inc. 91.0 100.0 99.0 100.0 0.0 0.0 0.5 0.0 3.9 0.0 7 Yes
BIONOTE MALARIA P.f & Pan Ag Rapid Test Kit RG19-08 BioNote, Inc. 83.0 68.6 100.0 100.0 0.0 0.0 0.0 0.0 0.5 0.0 6 No
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 85.0 85.7 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 7 Yes
BioTracer™ Malaria P.f/PAN Rapid Card j 17012 Bio Focus Co., Ltd. 96.0 97.1 99.0 94.3 0.8 0.7 0.5 2.9 0.9 0.0 7 Yes
CareStart™ MALARIA Pf/PAN (pLDH) Ag RDT j RMLM-05071 Access Bio, Inc. 73.0 0.0 100.0 71.4 0.0 0.7 0.0 0.0 1.7 0.0 7 No
CareStart™ Malaria Pf/PAN (HRP2/pLDH) Ag COMBO RDT RMRM(U)-XXX7X Access Bio, Inc. 90.0 94.3 100.0 100.0 1.5 0.7 0.0 0.0 0.4 0.0 5 Yesm
CareStart™ Malaria Screen RDT j RMAM-05071 Access Bio, Inc. 93.0 94.3 99.0 97.1 1.3 0.0 0.5 0.0 0.0 (231) 0.1 7 Yes
Core™ Malaria Pan Pf MAL-190024 Core Diagnostics Ltd. 99.0 26.5 100.0 29.4 0.0 33.8 0.0 42.7 32.2 (230) 0.3 4 No
DIAQUICK Malaria P.f/Pan Cassette Z11200CE DIALAB GmbH 90.0 82.9 100.0 97.1 0.3 2.9 0.0 1.5 (67) 2.1 0.2 5 Yes
EzDx™ Malaria Pan/Pf Rapid test detection Kit RK MAL 001 Advy Chemical Private Limited 78.0 88.6 100.0 100.0 0.3 0.0 0.0 0.0 1.4 0.0 6 Yes
First Response® Malaria Ag. pLDH/HRP2 Combo Card Test I16FRC Premier Medical Corporation Ltd. 85.0 74.3 100.0 100.0 0.3 0.0 0.0 0.0 0.0 0.0 5 No
First Response® Malaria Ag. pLDH/HRP2 Combo Card Test PI16FRC Premier Medical Corporation Ltd. 82.0 91.4 100.0 100.0 1.5 0.0 0.0 0.0 1.9 (207) 0.1 6 Yes
FirstSign™ ParaView (Pan+Pf) 2101CB-25 Unimed International Inc. 87.8 61.8 100.0 100.0 0.3 1.5 0.0 0.0 2.6 0.0 4 No
GenBody™Malaria Pf/Pan Ag MALAG100 GenBody Inc. 84.0 54.3 100.0 97.1 0.0 0.0 0.0 0.0 0.0 (235) 0.2 5 No
Genedia® Malaria P.f/Pan Ag Rapid Test 20-0146-01 Green Cross Medical Science Corp. (Korea) 67.0 17.1 96.0 88.6 0.0 13.6 0.0 7.1 10.6 0.1 5 No
Humasis Malaria P.f/Pan Antigen Test AMAL-7025 Humasis, Co., Ltd. 90.0 91.4 100.0 97.1 0.5 (396) 0.0 (138) 0.0 (199) 1.4 0.9 (235) 0.7 5 Yes
Humasis Malaria P.f/Pan Antigen Test ANMAL-7025 Humasis Co., Ltd. 89.0 62.9 99.0 97.1 0.0 0.7 (139) 0.0 1.4 0.5 0.1 6 No
ICT MALARIA DUAL TEST j ML03 ICT INTERNATIONAL 85.0 31.4 98.0 100.0 0.3 0.0 1.0 0.0 1.3 0.0 7 No
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 93.0 100.0 99.0 100.0 2.0 0.0 0.5 0.0 3.9 0.0 7 Yes
Is It… Malaria Pf/Pv Device AL030 Medsource Ozone Biomedicals 88.0 91.4 99.0 100.0 0.5 (395) 0.0 0.0 0 (68) 1.0 (206) 0.8 6 Yes

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
Malaria pf (HRP II)/PAN (pLDH) Antigen Detection Test Device 1-13-101-1 United Biotech, Inc. 63.3 2.9 100.0 85.3 0.0 0.0 (135) 0.0 0.0 0.0 0.1 4 No
Malaria pf (pLDH) / PAN-pLDH Test Device MFV-124 AZOG, Inc. 41.0 8.6 97.0 45.7 22.5 47.9 1.5 35.7 81.3 (235) 0.1 5 No
Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit A03-18-322 Artron Laboratories Inc. 61.0 2.9 95.0 97.1 0.0 (3.98) 4.3 0.0 (199) 0.0 0.9 0.2 5 No
Malaria Pf/ PAN GM004 Genomix Molecular Diagnostics Pvt.Ltd. 39.8 2.9 94.9 97.1 0.3 0.7 0.0 0.0 0.0 0.0 4 No

(continued)

Summary Rounds 1-7

13
 14
Table S2: Malaria RDT phase 2 performance in rounds 4–7 against wild type (clinical) samples containing P. falciparum and P. vivax at low (200) and high (2000) parasite density (parasites/μl)
and clean-negative samples (continued)

Panel detection scorea False positive rates (%) Total false positive
ratesb (%)
200 2000 or 5000 200 2000
parasites/µl parasites/µl parasites/µl parasites/µl Clean negative Invalid Meets
Product Product code Manufacturer samples WHO
Pf samples Pv samples Pf samples Pv samples rate Round procurement
(%)l criteria
False False False False

Pf
Pf
False positive

Pv
Pv
positive positive positive positive Plasmodium spp.

samplesc
samplesc

samplesd
samplesd
non-Pf Pf non-Pf Pf Infectioni
infectione infectionf infectiong infectionh
Malaria Pf/Pan One Step Rapid Test RT 20222 Zhejiang Orient Gene Biotech Co., Ltd. 89.0 91.4 100.0 100.0 0.0 (398) 0.7 (138) 0.0 (199) 0.0 (69) 0.4 (232) 1.0 5 Yes
MeDiPro Malaria Ag HRP2/pLDH Combo IR-0051K Formosa Biomedical Technology Corp. 69.4 2.9 99.0 0.0 0.0 (391) 0.0 0.0 1.5 0.9 0.1 4 No
Meriscreen Malaria Pf/Pan Ag MHLRPD-01 Meril Diagnostics Private Ltd. 77.0 71.4 100.0 100.0 1.3 0.0 0.0 0.0 0.5 0.0 6 No
NanoSign Malaria pf/pan Ag 3.0 RMAP10 Bioland Ltd. 92.9 97.1 100.0 100.0 0.8 0.0 0.0 0.0 0.4 0.0 4 Yes
NG-
NG-Test MALARIA Pf/Pan (pLDH) SARL NG Biotech, Z.A. 90.0 65.7 100.0 94.3 0.5 (399) 9.3 0.0 4.3 15.3 0.1 5 No
MAL-W23-001
NGB-
NG-Test MALARIA Pf/Pan (pLDH) NG Biotech 92.0 25.7 98.0 91.4 0.8 (399) 3.6 (139) 1.0 4.3 33.2 0.2 7 No
MAL-W23-005
One Step Malaria P.f/Pan Whole Blood Test W62-C Guangzhou Wondfo Biotech Co., Ltd. 77.0 14.3 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 6 No
OnSite Malaria Pf/Pan Ag Rapid Test R0113C CTK Biotech, Inc. 78.0 85.7 99.0 97.1 0.0 (398) 0.0 0.5 1.4 0.0 (207) 0.2 6 Yes
ParaHIT - Total Ver. 1.0 (Device) 55IC204-10 ARKRAY Healthcare Pvt. Ltd.n 84.7 82.4 99.0 91.2 0.3 0.0 0.5 3.0 (67) 0.0 0.1 4 Yes
ParaHIT - Total Ver. 1.0 (Dipstick) 55IC203-10 ARKRAY Healthcare Pvt. Ltd.n 76.5 61.8 100.0 94.1 0.8 0.0 0.0 1.5 0.0 0.0 4 No
Parascreen® - Rapid Test for Malaria Pan/Pf 503030025 Zephyr Biomedicals 79.0 97.1 100.0 100.0 2.3 0.0 0.0 0.0 0.0 0.0 6 Yes
QuickProfile™ Malaria Pf/Pan Test 71063 Lumiquick Diagnostics, Inc. 79.0 91.4 99.0 100.0 6.5 1.4 0.5 (199) 0.0 7.2 0.1 6 Yes
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 92.0 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.4 0.0 7 Yes
RightSign™ Malaria P.f./Pan Rapid Test Cassette IMPN-C52 Hangzhou Biotest Biotech Co. Ltd. 74.0 40.0 94.0 88.6 2.0 2.9 0.5 5.7 14.0 0.0 5 No
SD BIOLINE Malaria Ag P.f/Pan 05FK60 Standard Diagnostics Inc. 94.0 91.4 99.0 97.1 0.8 0.7 0.5 1.4 0.0 0.0 5 Yesm
Vikia® Malaria Ag Pf/Pan 412499 IMACCESS S.A.S 86.0 5.7 97.0 94.3 0.0 0.7 (139) 0.5 (199) 0.0 (69) 1.3 (235) 0.3 5 No
Pf and Pv/Pvom
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test j ITP11003-TC25 InTec Products, Inc. 92.0 97.1 98.0 100.0 1.0 0.0 1.0 1.4 (69) 0.4 0.1 7 Yes
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 75.0 100.0 98.0 100.0 1.0 (399) 0.0 (139) 1.0 (199) 1.5 (68) 0.0 (230) 0.6 7 Yes
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 85.0 91.4 99.0 100.0 0.0 0.0 0.0 0.0 (69) 0.0 (229) 0.3 7 Yes
BioTracer™ Malaria P.f/P.v Rapid Card 17412 Bio Focus Co., Ltd. 91.0 94.3 100.0 100.0 0.0 0.0 0.0 0.0 (69) 0.0 0.1 6 Yes
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 91.0 97.1 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 7 Yes
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT j RMVM-05072 Access Bio, Inc. 89.0 100.0 99.0 100.0 1.8 0.0 2.0 0.0 0.0 (231) 0.1 7 Yesm
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 93.0 88.6 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 7 Yes
Coretests® One Step Malaria Pf/Pv Ag Test Device B42-21/B42-22 Core Technology Co., Ltd. 78.0 82.9 98.0 100.0 2.8 (399) 0.0 (138) 1.0 0.0 0.0 (207) 0.5 6 Yes
EzDx™ Malaria Pv/Pf Rapid Malaria antigen detection test RK MAL 003 Advy Chemical Private Limited 76.0 77.1 100.0 100.0 1.3 1.4 0.0 1.4 3.9 0.0 6 Yes
FalciVax™ - Rapid Test for Malaria Pv/Pf 503010025 Zephyr Biomedicals 80.0 100.0 99.0 100.0 0.5 0.0 0.5 0.0 1.4 0.0 6 Yes
First Response® Malaria Ag Pf/Pv Card Test PI19FRC Premier Medical Corporation Ltd. 85.0 71.4 100.0 100.0 0.0 0.0 0.0 (199) 0.0 0.5 (207) 0.2 6 No
HiSens Malaria Ag P.f/P.v Combo Card HR3123 HBI Co., Ltd. 89.8 79.4 100.0 94.1 0.3 (391) 0.0 0.5 0.0 0.4 0.1 4 Yes

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
HiSens Malaria Ag P.f/VOM Combo Card HR3323 HBI Co., Ltd. 89.8 76.5 100.0 91.2 0.0 0.0 0.5 0.0 0.0 0.0 4 Yes
Humasis Malaria P.f/P.v Antigen Test AMFV-7025 Humasis, Co., Ltd. 92.9 100.0 100.0 100.0 0.5 0.7 0.5 1.5 1.3 0.0 4 Yes
Humasis Malaria P.f/P.v Antigen Test ANMIV-7025 Humasis Co., Ltd. 88.0 91.4 100.0 100.0 0.3 0.7 0.0 0.0 1.0 (207) 0.1 6 Yes
KHB® Malaria Ag P.f/P.v Rapid Test KH-R-07-50 Shanghai Kehua Bio-engineering Co., Ltd. 91.0 48.6 100.0 100.0 0.3 0.0 0.0 0.0 0.0 0.0 6 No
Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device 1-13-101-3 United Biotech, Inc. 60.2 0.0 92.9 26.5 0.5 0.0 (135) 3.1 (195) 1.5 0.0 (230) 0.5 4 No
Malaria Pf (HRPII)/ PV (PLDH) Antigen Detection Test Device GM006 Genomix Molecular Diagnostics Pvt. Ltd. 85.0 74.3 97.0 94.3 1.5 (391) 6.5 (138) 3.6 (195) 2.9 0.9 (232) 2.5 5 No
Malaria Pf/Pv GM002 Genomix Molecular Diagnostics Pvt.Ltd. 40.8 0.0 94.9 5.9 0.8 0.7 0.5 0.0 0.9 0.0 4 No
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 89.0 57.1 99.0 100.0 0.0 0.0 0.5 (199) 0.0 0.0 (231) 0.3 7 No
Malaria PV/PF (pLDH/HRP2) Antigen Test Inf-72 Nantong Egens Biotechnology Co., Ltd. 90.0 51.4 100.0 97.1 0.0 (395) 0.0 (137) 0.5 (198) 0.0 0.0 (203) 1.3 6 No
Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test MAT-PF/PAN-50 Bhat Bio-Tech India (P) Ltd. 84.0 62.9 100.0 100.0 27.3 (399) 5.8 (139) 87.4 (199) 4.3 (69) 3.0 (232) 0.7 5 No
 Table S2 (continued)
Panel detection scorea False positive rates (%) Total false positive
ratesb (%)
200 2000 or 5000 200 2000
parasites/µl parasites/µl parasites/µl parasites/µl Clean negative Invalid Meets
Product Product code Manufacturer samples WHO
Pf samples Pv samples Pf samples Pv samples rate Round procurement
(%)l criteria
False False False False

Pf
Pf
False positive

Pv
Pv
positive positive positive positive Plasmodium spp.

samplesc
samplesc

samplesd
samplesd
non-Pf Pf non-Pf Pf Infectioni
infectione infectionf infectiong infectionh
One Step Malaria HRP2/pLDH (P.f/P.v) Test j W056-C Guangzhou Wondfo Biotech Co., Ltd. 92.0 65.7 100.0 100.0 0.3 0.0 1.0 0.0 1.3 0.0 7 No
One Step Malaria P.F/P.V Test (Cassette) 523352 Blue Cross Bio-Medical (Beijing) Co., Ltd. 92.0 100.0 100.0 100.0 21.5 53.6 9.0 34.3 77.1 0.0 5 No
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 78.0 85.7 100.0 100.0 0.5 0.7 0.0 1.4 0.0 0.0 7 Yes
OnSite Malaria Pf/Pv Ag Rapid Test R0112C CTK Biotech, Inc. 74.0 80.0 98.0 100.0 0.0 (399) 1.4 0.0 0.0 0.0 (207) 0.2 6 No
ParaHIT®fV Rapid test for P. falciparum and P.vivax Malaria - Device 55IC402-50 ARKRAY Healthcare Pvt. Ltd.n 63.0 37.1 91.0 85.7 2.0 (399) 5.7 0.5 2.9 6.4 0.1 5 No
QuickProfile™ Malaria Pf/Pv Antigen Test j 71050 Lumiquick Diagnostics Inc. 79.0 88.6 99.0 100.0 39.8 0.0 27.5 0.0 22.9 (231) 0.1 7 No
RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PV TEST MAL-PFV-CAS/25(100) Hema Diagnostic Systems, LLC 92.9 79.4 100.0 100.0 0.0 0.7 0.0 1.5 4.3 0.0 4 Yes
RapiGEN BIOCREDIT Malaria Ag Pf/Pv (HRPII/pLDH) C40RHA25 RapiGEN Inc. 92.0 91.4 100.0 100.0 2.5 (399) 0.0 1.0 2.9 4.4 (207) 0.2 6 Yes
SD Bioline Malaria Ag P.f/P.v 05FK80 Standard Diagnostics, Inc. 92.0 94.3 100.0 100.0 0.5 0.7 0.0 0.0 1.9 0.0 6 Yesm
Rapid Test Kit for Malaria Ag Pf/Pv - Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 85.0 88.6 98.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 7 Yes
Trusty™ Malaria Antigen P.f./p.v. test A03-12-322 Artron Laboratories Inc. 88.8 38.2 99.0 100.0 13.3 27.4 (135) 16.0 (194) 19.4 (67) 32.0 (231) 0.5 4 No
Pf, Pf and Pv
85.0 100.0
SD Bioline Malaria Ag P.f/P.f/P.v k 05FK120 Standard Diagnostics, Inc. 91.4 100.0 0.0 0.0 0.5 0.0 0.0 0.0 6 Yes
(84/36) (100/98)
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 91.0 82.9p 99.0 100.0p 1.3 0.7 0.5 0.0 0.0 0.0 7 Yes
Pan only
Advantage Pan Malaria Card IR013025 J. Mitra & Co. Pvt. Ltd. 77.0 100.0 98.0 100.0 NA NA NA NA 0.4 0.0 5 Yes
AZOG hCG Malaria Detection Test Device MPT-124 AZOG, INC. 61.2 0.0 99.0 55.9 NA NA NA NA 2.2 0.2 4 No
CareStart™ Malaria PAN (pLDH) Ag RDT RMNM(U)-XXX7X Access Bio, Inc. 84.0 88.6 99.0 97.1 NA NA NA NA 0.0 0.0 5 Yesm

NA, not applicable g For combination tests, pan or Pv line, only, positive indicates a false positive
Recommended WHO
Pf, Plasmodium falciparum  non-P. falciparum infection (Round 1, n=158, Round 2, n=200; Round 3, n=198; Performance measure
Pv, Plasmodium vivax  pan, Plasmodium species procurement criteria
Pvom, Plasmodium vivax, ovale and malariae Round 4, n=196; Round 5, n=200; Round 6, n=200; Round 7, n=200) Panel detection score for Pf and Pv 200/µl samples ≥ 75%
a A sample is considered detected only if all RDTs from both lots read by the first h Pf line positive indicates a false positive P. falciparum infection (Round 1, n=40;
False-positive rates against clean-negatives < 10%
technician, at minimum specified reading time, are positive Round 2, n=80, Round 3, n=70; Round 4, n=68; Round 5, n=70; Round 6, n=70;
b The total number of times a positive result for malaria was generated when it should Round 7, n=70) Invalid rate < 5% of tests conducted
not have been i Round 1, n=168; Round 2, n=200; Round 3, n=200; Round 4, n=232; Round 5, n=236;
c Round 1, n=79; Round 2, n=100; Round 3, n=99; Round 4, n=98; Round 5, n=100; Round 6, n=208; Round 7, n=220
Round 6, n=100; Round 7, n=100 j Product resubmission, results from most recent Round of testing replace previous
d Round 1, n=20; Round 2, n=40; Round 3, n=35; Round 4, n=34; Round 5, n=35; results. Refer to Table S1.
Round 6, n=35; Round76, n=35 k PDS presented in the table is based on a positive Pf test line (either HRP2 or Pf-pLDH). The
e For combination tests, pan or Pv line, only, positive indicates a false positive results in brackets are the PDS based alone on HRP2 and Pf-pLDH test lines, respectively.
non P. falciparum infection (Round 1 n=316; Round 2, n=400; Round 3, n=396; l Round 1, n=954; Round 2, n=1240; Round 3, n=1204; Round 4, n=1192;

Round 4, n=392; Round 5, n=400); Round 6, n=400; Round 7, n=400) Round 5, n=1214 ; Round 6, n=1210; Round 7, n=1210
f Pf line positive indicates a false positive P. falciparum infection (Round 1, n=80; m Indicates a WHO prequalified product

Round 2, n=160; Round 3, n=140; Round 4, n=136; Round 5, n=140; Round 6, n=140; n ARKRAY Healthcare Pvt. Ltd. was formerly Span Diagnostics Ltd..
Round 7, n=140)     

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
Summary Rounds 1-7

15
 16
Table S3: Malaria RDT rounds 4–7 heat stability results on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µl).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Positive test results for Positive test results for Positive test results for Positive test results for
P. falciparum (Pf line) P. falciparum (Pf line) P. falciparum (Pan line) P. falciparum (Pan line)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl
Product Product Manufacturer Round
code Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C
Percentage of tests positive Percentage of tests positive Percentage of tests positive Percentage of tests positive
Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined
Pf only tests
ABON™ Malaria P.f. Rapid Test Device (Whole Blood) IMA-402 ABON Biopharm (Hangzhou) Co. Ltd 15.0 15.0 17.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test a ITP11002-TC25 InTec Products, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
Advantage P.f. Malaria Card IR016025 J. Mitra & Co. Pvt. Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 5
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
BIONOTE MALARIA P.f. Ag Rapid Test Kit RG19-11 Bionote,Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
CareStart™ Malaria HRP2 (Pf) RMOM(U)-XXX7X Access Bio, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 5
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
CareStart™ Malaria Pf (HRP2/pLDH) Ag RDT RMPM(U)-XXX7X Access Bio, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line b RMSM-05071 Access Bio, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
EzDx™ Malaria Pf Rapid Malaria antigen detection test RK MAL 008 Advy Chemical Private Limited 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
First Response® Malaria Ag P. falciparum (HRP2) Card Test I13FRC25 Premier Medical Corporation Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 5
First Response® Malaria Ag P. falciparum (HRP2) Card Test PI13FRC Premier Medical Corporation Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
FirstSign™ Malaria Pf 2100CB-25 Unimed International Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
Humasis Malaria P.f Antigen Test ANMPF-7025 Humasis Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
ICT MALARIA P.F. CASSETTE TEST a ML01 ICT INTERNATIONAL 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
IMMUNOQUICK® MALARIA falciparum 0502_K25 Biosynex 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 5
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
KHB® Malaria Ag P.f Rapid Test KH-R-06-20 Shanghai Kehua Bio-engineering Co.,Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 5
Malaria Antigen Test-Pf MAG01040 Oscar Medicare Pvt. Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
Maleriscan ® Malaria P.f Antigen Test MAT-PF-50 Bhat Bio-Tech India (Pte.) Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
One Step Malaria HRP2 (P.f) Test a W37-C Guangzhou Wondfo Biotech Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
One Step Malaria P.F Test (Cassette) 522352 Blue Cross Bio-Medical (Beijing) Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag MPHRPD-01 Meril Diagnostics Pvt. Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
OnSite Malaria Pf Ag Rapid Test R0114C CTK Biotech, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
PALUTOP + pf® 5531 ALLDIAG SA 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
Paracheck® Pf-Rapid Test for P.falciparum Malaria Device (Ver.3) 302030025 Orchid Biomedical Systems 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
Paracheck® Pf-Rapid Test for P.falciparum Malaria Dipstick (Ver.3) 302040025 Orchid Biomedical Systems 100.0 96.7 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
Parahit f® Ver 1.0 - Dipstick a 55IC103-50 ARKRAY Healthcare Pvt Ltd c 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
Parahit® f Ver 1.0 - Device a 55IC104-50 ARKRAY Healthcare Pvt Ltd c 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
MAL-PF-
Rapid 1-2-3® Hema® Cassette Malaria PF Hema Diagnostic Systems 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
CAS/25 (100)
RapiGEN BIOCREDIT Malaria Ag Pf (HRPII) C10RHA25 RapiGEN Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
RightSign® Malaria P.f. Rapid Test Cassette (Whole Blood) IMPF-C51 Hangzhou Biotest Biotech Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) b 05FK90 Standard Diagnostics Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
SD BIOLINE Malaria Ag Pf 05FK50 Standard Diagnostics, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 5
Trusty™ Malaria Antigen P.f. test A03-01-322 Artron Laboratories Inc. 100.0 100.0 56.7 100.0 100.0 100.0 NA NA NA NA NA NA 4
 Table S3 (continued)
Positive test results for Positive test results for Positive test results for Positive test results for
P. falciparum (Pf line) P. falciparum (Pf line) P. falciparum (Pan line) P. falciparum (Pan line)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl
Product Product Manufacturer Round
code Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C
Percentage of tests positive Percentage of tests positive Percentage of tests positive Percentage of tests positive
Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined
Pf and Pan
ABON™ Plus Malaria P.f/Pan Rapid Test Device (Whole Blood) IMA-T402 ABON Biopharm (Hangzhou) Co. Ltd 100.0 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 4
ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test MAGC 25 LAB-CARE Diagnostics (India) PVT. LTD. 83.3 73.3 10.0 100.0 100.0 100.0 3.3 10.0 0.0 70.0 90.0 30.0 5
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 100.0 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 100.0 100.0 100.0 7
Advanced Quality™ Rapid Malaria Test (Pf/Pan) ITP11005 InTec Products, Inc. 86.7 96.7 100.0 100.0 100.0 100.0 0.0 0.0 0.0 70.0 100.0 80.0 5
Advantage Mal Card IR221025 J. Mitra & Co. Pvt. Ltd. 0.0 0.0 0.0 100.0 100.0 100.0 0.0 0.0 0.0 70.0 100.0 80.0 5
Advantage Malaria Pan + Pf Card IR231025 J. Mitra & Co. Pvt. Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 80.0 93.3 26.7 100.0 100.0 100.0 5
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 100.0 100.0 100.0 100.0 100.0 100.0 46.7 70.0 33.3 100.0 100.0 100.0 7
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 0.0 0.0 16.7 90.0 100.0 100.0 7
Asan Easy Test® Malaria Pf/Pan Ag a AM4650-K ASAN Pharmaceutical Co., Ltd 100.0 100.0 100.0 100.0 100.0 100.0 76.7 50.0 10.0 100.0 100.0 100.0 7
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 50.0 90.0 100.0 100.0 100.0 100.0 7
ATOMORAPID™ MALARIA (PF/PAN) MMAL01 Atomo Diagnostics PTY Limited 100.0 100.0 100.0 100.0 100.0 100.0 0.0 16.7 0.0 100.0 100.0 100.0 6
AZOG Malaria pf (HRPII)/pf (LDH)/ (PAN-LDH) Antigen Detection Deviceb MFV-124F AZOG, INC. 96.7 96.7 100.0 100.0 100.0 100.0 3.3 0.0 0.0 20.0 0.0 0.0 4
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) a C32RHA25 RapiGEN Inc. 100.0 100.0 100.0 100.0 100.0 100.0 80.0 26.7 6.7 100.0 100.0 100.0 7
BIONOTE MALARIA P.f.& Pan Ag Rapid Test Kit a RG19-08 Bionote,Inc. 100.0 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 100.0 100.0 100.0 6
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 100.0 100.0 96.7 100.0 100.0 100.0 0.0 0.0 0.0 100.0 100.0 100.0 7
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 70.0 100.0 100.0 100.0 7
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT a RMLM-05071 Access Bio, Inc. 100.0 96.7 93.3 100.0 100.0 100.0 0.0 6.7 0.0 100.0 100.0 100.0 7
CareStart™ Malaria Pf/PAN (HRP2/pLDH) Ag COMBO RDT RMRM(U)-XXX7X Access Bio, Inc. 100.0 100.0 96.7 100.0 100.0 100.0 93.3 86.7 53.3 100.0 100.0 100.0 5
CareStart™ Malaria Screen RDT a RMAM-05071 Access Bio, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 7
Core Malaria Pan Pf MAL-190024 Core Diagnostics Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 26.7 80.0 83.3 100.0 100.0 100.0 4
DIAQUICK Malaria P.f/Pan Cassette Z11200CE DIALAB GmbH 100.0 100.0 96.7 100.0 100.0 100.0 0.0 0.0 0.0 100.0 100.0 80.0 5
EzDx™ Malaria Pan/Pf Rapid test detection Kit RK MAL 001 Advy Chemical Private Limited 100.0 100.0 100.0 100.0 100.0 100.0 3.3 23.3 10.0 100.0 100.0 100.0 6
First Response® Malaria Ag. pLDH/HRP2 Combo Card Test I16FRC Premier Medical Corporation Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 0.0 10.0 0.0 100.0 100.0 100.0 5
First Response® Malaria Ag. pLDH/HRP2 Combo Card Test PI16FRC Premier Medical Corporation Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 96.7 100.0 70.0 100.0 100.0 100.0 6
FirstSign™ ParaView (Pan+Pf) 2101CB-25 Unimed International Inc. 96.7 100.0 100.0 100.0 100.0 100.0 0.0 0.0 13.3 100.0 100.0 100.0 4
GenBody™Malaria Pf/Pan Ag MALAG100 GenBody Inc. 100.0 100.0 93.3 100.0 100.0 100.0 0.0 0.0 0.0 50.0 100.0 10.0 5
Genedia® Malaria P.f/Pan Ag Rapid Test 20-0146-01 Green Cross Medical Science Corp. (Korea) 100.0 100.0 43.3 100.0 100.0 100.0 3.3 0.0 13.3 0.0 0.0 0.0 5
Humasis Malaria P.f/Pan Antigen Test AMAL-7025 Humasis, Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 100.0 100.0 100.0 5
Humasis Malaria P.f/Pan Antigen Test ANMAL-7025 Humasis, Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 100.0 100.0 100.0 6
ICT MALARIA DUAL TEST a ML03 ICT INTERNATIONAL 100.0 100.0 100.0 100.0 100.0 100.0 3.3 3.3 13.3 90.0 100.0 100.0 7
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 100.0 93.3 100.0 100.0 100.0 100.0 93.3 93.3 93.3 100.0 100.0 100.0 7
Is It… Malaria Pf/Pv Device AL030 Medsource Ozone Biomedicals 100.0 100.0 96.7 100.0 100.0 100.0 93.1 96.6 36.7 100.0 100.0 90.0 6
Malaria pf (HRP II)/PAN (pLDH) Antigen Detection Test Device 1-13-101-1 United Biotech, Inc. 100.0 96.7 96.7 100.0 100.0 100.0 16.6 0.0 0.0 90.0 40.0 50.0 4
Malaria pf (pLDH) / PAN-pLDH Test Device MFV-124 AZOG, Inc. 46.7 56.7 66.7 100.0 100.0 100.0 13.3 93.3 100.0 60.0 100.0 100.0 5
Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit A03-18-322 Artron Laboratories Inc. 10.0 6.7 0.0 100.0 100.0 100.0 10.0 3.3 0.0 100.0 100.0 90.0 5
Malaria Pf/ PAN GM004 Genomix Molecular Diagnostics Pvt.Ltd. 56.7 23.3 26.7 100.0 100.0 100.0 0.0 0.0 0.0 60.0 90.0 50.0 4
Malaria Pf/Pan One Step Rapid Test RT 20222 Zhejiang Orient Gene Biotech Co., Ltd. 100.0 100.0 96.7 100.0 90.0 100.0 0.0 0.0 0.0 100.0 90.0 100.0 5
MeDiPro Malaria Ag HRP2/pLDH Combo IR-0051K Formosa Biomedical Technology Corp. 100.0 96.7 96.7 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0 4
Meriscreen Malaria Pf/Pan Ag MHLRPD-01 Meril Diagnostics Private Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 46.7 56.7 0.0 100.0 100.0 100.0 6
NanoSign Malaria pf/pan Ag 3.0 RMAP10 Bioland Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 100.0 100.0 100.0 4

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
NG-Test MALARIA Pf/Pan (pLDH) NG-MAL-W23-001 SARL NG Biotech, Z.A. 100.0 100.0 100.0 100.0 100.0 100.0 0.0 6.7 0.0 100.0 100.0 100.0 5

(continued)

Summary Rounds 1-7

17
 18
Table S3: Malaria RDT rounds 4–7 heat stability results on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µL).
Positivity rate at baseline (room temperature) and after 60 days’ incubation at 35°C and 45°C (continued)
Positive test results for Positive test results for Positive test results for Positive test results for
P. falciparum (Pf line) P. falciparum (Pf line) P. falciparum (Pan line) P. falciparum (Pan line)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl
Product Product Manufacturer Round
code Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C
Percentage of tests positive Percentage of tests positive Percentage of tests positive Percentage of tests positive
Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 100.0 100.0 100.0 100.0 100.0 100.0 53.3 86.7 66.7 100.0 100.0 100.0 7
One Step Malaria P.f/Pan Whole Blood Test W62-C Guangzhou Wondfo Biotech Co., Ltd. 100.0 100.0 96.7 100.0 100.0 100.0 0.0 0.0 0.0 90.0 100.0 70.0 6
OnSite Malaria Pf/Pan Ag Rapid Test R0113C CTK Biotech, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 0.0 6.7 0.0 100.0 100.0 100.0 6
ParaHIT - Total Ver. 1.0 (Device) 55IC204-10 Span Diagnostics Ltd. d 100.0 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 100.0 100.0 100.0 4
ParaHIT - Total Ver. 1.0 (Dipstick) 55IC203-10 Span Diagnostics Ltd. d 100.0 93.3 46.7 100.0 100.0 60.0 50.0 0.0 0.0 100.0 90.0 0.0 4
Parascreen® - Rapid test for Malaria Pan/Pf 503030025 Zephyr Biomedicals 100.0 100.0 100.0 100.0 100.0 100.0 100.0 90.0 93.3 100.0 100.0 100.0 6
QuickProfile™ Malaria Pf/Pan Test 71063 Lumiquick Diagnostics, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 100.0 96.7 100.0 100.0 100.0 100.0 6
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 100.0 100.0 100.0 100.0 100.0 100.0 0.0 0.0 33.3 100.0 100.0 100.0 7
RightSign™ Malaria P.f./Pan Rapid Test Cassette IMPN-C52 Hangzhou Biotest Biotech Co. Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 0.0 20.0 100.0 100.0 60.0 100.0 5
SD BIOLINE Malaria Ag P.f/Pan 05FK60 Standard Diagnostics Inc. 100.0 100.0 100.0 100.0 100.0 100.0 0.0 0.0 0.0 100.0 100.0 100.0 5
Vikia® Malaria Ag Pf/Pan 412499 IMACCESS S.A.S 100.0 96.7 96.7 100.0 100.0 100.0 0.0 0.0 0.0 60.0 60.0 0.0 5
Pf and Pv/Pvom
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test a ITP11003-TC25 InTec Products, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 93.3 86.7 58.6 100.0 100.0 100.0 NA NA NA NA NA NA 7
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
BioTracer™ Malaria P.f/P.v Rapid Card 17412 Bio Focus Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT a RMVM-05072 Access Bio, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
Coretests® One Step Malaria Pf/Pv Ag Test Device B42-21/B42-22 Core Technology Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
EzDx™ Malaria Pv/Pf Rapid Malaria antigen detection test RK MAL 003 Advy Chemical Private Limited 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
FalciVax™ - Rapid Test for Malaria Pv/Pf 503010025 Zephyr Biomedicals 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
First Response® Malaria Ag Pf/Pv Card Test PI19FRC Premier Medical Corporation Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
HiSens Malaria Ag P.f/P.v Combo Card HR3123 HBI Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
HiSens Malaria Ag P.f/VOM Combo Card HR3323 HBI Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
Humasis Malaria P.f/P.v Antigen Test AMFV-7025 Humasis, Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
Humasis Malaria P.f/P.v Antigen Test ANMIV-7025 Humasis, Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
KHB® Malaria Ag P.f/P.v Rapid Test KH-R-07-50 Shanghai Kehua Bio-engineering Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device 1-13-101-3 United Biotech, Inc. 100.0 100.0 100.0 90.0 100.0 100.0 NA NA NA NA NA NA 4
Malaria Pf (HRPII)/ PV (PLDH) Antigen Detection Test Device GM006 Genomix Molecular Diagnostics Pvt. Ltd. 83.3 90.0 83.3 100.0 90.0 70.0 NA NA NA NA NA NA 5
Malaria Pf/Pv GM002 Genomix Molecular Diagnostics Pvt.Ltd. 40.0 33.3 40.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
Malaria PV/PF (pLDH/HRP2) Antigen Test Inf-72 Nantong Egens Biotechnology Co., Ltd. 100.0 100.0 96.6 100.0 100.0 100.0 NA NA NA NA NA NA 6
Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test MAT-PF/PAN-50 Bhat Bio-Tech India (P) Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 5
One Step Malaria HRP2/pLDH (P.f/P.v) Test a W056-C Guangzhou Wondfo Biotech Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
One Step Malaria P.F/P.V Test (Cassette) 523352 Blue Cross Bio-Medical (Beijing) Co., Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 5
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
OnSite Malaria Pf/Pv Ag Rapid Test R0112C CTK Biotech, Inc. 100.0 100.0 90.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
ParaHIT®fV Rapid test for P. falciparum and P.vivax Malaria - Device 55IC402-50 Span Diagnostics Ltd. d 100.0 96.7 96.7 100.0 100.0 90.0 NA NA NA NA NA NA 5
QuickProfile™ Malaria Pf/Pv Antigen Test a 71050 Lumiquick Diagnostics Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
MAL-PFV-
RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PV TEST Hema Diagnostic Systems, LLC 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 4
CAS/25(100)
RapiGEN BIOCREDIT Malaria Ag Pf/Pv (HRPII/pLDH) C40RHA25 RapiGEN Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
SD Bioline Malaria Ag P.f/P.v 05FK80 Standard Diagnostics, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
 Table S3 (continued)
Positive test results for Positive test results for Positive test results for Positive test results for
P. falciparum (Pf line) P. falciparum (Pf line) P. falciparum (Pan line) P. falciparum (Pan line)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl
Product Product Manufacturer Round
code Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C
Percentage of tests positive Percentage of tests positive Percentage of tests positive Percentage of tests positive
Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined
Rapid Test Kit for Malaria Ag Pf/Pv - Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
Trusty™ Malaria Antigen P.f./p.v. test A03-12-322 Artron Laboratories Inc. 100.0 100.0 36.7 100.0 100.0 100.0 NA NA NA NA NA NA 4
Pf, Pf and Pv
SD Bioline Malaria Ag P.f/P.f/P.v b 05FK120 Standard Diagnostics, Inc. 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 7
Pan Only
Advantage Pan Malaria Card IR013025 J. Mitra & Co. Pvt. Ltd. NA NA NA NA NA NA 36.7 66.7 60.0 100.0 100.0 90.0 5
AZOG hCG Malaria Detection Test Device MPT-124 AZOG, INC. NA NA NA NA NA NA 100.0 100.0 100.0 100.0 100.0 100.0 4
CareStart™ Malaria PAN (pLDH) Ag RDT RMNM(U)-XXX7X Access Bio, Inc. NA NA NA NA NA NA 100.0 100.0 100.0 100.0 100.0 100.0 5
NA, not applicable
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species  Pvom, Plasmodium vivax, ovale and malariae
Indicates results for those products that meet all WHO recommended procurement criteria
a Product resubmission, results from most recent round of testing replace previous results. Refer to Table S1.
b Results presented in the table are based on stability of a Pf test line (either HRP2 or Pf-pLDH). Results based on stability of individual test lines is presented in the following table:
c Arkray Healthcare Pvt. Ltd. was formerly Span Diagnostics Ltd.
d Span Diagnostics Ltd. is now Arkray Healthcare Pvt. Ltd.

Positive test results for Positive test results for Positive test results for Positive test results for
P. falciparum (Pf line) P. falciparum (Pf line) P. falciparum (pan line) P. falciparum (pan line)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl
Product
Product Manufacturer Round
code Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C
Percentage of tests positive Percentage of tests positive Percentage of tests positive Percentage of tests positive
Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - (Pf(HRP2) line) 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 7
RMSM-05071 Access Bio, Inc.
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - (Pf(pLDH) line) 100.0 50.0 50.0 100.0 50.0 50.0 NA NA NA NA NA NA 7
SD Bioline Malaria Ag P.f/P.f/P.v - (PF(HRP2) line) 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
05FK120 Standard Diagnostics, Inc.
SD Bioline Malaria Ag P.f/P.f/P.v - (PF(pLDH) line) 30.0 30.0 30.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) - (PF(HRP2) line) 100.0 100.0 100.0 100.0 100.0 100.0 NA NA NA NA NA NA 6
05FK90 Standard Diagnostics Inc.
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH)- (PF(pLDH) line) 93.3 90.0 66.7 100.0 100.0 100.0 NA NA NA NA NA NA 6
AZOG Malaria pf (HRPII)/pf (LDH)/ (PAN-LDH) Antigen
96.7 96.7 100.0 100.0 100.0 100.0 3.3 0.0 0.0 20.0 0.0 0.0 4
Detection Device - (PF(HRP2) line)
MFV-124F AZOG, INC.
AZOG Malaria pf (HRPII)/pf (LDH)/ (PAN-LDH) Antigen
13.3 3.3 6.7 50.0 10.0 50.0 3.3 0.0 0.0 20.0 0.0 0.0 4
Detection Device - (PF(pLDH) line)

Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
Summary Rounds 1-7

19
 Table S4: Products evaluated during rounds 1-7 that have been removed from summary results listings
Manufacturer Product name Product code
OnSight™ - Malaria Pf Test 511-25-DB
OnSight™ - ParaQuick-2 (Pv,Pf) Malaria Test 537-25-DB
Amgenix International, Inc.
OnSight™ - PanScreen (Pan) Malaria Test 539-25-DB
OnSight™ - ParaQuick (Pan, Pf) Test 536-25DB
Abon Biopharm (Hangzhou) Co. Ltd. (Iverness Medical) ABON Malaria Pan/P.f.Rapid Test Device (whole blood) IMA-B402
Access Bio, Inc. CareStart™ Malaria/Pregnancy (HRP2/pLDH/ HCG) RRHM(U)-XXX7Xa
ParaCare Malaria HRP2/pLDH (Pf/Pv) COMBO G0161
Access Bio Ethiopia
ParaCare Malaria HRP2/pLDH (Pf/VOM) COMBO G0171
ACON Biotech (Hangzhou) Co. Ltd Surestep™ Malaria Pf/Pan Rapid Test Device (Whole Blood) IMA-T402
Acon Laboratories, Inc Malaria Plasmodium falciparum Rapid Test Device (Whole Blood) IMA-402
Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device MFV-124V
AZOG, Inc
Malaria pf (HRP II) / (PAN-LDH) Antigen Detection Test Device MFV-124R
Bhat Bio-Tech India (P) Ltd Maleriscan® Malaria Pf/Pv MAT-50
Nano Sign Malaria Pf Ag RMAF10
Bioland, Ltd
NanoSign Malaria Pf/Pv Ag RMAD10
BioNote,Inc. BIONOTE MALARIA P.f&P.v Ag Rapid Test Kit RG19-12
IMMUNOQUICK CONTACT falciparum 0519K25
Biosynex Immunoquick Malaria +4 0506_K25
IMMUNOQUICK CONTACT Malaria +4 0525K25
Core™ Malaria Pf MAL-190020
Core Diagnostics Core™ Malaria Pv/Pf Mal-190022
Core™ Malaria Pan/Pv/Pf Mal-190026
CTK Biotech, Inc. OnSite Pf Ag Rapid Test R0114C
DiaMed - A Division of Bio-Rad OptiMAL-IT 710024
Dima • Gesellschaft für Diagnostika mbH Malaria Pan test MAL-W23N-001
Diagnostics Automation/Cortez Diagnostics Inc. Malaria P.F/Vivax 172110P-25
Guangzhou Wondfo Biotech Co. Ltd. One Step Malaria P.f./Pan Whole Blood Test W56-C
HiSens Malaria Ag P.f/P.v Card HR2823
HBI Co., Ltd. HiSens Malaria Ag Pf/Pv (HRP2/pLDH) Card HR2923
HiSens Malaria Ag Pf HRP2 Card HR3023
Hexagon Malaria 58051
Human GmbH
Hexagon Malaria Combi 58024
ICT Malaria Combo ML02
ICT INTERNATIONAL
ICT MALARIA P.F. ML04
One Step Malaria Antigen Strip 820-1
IND Diagnostic Inc. IND ONE STEP MALARIA ANTIGEN P.f/Pan TEST 535-10
IND ONE STEP MALARIA ANTIGEN P.f 535-11
Innovatek Medical Inc. Quickstick Malaria Antigen Test
Inverness Medical Innovations, Inc. Binax Now Malaria IN660050
J. Mitra & Co. Pvt. Ltd. Advantage Malaria Card IR211025
Medical Diagnostech (Pty) Ltd MD Malaria Pf/Pan(pLDH) test MDMALLDH001
Medisensor Malaria HRP2/pLDH (Pf/Pv) COMBO M161
Medisensor, Inc.
Medisensor Malaria HRP2/pLDH (Pf/VOM) COMBO M171
Orgenics Ltd. (Inverness Innovations) Clearview® Malaria pLDH 70884025
Orgenics Ltd.(IS) Clearview® Malaria Dual VB20
Premier Medical Corporation Ltd. First Response® Malaria Ag pLDH I12FRC30
RapiGen inc. BIOCREDIT Malaria pf(HRP II) HR0100
Real World Diagnostics Malaria Pf/PAN TestX PROMALPFV001
ParaHIT®-f Dipstick 551C010-50/25977
ParaHIT®- f Device 551C102-50/25975
Span Diagnostics ParaHIT - Total (Device) 55IC202-10/25989
ParaHIT Pan M (dipstick) 55IC301-10
ParaHIT total (dipstick) 55IC201-10/25988
diagnosticks- Malaria (Pf) Cassette KMFC6001
diagnosticks- Malaria (Pf) Dipstick KMFD6007
diagnosticks- Malaria (Pv/Pf) Cassette KMVFC6002
SSA Diagnostics & Biotech Systems
diagnosticks MALARIA (Pan) Cassette MPNWBC1007.3
diagnosticks MALARIA (Pan/Pf) Cassette MPNFWBC1007.4
diagnosticks MALARIA (Pan/Pv/Pf) Cassette MPNVFC1007.5
SD BIOLINE Malaria Ag 05FK40
SD BIOLINE Malaria Ag Pf/ Pf/ Pv 05FK100
SD BIOLINE Malaria Ag Pf/ Pan 05Fk66
Standard Diagnostics Inc. SD BIOLINE Malaria Ag Pv 05FK70
SD BIOLINE Malaria Ag P.f/Pan 05FK63b
SD BIOLINE Malaria Ag P.f/P.v 05FK83c
SD BIOLINE Malaria Ag Pf 05FK53d
FirstSign – Malaria Pf Card Test -
FirstSign – ParaView-2 (Pv + Pf) Card Test 2102CB-25
Unimed International
FirstSign™ - PanCheck (Pan) Malaria Test 2104 CB-25
FirstSign™ - ParaView-3 (Pan+Pv+Pf) Malaria Test 2103 CB-25
Vision Malaria Pf VB01
Vision Biotech (Pty) Ltd
Clearview® Malaria Combo VB11
Zephyr Biomedicals Paramax-3 Rapid Test for Malaria Pan/Pv/Pf (device) 50320025
Pf, P. falciparum  Pv, P. vivax  Pvom, P. vivax, ovale, malariae  HRP2, histidine-rich protein 2  pLDH, Plasmodium lactate dehydrogenase
a Previously listed with product code G0221
b Previously co-listed with 05FK60 (multi-use pack), but removed because single pack format (05FK63) not evaluated at CDC
c Previously co-listed with 05FK80 (multi-use pack), but removed because single pack format (05FK83) not evaluated at CDC
d Previously co-listed with 05FK50(multi-use pack), but removed because single pack format (05FK53) not evaluated at CDC

20 Malaria Rapid Diagnostic Test Performance – Summary results of WHO product testing of malaria RDTs: rounds 1-7 (2008-2016)
2. Executive summary

Executive Summary Round 7

2.1. Introduction 2.2. The WHO product testing
WHO estimates that 3.2 billion people are at risk for malaria. programme
In 2015, there were an estimated 212 million cases (with Product testing is part of the WHO–FIND malaria RDT evalu-
an uncertainty range of 148 million to 304 million) and an ation programme, which develops methods for evaluation
estimated 429 000 deaths (with an uncertainty range of and provides data on antigen-detecting malaria RDTs. The
235 000 to 639 000). Approximately 90% of these deaths programme is a collaboration among many institutions in
occurred in sub-Saharan Africa, and just over 70% were malaria-endemic and non-endemic countries, with a global
of children under 5 years. Malaria remains endemic in 91 specimen bank and testing performed at the CDC (Fig. 2).
countries and territories, and, while parasite-based diagnosis
is increasing, national surveys between 2013 and 2015 All companies that manufacture according to ISO 13485:2003
suggest approximately 31% of suspected malaria cases in quality system standards were invited to submit tests for
sub-Saharan Africa were not confirmed with a diagnostic evaluation in the programme. The 46 products from 26
test, resulting in over-use of antimalarial drugs and poor manufacturers were evaluated with prepared blood panels
disease monitoring (1). of cultured P. falciparum parasites, patient-derived wild-
type P. falciparum and P. vivax parasites and a parasite-
WHO recommends that malaria case management be based negative panel. Observed anomalies were recorded. Thermal
on parasite diagnosis in all cases (2). The use of antigen- stability was assessed after 2 months of storage at elevated
detecting RDTs is a vital part of this strategy, forming the temperature and humidity, and a rudimentary assessment
basis for extending access to malaria diagnosis by providing of ease of use was recorded. In round 7 a new assessment
parasite-based diagnosis in areas where good-quality micros- of compliance with good practices for product labelling and
copy cannot be maintained. The data generated by the WHO instructions for use was included. As in previous rounds, RDTs
and FIND programme to evaluate and compare the perfor- are grouped in the tables and figures into those designed to
mance of commercially available malaria RDTs are guiding detect P. falciparum only, various combination tests and those
procurement decisions, which, in turn, have shifted markets that have a line only for pan-specific (or P. vivax-specific)
towards better-performing tests and helped to improve the malaria. Manufacturers submitted two lots of each product
quality of manufacture. Since 2009, these data have guided for evaluation. The 15 products that had been tested in
procurement decisions by WHO, other United Nations agencies previous rounds comprised five compulsory resubmissions
and national governments and have formed the laboratory and 10 voluntary resubmissions (Tables 1a,b).
evaluation component of the WHO prequalification process
for malaria RDTs. Meeting WHO prequalification criteria has The aim of the evaluation is to provide comparative data on
not previously been a requirement for WHO procurement; the performance of the submitted production lots of each
however, as of 1 January 2018, only those products that meet product against samples containing low (200 parasites/µL)
WHO prequalification requirements will be eligible for WHO and high densities (2000 parasites/µL) of P. falciparum or
procurement.1 This report provides the results of round 7 of P. vivax. Because the concentration of target antigens in
product testing, performed at the CDC during 2015–2016, samples with the same parasite density is variable, the process
with data on the performance of 46 products. This round for selecting the panel is adjusted to ensure that there is
adds to the evaluations of rounds 1–6 (3–8), which should no statistically significant difference in mean or median
be considered as a single evaluation, except that the results concentrations of HRP2, aldolase and pLDH antigens between
for products tested in previous rounds that were resubmitted panels used in different rounds of testing (Annex S1, Table 3).
for testing replace those reported previously. From round to
round, the evaluation panels are essentially the same (Annex WHO product testing constitutes the laboratory evaluation
S1), and the same or slightly modified testing protocols component of the WHO prequalification process for malaria
are followed. This report extends the data from previous RDTs (10), which also includes a standardized dossier review
rounds and therefore increases the number of RDTs available and a manufacturing site inspection to ensure safety, quality
for procurement for which detailed, comparative data are and performance comprehensively. WHO prequalification
available on aspects of performance relevant to field use. The of in vitro diagnostics, established in 2008, is used by all
report provides updated data on the performance of products United Nations agencies to determine the eligibility of tests
at least every 5 years, as a result of implementation of the for HIV, hepatitis B and C and syphilis for procurement and
compulsory resubmission policy. by national authorities as a complement to their regulatory
approvals. WHO prequalification will determine the eligibility
of malaria RDTs for procurement as of 1 January 2018. The
results of WHO product testing will continue to be used as
1 http://www.who.int/malaria/news/2016/rdt-procurement-criteria/ the independent laboratory evaluation component of the
en/ (accessed 8 March 2017) prequalification process.

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 21
 Compulsory resubmission was introduced in round 5. Products was – 0.4 percentage points (range, –2.5 to + 1.7%). Two of
that are due for resubmission (every 5 years) that are not the five tests had improved false-positive rates (one showed
submitted are removed from the summary results (Tables no change, and two showed increases). Overall, most of the
S2 and S3) and the online interactive database and appear differences were decreases in PDS and improvements in
only in the full round-specific product testing report. These false-positivity rates in comparison with previous testing.
products will not be eligible for WHO procurement. A product Among the voluntary resubmissions, 80% (8/10) and 75%
is also de-listed if WHO is notified by the manufacturer that (6/8) of products showed the same or better detection of
its production has been discontinued. P. falciparum and P. vivax at 200 parasites/µL, respectively.
Specifically, in tests for P. falciparum, the mean change in
PDS was +9.2 percentage points (range, –8 to +40; n = 10);
2.3. Results of the evaluation 8/10 had improved PDS. For P. vivax, the mean change in
The results (summarized in Tables 4 and 5 and Figs 9, 10, PDS was +30.7 percentage points (range, –8.6 to +65.7;
11, 14 and 15) provide a comparison of two lots of products n = 8), and 6/8 had a better PDS. The mean change in the
against a panel of parasite samples diluted to a low parasite false-positive rate on clean negatives was 1.9 percentage
density (200 parasites/µL), considered to be close to the points (range, –7.3 to + 22.9%; n = 10), while 2/10 had a
threshold that tests must detect in order to identify clinical better false-positive rate.
malaria reliably in many settings (11), and a higher parasite In combination tests, no significant correlation was found
density (2000 parasites/µL). between the changes in P. falciparum and P. vivax detection
(p = 0.7), suggesting that the changes in the detection of the
For the purposes of this report, the main measure of perfor-
two parasite species were independent.
mance is the panel detection score (PDS), the percentage
of malaria samples in a panel that give a positive result in In round 7, none of the products had very high false-positive
two RDTs per lot at the lower parasite density and a single rates when tested against clean negatives, as in round 6.
RDT per lot at the higher parasite density. Thus, it is not a These are an improvement from the high rates observed in
measure of clinical sensitivity or of the positivity rate against rounds 4 and 5. In contrast, more products reacted against
the panel but rather a combined measure of positivity rate blood samples containing specific immunological abnor-
and inter-test and inter-lot consistency. malities (and against samples containing non-Plasmodium
infectious agents), and these false-positive rates were higher
As for products evaluated in previous rounds of product
than those seen in round 5 (Tables A4.6–A4.9). The number
testing, the PDS varied, although much less variation was seen
of samples evaluated was, however, small, and the clinical
for P. falciparum-only detecting RDTs in round 7. Generally,
significance of these results is limited, although they may
products with high performance in detecting parasites have
be important in certain populations with very low parasite
low false-positive rates, good thermal stability and low
prevalence.
rates of anomalies. Overall, there is no obvious trade-off
between the PDS (or positivity rate) and the false-positive There was no notable variation among lots in round 7 (Table
rate, which are surrogates for sensitivity and specificity in A4.1); however, as previous rounds have shown variation
the field, respectively. in performance between the two lots evaluated, it is still
recommended that products be lot-tested before field use.
The basis for P. falciparum detection by combination RDTs,
particularly in samples with low parasite density, is predomi- The P. falciparum HRP2 test lines in the majority of products
nantly detection of HRP2 and not pLDH. In other words, it is showed good heat (thermal) stability after 2 months’ storage
mainly the HRP2 test band that reacts with P. falciparum- at 45°C and 75% humidity; however, Pf-pLDH test lines
containing samples, probably reflecting poorer affinity of showed variable baseline performance and deterioration after
the monoclonal pLDH antibodies on the pLDH test band and incubation at 45°C. For many products, pan-pLDH perfor-
not HRP2-persistent antigenaemia, as all samples are known mance at baseline and after heat stress for detection of the
to contain P. falciparum (and pLDH). Therefore, when using P. falciparum isolate was poor, and it was nearly universally
HRP2 and pan-pLDH (or Pf-pLDH) combination products in poor against low-parasite-density samples, making it difficult
the field, it is important to remember that the presence of to assess true stability. As in round 6, products were assessed
an HRP2 band combined with the absence of a pLDH band for heat stability against a wild-type P. vivax sample. While
may reflect the lower sensitivity of the pLDH-detecting band most of the products performed well, with high positivity
in low-density samples and not persistent antigenaemia or rates after 2 months’ storage at 45°C and 75% humidity,
successful treatment. others showed some drop in performance after storage,
with little difference between pan-pLDH and P. vivax pLDH
In round 7, the results for five products submitted for in test line stability.
compulsory retesting showed an average PDS decrease of
3.5 percentage points as compared to the previous evalu- The frequencies of anomalies that can interfere with test
ation round, for detection of P. falciparum (range, –16 to interpretation were recorded. In round 7, 33 of the 46 prod-
+7; 2/5 had a better PDS). Only two of these tests also ucts had one to five different types of anomaly (Annex S2,
targeted P. vivax at 200 parasites/µL; the mean change in Table 8, Fig. 30). Incomplete clearing and red background (not
PDS was – 42.9 percentage points (range, –91 to +5). The obscuring the test lines) were the most common anomalies,
mean change in the false-positive rate of clean negatives seen in 48% and 24% of products, respectively. Incomplete

22 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
migration, failed migration and a red background obscuring
the test lines were the next most common anomalies, in
2.4. Use of the results
15%, 11% and 11% of products, respectively. Most of the Box 3 lists WHO’s current minimum criteria for selecting
products with anomalies (31/33) had anomalies in < 1% of RDTs. With the upcoming transition to WHO prequalification
the tests, while two products had anomalies in 1.4% of tests as a requirement for malaria RDT procurement, the findings

Executive Summary Round 7

(Table 8). This rate is far lower than in round 6, in which all from dossiers and site inspections will also be considered;
products had one to six anomalies, and approximately half however, the performance requirements will remain the same.
had a frequency > 2%. The results in Tables S2, S3 and 5 are colour-coded to reflect
achievement of these requirements, as well as current WHO
The clinical sensitivity of an RDT, i.e. the proportion of known prequalification status (indicated in Table S2). A web-based
cases of the disease with a positive test, is highly dependent tool maintained by FIND allows filtering of product testing
on local conditions, including the parasite density in the results by various parameters to assist in selecting products
target population; it therefore varies in populations with with the performance characteristics most suitable for a
different levels of transmission. The comparative performance country’s health programme (15). This online database has
between RDTs shown in this report give an indication of been updated to allow filtering of results by RDT procedural
which products are likely to be more sensitive in the field, characteristics, such as blood volume requirements, number of
particularly for populations with low-density infections. buffer drops and time to result. This grouping, also indicated
In general, as the malaria prevalence in countries falls and in Annex 1, will allow use of the same or similar protocols
they even move towards malaria elimination, detection of to identify products, so that, when product replacement is
low parasite densities will become increasingly important in required, another product with the same or similar protocol
case management. As the PDS at 2000 parasites/µL indicates, may be selected. Use of similar products may reduce the need
the sensitivity of many of these products will be similar in for user retraining and also reduce user error.
populations with higher parasite densities, although a subset
of any population will include vulnerable individuals who may The results of product testing are reported by product, with
develop illness at low parasite densities (e.g. young children, the product name and code. The same RDT may be sold in a
pregnant women, people well protected by bed nets) and variety of configurations, such as single or multi-kits, different
must always be taken into account when interpreting RDT numbers of tests per box, with or without certain accessories;
results. For areas where significant non-expression of HRP2 and they are assigned a distinct product code on this basis.
is known, the results in this report for HRP2-detecting tests The reports gives the precise name and product code provided
should not be considered to predict sensitivity in the field. by the manufacturer for testing. Procurers should contact
Only tests targeting P. falciparum by detection of pLDH or the manufacturer for a list of product configurations prior
aldolase should be considered. to purchase.

Heat stability (summarized in Tables 6a and 6b) is vital to Annex S3 outlines a step-by-step approach to selecting an
maintaining the sensitivity of a test in the field. For procure- RDT, taking into consideration local conditions of malaria
ment, therefore, the stability results should be used to ensure transmission and illness (e.g. Plasmodium spp., target antigen,
that products to be used in areas with high temperatures parasite density, climate) and other important considera-
during transport and storage have demonstrated good tions, such as ease of use in the field and lot testing. RDTs
stability in the product testing programme. The requirements must not be procured without preparation for proper use,
vary by country; for example, if tests are to be used in areas including supply chain management and training in test
where the temperature rarely rises above 30°C, stability at use and disposal and in patient management in response
high temperatures is less important. to results. Comprehensive guidance on several aspects
of procurement can be found in Recommended selection
The requirements for ease of use depend on the extent of criteria for procurement of malaria rapid diagnostic tests
training and the work environment of users. Particularly in (16), published as a WHO information note in 2016,1 and
primary health care settings, the simpler the test, the easier guidance on implementation in Universal access to malaria
it should be to avoid errors in preparation and interpretation. diagnosis (17).
In round 7, for the first time, adherence to a list of recom-
mendations on instructions for use and product labelling was
assessed (Fig. 31-38). Products generally scored well in this
assessment for labelling of the main device and labelling of
the device packaging and of the primary product box, with
some exceptions, especially in warnings and precautions.
The scores for adherence to recommendations on labelling
of buffer bottles and other accessories were lower. The
instructions for use were highly variable, with some impor-
tant omissions, particularly on laboratory safety, product
performance and interpretation.

1 http://www.who.int/malaria/publications/atoz/rdt-selection-criteria.pdf

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 23
 3. Background

During the past decade, new opportunities for the control methods, analysis and reporting (17–25). In general, diagnostic
of malaria have emerged, including use of long-lasting testing by microscopy or RDT to a level of 200 parasites/µL
insecticidal nets, indoor residual spraying of insecticides will reliably detect nearly all clinically relevant infections in
and artemisinin-based combination therapy. These have malaria-endemic areas (11).
been shown to reduce the burden of malaria infection in
countries where they are adequately implemented. Therefore, The number of RDTs available on the market grew rapidly
the proportion of febrile episodes attributable to malaria is after their introduction in the late 1990s; sales reported by
likely to decrease substantially. 41 manufacturers showed a peak of 320 million tests sold
in 2013. Since 2013, there has been a global decline, due to
Despite WHO’s recommendation for a parasitologically decreasing sales in Asia, although sales in Africa have risen
confirmed diagnosis of malaria infection before treatment every year since 2008 (1). Regulatory control of diagnostics
in all cases (2), diagnoses are still often made on clinical is, however, often weak, and procurement agencies have
grounds (11); however, in many endemic areas, malaria had considerable difficulty in selecting appropriate RDTs
accounts for a minority of cases of “malaria-like” febrile and ensuring their quality. In view of the inconsistency in
illness. Microscopy has been the cornerstone of diagnosis the results of field studies and the inherent difficulties in
and is recommended for malaria diagnosis when its quality assessing large numbers of products in a standardized way
can be maintained; however, the need for trained personnel in field trials, WHO and partners embarked on a programme
and adequate reagents and equipment limits its availability in 2002 to evaluate RDTs for malaria, in order to ensure
and accessibility in malaria-endemic areas. Rapid, accu- standardized assessment of performance and to guide
rate, accessible diagnostic tools are increasingly required procurement decisions and regulatory mechanisms. Between
as programmes extend parasite-based diagnosis and the 2003 and mid-2012, the programme was managed by WHO
prevalence of malaria decreases. RDTs to detect Plasmodium- and TDR in partnership with FIND. After TDR withdrew its
specific antigens (proteins) in whole blood of infected people involvement in 2012, the WHO Global Malaria Programme
are an attractive alternative to microscopy. The currently assumed a coordinating role. A steering committee oversees
available RDTs come in various formats (dipstick, cassette or the development of and modifications to standard operating
hybrids) and contain antibodies bound to specific antigens, procedures (26, 27). A network of specimen collection sites
such as HRP2 specific to P. falciparum, pan-specific and has been established to provide specimens for a global bank
species-specific pLDH or aldolase specific to all the major at the CDC and to facilitate local quality control (Fig. 2).
Plasmodium species most relevant to human health (P. falci-
parum, P. vivax, P. malariae, P. ovale) (Fig. 1). The reports of the previous six rounds of product testing
have been released annually since 2009 (3–8). This seventh
To be widely useful, an RDT must be highly sensitive to ensure report adds data on the performance of 29 new products and
detection of all clinically significant malaria infections, highly updated data on 17 resubmitted RDTs. Testing for round 7 was
specific to allow monitoring of low malaria prevalence and conducted against an evaluation panel with characteristics
appropriate management of non-malarial fevers and highly similar to those of previous panels in terms of overall antigen
stable to allow transport and storage in ambient conditions concentration, parasite origin and parasite-negative blood
in malaria-endemic areas. Published field trials of RDTs samples (Annex S1). Most panel samples were retained from
show highly variable performance, probably due to poor previous rounds, with 19 of 100 P. falciparum, 5 of 35 P. vivax
manufacturing quality, incorrect storage and handling, poor and 17 of 100 negative samples replaced (new) in round 7.
preparation and interpretation, and sometimes poor study

4. Objective

The objective of the programme is to evaluate malaria RDTs

for performance in order to guide procurement of RDTs for
use in the field in malaria-endemic countries.

24 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Figure 1: Mode of action of antigen-detecting malaria RDTs
Control line
a (bound Ab)*
Test line
Lysing agent
and labelled Ab
(bound Ab)* Mode of action of common malaria RDT format:
Bound Ab
(a) Dye-labelled antibody (Ab), specific for the target

Executive Summary Round 7

antigen, is present on the lower end of the nitrocellulose
Nitrocellulose strip strip or in a well provided with the strip. Antibody, also
Free labelled
*Not normally visible
Ab specific for the target antigen, is bound to the strip in a
Buffer/ thin (test) line, and either antibody specific for the labeled
flushing agent
antibody, or antigen (Ag), is bound at the control line.
b
Parasitized
Parasite Ag blood (b) Blood and buffer, which have been placed on the strip
captured by or in the well, are mixed with the labelled antibody and
labelled Ab
are drawn up the strip across the lines of bound antibody.
Blood and labelled Ab flushed along strip (c) If antigen is present, some labelled antibody will be
c
trapped on the test line. Other labelled antibody is trapped
on the control line.

Captured Captured
Ag–labelled labelled Ab
Labelled Ab–Ag Labelled Ab Ab complex
complex captured captured by
by bound Ab of bound Ab of
test band control band

Malaria, countries
Figure 2: Network of specimen collection, or areas at riskand
characterization of transmission, 2009
testing sites

HTD

CDC

DRM RITM
UCAD IPB EHNRI IPC
CIDEIM UL KEMRI
IMT IHRDC
IPM

QIMR

Collection and testing site Countries or areas where malaria transmission occurs
Countries or areas with limited risk of malaria transmission
Specimen characterization
No malaria
Global specimen bank Source: © WHO 2010. All rights reserved.
This map is intended as a visual aid only and not as a definitive source of information about malaria endemicity.

CDC, Centers for Disease Control and Prevention (Atlanta, United States of America); CIDEIM, Centro Internacional de Entrenamiento
y Investigaciones Médicas (Cali, Colombia); DMR, Experimental Medicine Research Division (Department of Medical Research, Yangon,
Myanmar); EHNRI, Ethiopian Health and Nutrition Research Institute (Addis Ababa, Ethiopia); HTD, Hospital for Tropical Diseases
(London, United Kingdom); IHRDC, Ifakara Health Research and Development Center (Bagamoyo, United Republic of Tanzania); IMT,
Instituto de Medicina Tropical (Universidad Peruana Cayetano Heredia, Lima, Peru); IPB, Institut Pasteur de Bangui (Bangui, Central
African Republic); IPC, Institut Pasteur du Cambodge (Phnom Penh, Cambodia); IPM, Institut Pasteur de Madagascar (Antananarivo,
Madagascar); KEMRI, Kenya Medical Research Institute (Kisumu, Kenya); QIMR, Queensland Institute of Medical Research (Brisbane,
Australia); RITM, Research Institute of Tropical Medicine (Manila, Philippines); UCAD, Université Cheikh Anta DIOP (Dakar, Senegal); UL,
University of Lagos (Lagos, Nigeria).

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 25
 5. Materials and methods

5.1. Test selection compilation of the results of all previous rounds of testing.

This rule was introduced in round 5 to ensure that all prod-
In July 2015, the WHO–FIND malaria RDT evaluation ucts were retested < 5 years after the primary submission.
programme issued a call for expressions of interest to Other standard requirements included valid ISO 13485:2003
manufacturers of malaria RDTs with information on the certification of all manufacturing sites, sufficient quantities of
requirements for submission of a product to round 7 and products (1100 tests from each of two lots1), compliance with
the conditions for participation in the evaluation programme
(29). Manufacturers of products that had not been retested
since round 3 were informed they must resubmit these 1 Manufacturers were requested to supply an additional 500 RDTs
products; otherwise, the performance characteristics would per lot voluntarily to support the WHO-FIND evaluation of malaria
be removed from the summary results document, which is a recombinant antigens.

Table 1a: Manufacturers and products accepted into round 7 of WHO malaria RDT product testing programme
Manufacturer Product name Product codea Target antigen(s)
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDTc RMVM-05072 V(pLDH), HRP2
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line RMSM-05071 F(pLDH), HRP2
Access Bio, Inc.
CareStart™ Malaria Screen RDTb RMAM-05071 pan(pLDH), HRP2/F(pLDH)
CareStart™ Malaria Pf/PAN (pLDH) Ag RDTb RMLM-05071 pan(PLDH), F(pLDH)
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 HRP2
Access Bio Ethiopia
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 V(pLDH), HRP2
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 pan(pLDH), HRP2
Advy Chemical Private Limited
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 HRP2
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 pan(pLDH), HRP2
Alere Medical Private Limited
Rapid Test Kit for Malaria Ag Pf/Pv- Alere Trueline Malaria Ag Pf/Pv 11108191040 V(pLDH), HRP2
PALUTOP +4 optima® 5499 pan(pLDH), V(pLDH), HRP2
ALLDIAG SA
PALUTOP + pf® 5531 HRP2
Parahit® f Ver 1.0 - Deviceb 55IC104-50 HRP2
ARKRAY Healthcare Pvt Ltd
Parahit f® Ver 1.0 - Dipstickb 55IC103-50 HRP2
ASAN Pharmaceutical Co., Ltd Asan Easy Test® Malaria Pf/Pan Agc AM4650-K pan(pLDH), HRP2
Aspen® Malaria Ag Pf/Pv AS0060 V(pLDH), HRP2
Aspen Laboratories Pvt. Ltd.
Aspen® Malaria Ag Pf AS0015 HRP2
BioTracer™ Malaria P.f Rapid Card 17912 HRP2
Bio Focus Co., Ltd.
BioTracer™ Malaria P.f/PAN Rapid Cardc 17012 pan(pLDH), HRP2
Biosynex® Malaria Pf/Pv 0581_K25 V(pLDH), HRP2
Biosynex
Biosynex® Malaria Pf/Pan 0584_K25 pan(pLDH), HRP2
DIALAB DIAQUICK Malaria P.f. Cassette W06200 HRP2
One Step Malaria HRP2 (P.f) Testc W37-C HRP2
Guangzhou Wondfo Biotech Co., Ltd.
One Step Malaria HRP2/pLDH (P.f/P.v) Testc W056-C V(pLDH), HRP2
Hangzhou AllTest Biotech Co. Ltd. AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Aldolase, HRP2
Hema Diagnostic Systems Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 HRP2, pan(pLDH)
ICT MALARIA DUAL TESTc ML03 HRP2, pan(pLDH)
ICT INTERNATIONAL
ICT MALARIA P.F. CASSETTE TESTb ML01 HRP2
ADVANCED QUALITY ™ ONE STEP Malaria (p.f) Testc ITP11002-TC25 HRP2
InTec Products, Inc.
ADVANCED QUALITY ™ ONE STEP Malaria (p.f/p.v.) Tri-line Testc ITP11003-TC25 V(pLDH), HRP2
Lumiquick Diagnostics Inc. QuickProfile™ Malaria Pf/Pv Antigen Testc 71050 V(pLDH), HRP2
Medical Diagnostech (Pty) Ltd GMD Malaria Pf test GMDMALPF001 HRP2
Real World Diagnostics Malaria Pf/PAN Test PROMALPFV001 HRP2, V(pLDH)
Medsource Ozone Biomedicals Pvt. Ltd. Is It... Malaria Pf PAN MPFPAN050 pan(pLDH), HRP2
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 V(pLDH), HRP2
Meril Diagnostics Pvt. Ltd.
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag MPHRPD-01 HRP2

26 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Table 1a: (continued)
Manufacturer Product name Product codea Target antigen(s)
NG Biotech NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 HRP2, pan(pLDH)
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH)c C32RHA25 pan(pLDH), HRP2
RapiGEN Inc.
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 V(pLDH), F(pLDH)
Shanghai Kehua Bio-engineering Co., Ltd. KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C HRP2
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 HRP2/F(pLDH)
Standard Diagnostics, Inc.d
Alere™ Malaria Ag P.f 05FK140-40-0 HRP2
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 HRP2
WELLS BIO, INC
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 V(pLDH), HRP2
Malaria Pf Rapid Test GCMAL(pf)-402a HRP2
Zhejiang Orient Gene Biotech Co., Ltd.
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a HRP2, V(pLDH)
pLDH, Plasmodium lactate dehydrogenase; HRP2, histidine rich protein 2; V, P. vivax; F, P. falciparum
a The product code corresponds to a specific configuration of the RDT, kit components and accessories. Therefore, changes to this configuration including the quantity
of tests, the contents or the manufacturing site are denoted by a different product code. Often this involves the end portion of the product code; however, the
manufacturer should be contacted for full details.
b Indicates previously submitted products which were submitted for compulsory restesting in round 7.
c Indicates products which have previously been submitted and were voluntarily resubmitted in round 7.
d An Alere company

Methods
Table 1b: Products due for compulsory resubmission in round 7
Participation
Manufacturer Product name Product Code
in round 7a
ABON Biopharm (Hangzhou) Co. Ltd ABON Malaria Pan/P.f. Rapid Test Device (Whole Blood) IMA-B402 No
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071b Yes
Access Bio, Inc. CareStart™ Malaria/Pregnancy (HRP2/pLDH/ HCG) RRHM(U)-XXX7Xc No
CareStart™ Malaria Screen RDT RMAM-05071d Yes
ACON Biotech (Hangzhou) Co. Ltd Surestep™ Malaria Pf/Pan Rapid Test Device (Whole Blood) IMA-T402 No
Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device MFV-124V No
AZOG, Inc
Malaria pf (HRP II) / (PAN-LDH) Antigen Detection Test Device MFV-124R No
Nano Sign Malaria Pf Ag RMAF10 No
Bioland, Ltd
NanoSign Malaria Pf/Pv Ag RMAD10 No
BioNote,Inc. BIONOTE MALARIA P.f/P.v Ag Rapid Test Kit RG19-12 No
IMMUNOQUICK CONTACT falciparum 0519K25 No
Biosynex
IMMUNOQUICK CONTACT MALARIA +4 0525K25 No
Core™ Malaria Pf MAL-190020 No
Core Diagnostics Core™ Malaria Pv/Pf Mal-190022 No
Core™ Malaria Pan/Pv/Pf Mal-190026 No
CTK Biotech, Inc. OnSite Pf Ag Rapid Test R0114C No
DiaMed - A Division of Bio-Rad OptiMAL-IT 710024 No
Dima • Gesellschaft für Diagnostika mbH Malaria Pan test MAL-W23N-001 No
ICT International ICT Diagnostics Malaria P.f ML01 Yes
J. Mitra & Co. Pvt. Ltd. Advantage Malaria Card IR211025 No
Orgenics Ltd. Clearview® Malaria pLDH 70884025 No
Standard Diagnostics Inc. SD BIOLINE Malaria Ag 05FK40 No
ParaHIT® - f (Device) 55IC102-10 Yes
Span Diagnotics Ltd.e
ParaHIT® - f (Dipstick) 55IC101-10 Yes
diagnosticks MALARIA (Pan) Cassette MPNWBC1007.3 No
SSA Diagnostics & Biotech Systems diagnosticks MALARIA (Pan/Pf) Cassette MPNFWBC1007.4 No
diagnosticks MALARIA (Pan/Pv/Pf) Cassette MPNVFC1007.5 No
Clearview® Malaria Combo VB11 No
Vision Biotech (Pty) Ltd.
Clearview® Malaria Pf VB01 No
Guangzhou Wondfo Biotech Co. Ltd. One Step Malaria P.f./Pan Whole Blood Test W56-C No
a The results of the first testing of the products in this list that were not retested in round 7 have been removed from tables S2 and S3 and figs S1 and S2 and are listed in table S4.
b Previously listed with product code G0121
c Previously listed with product code G0221
d Previously listed with product code G0231
e Currently listed with product codes 55IC104-50 and 55IC103-50. Span Diagnostics is now ARKRAY Healthcare Pvt.Ltd.

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 27
 the product definition1, deadlines for document submission
and payment of fees.
5.2. The product testing protocol
The testing process is outlined in Fig. 3 and in the Methods
Twenty-seven manufacturers, proposing 45 products, manual for product testing of malaria rapid diagnostic tests,
responded to the call, and the products went forward for version 6 (28). In brief, RDTs from each of two lots of each
testing. A further product from one manufacturer was product were evaluated against a panel of parasite-positive
exceptionally accepted as a late entry, directly into phase and parasite-negative cryopreserved blood samples. Both lots
2, because of the urgent need for pf-pLDH-based RDTs in were also tested for heat (thermal) stability, evaluated after
areas with a high prevalence of HRP2 deletions. Overall, 46 2 months’ storage at room temperature (21–24°C), 35°C and
products from 27 manufacturers were tested in round 7 45°C. A description of the ease of use of the products was
(Table 1a). Catalogue numbers and verification with manu- completed on a standard form, and common anomalies were
facturers showed that 15 of the 46 products (33%) had been recorded. Evaluation of adherence to recommendations on
submitted previously to one or more rounds, including five instructions for use and labelling was introduced in round 7.
(11%) scheduled for compulsory resubmission (Table 1b). All Products were assessed against a list of preferred and required
45 products met the minimum performance requirements2 in recommendations on the scope, format and terms used in the
the initial evaluation against the P. falciparum culture-derived instructions for use and on the labelling of the box, the test
panel (phase 1) and were therefore evaluated fully in phase device, its primary packaging, buffer bottle, other accessories.
2, with the additional product.
The testing and all the results were monitored by the WHO–
Of the 46 products that were fully evaluated, 19 are designed FIND steering committee, and manufacturers were given
to detect P. falciparum alone, 13 to detect and differentiate 30 days to comment on the results for individual products
P. falciparum from non-P. falciparum malaria, 13 to differ- before publication.
entiate P. falciparum from P. vivax and one to detect and
differentiate P. falciparum, P. vivax and other Plasmodium
species. Of these products, five detected P. falciparum pLDH. 5.3. Evaluation panels
Three products had separate Pf-pLDH detecting lines and
RDTs were evaluated against three panels:
two combined P. falciparum pLDH with HRP2 on the same
line. Annexes 1 and 2 give a comprehensive overview of the • P. falciparum culture lines (includes a subset, “manufac-
product characteristics. turer’s panel”) at low (200 parasites/µL) and high parasite
density (2000 parasites/µL);
• wild-type Plasmodium species (P. falciparum, P. vivax)
from naturally infected humans diluted with parasite-
1 A working definition of a product can be found in Annex 2 (http:// negative samples to low (200 parasites/µL) and high
www.who.int/malaria/news/2015/EOI-letter-to-manufacturers-Rd7-
annex-2jul2015.pdf?ua=1, accessed 8 March 2017).
2 PDS > 80% against high-density (2000 parasites/µL) P. falciparum
in culture

Figure 3: Overview of malaria RDT product testing

RDT product testing flow chart

Panel detection score Heat stability Ease-of-use description Labelling and instruction for use
and false-positive rate

Test RDTs against high Select RDTs from 2 differents lots

and low density samples Blood safety Labelling Instruction for use
of phase 1 panel

Place in Place in Initial test (room Total time

a 35°C a 45°C temperature) • Box • Layout
to obtain result
Proceed to test RDTs incubator incubator 200, 2000 p/µL • Cassette packaging • Product information
against phase 2 panel, Number • Cassette • Intended use
if pass phase 1 of timed steps • Buffer container • Warnings and precautions
Store for 2 months at 75% humidity Quality of • Accessories • Materials
In each case, the instructions • Storage and stability
read each result with: • Procedure
• Limitations
Remove and allow RDTs Additional information Completed
• format • Performance specifications
to reach room temperature assessment
Technician Technician • blood transfer method • Bibliography
forms
1 2 • items included • Contact manufacturer
in package
Prepare RDTs Prepare RDTs • language
with a 200 p/µL with a 2000 p/µL • anomalies
sample sample

Record results Record results Record results

28 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 parasite density (20001 parasites/µL), all samples prepared culture bank and diluted in O-positive blood from donors
from isolates that express HRP2; and in the USA (28).
• a parasite-negative panel (“clean” samples and disease-
specific or blood factor-specific samples). Wild-type parasite panel
The parasite-positive wild-type (clinical) panel consisted of
An overview of sample collection and characterization is
samples from 100 cases of P. falciparum and 35 cases of
given in the methods manuals prepared for this purpose (27,
P. vivax malaria, from 11 collection sites in Africa, Asia and
28). Characterization results for each round are available in
South America (Figs 2, 4a and 4b). Samples were collected
the reports of previous rounds (3-8). Each panel specimen
from febrile patients and processed by standard methods
was characterized for:
designed to preserve the target antigen concentration
• species, by duplicate microscopy (two microscopists) (27). After dilution and cryopreservation, the samples were
and confirmation of mono-species infection by nested transferred to the global bank (WHO specimen bank) at CDC
polymerase chain reaction (PCR); for further characterization. The concentrations of sample
• antigen concentration, by quantitative ELISA for HRP2, antigens (HRP2, pLDH, aldolase) determined by quantitative
pLDH and aldolase; and ELISA are shown in Table 3. The results are based on 98
P. falciparum samples for pLDH, 99 P. falciparum samples
• the absence of malaria parasites by nested PCR and
for HRP2 and 100 for aldolase, 34 P. vivax samples for pLDH
confirmatory testing for other diseases in the case of
and 35 P. vivax samples for aldolase. This panel is closely
parasite-negative samples.
comparable to those of previous rounds (Annex S1).
Some of the P. falciparum samples in the global specimen

Methods
bank were also characterized according to HRP2 sequence by Negative blood sample panel
PCR amplification and sequencing. This was not performed
The negative panel consisted of 52 “clean” parasite-negative
on samples collected after 2009, as accumulated evidence
samples from donor-derived blood obtained in banks or
indicates that HRP2 variation has no significant effect on
from volunteers in non-endemic (USA) and endemic areas
RDT sensitivity (30). The geographical origin of all samples
(Cambodia, Kenya, Madagascar, the Philippines and Senegal)
was recorded.
that had been confirmed to be malaria-negative by micros-
Panel composition copy and PCR. The negative sample panel also contained
48 parasite-negative samples from donors with diseases
P. falciparum-cultured parasites panel that might be used in the differential diagnoses of malaria,
The programme selected culture-adapted strains of P. falci- that contained blood factors known to be common in the
parum from various geographical locations, including 13 community or that could result in false-positive reactions in
strains with type B HRP2 sequence, five with type A and two immunochromatographic tests (Table 2). All negative control
with type C (30). All specimens were derived from the CDC samples were confirmed to be free of Plasmodium parasites
by nested-PCR.
1 Three (3%) of the 100 high-parasite-density P. falciparum dilution
samples contained 5000 rather than 2000 parasites/µL.

Figure 4a: Origin of phase 2 P. falciparum wild-type Figure 4b: Origin of phase 2 P. vivax
(clinical) samples (n=100) wild-type (clinical) samples (n=35)
50
18
45
40
35
No. of samples

12
No. of samples

30
25
20
15 6

10
5
0 0
ru

ia

bia

ia

es
ia
ria

ia

ru

bia

al

es

ya

ia

r
c
nz c

pu l

ma
Re tra
bli
Ta bli

od

iop
an
od

eg

iop

pin
Pe
Pe

pin

n
ge

lom
lom

Ke
of Repu

an
an en

mb
n
mb

Eth
Eth
Ni

ilip
ilip
Se

My
C

Co
Co

Ca
Ca

Ph
Ph
d
ite

ric
Un

Af

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 29
 Table 2: Characteristics of Plasmodium spp. negative samples of a set of lot 1 of all products was completed, then a set
of lot 2 was tested, until both lots of all products had been
Nature of negative samplea No.
tested against all panel samples.
Clean-negativeb 52
Phase 1. A screening step is used to allow selection of RDTs
Anti-nuclear antibody positive (sera) 12 that meet the minimal quality requirements. Products from
two lots were evaluated against a panel of 20 culture-derived
Anti-mouse antibody positive (plasma) 3
P. falciparum samples at high (2000 parasites/µL) and low
Rheumatoid factor positive (whole blood and sera) 6 (200 parasites/µL) parasite density, and against 20 clean
negative samples. To progress to the full evaluation (phase 2),
Rapid plasma reagin positive (sera) 6 a product evaluated in phase 1 must achieve a minimum PDS
Chagas' disease antibody positive (plasma) 2 of 80% against the samples containing 2000 parasites/µL
and <50% false positive rate against clean negative samples.
Dengue antibody positive (whole blood sera) 7
Phase 2. Products from two lots are evaluated against a
Leishmaniasis antibody positive (sera) 4 panel of diluted clinical blood samples containing wild-type
parasites and a parasite-negative panel, evaluated for heat
Schistosomiasis antibody positive (whole blood and sera) 8
(thermal) stability and assessed for ease of use. Because
a Whole blood unless indicated. Sera and plasma samples were reconstituted the number of aliquots were smaller, fewer replicate RDTs
packed cells
b Healthy volunteers with no known current illness or blood abnormality were performed.
• Performance assessment: The mixed parasite-positive and
parasite-negative panel comprised 100 P. falciparum, 35
5.4. Product registration P. vivax at two parasite densities (200 parasites/µL and
2000 parasites/µL 2) and 100 parasite-negative samples.
Receipt of each shipment of RDTs at the CDC was recorded
in a dedicated RDT register. Temperature monitoring devices • Evaluation of heat stability for P. falciparum-detecting
were offered to manufacturers free of charge to accompany products: 15 RDTs from each of two lots were tested
RDT shipments to the CDC. All RDTs were stored at room against a single culture-derived P. falciparum isolate
temperature (21–24°C) immediately, and temperature moni- (Nigeria XII strain, P. falciparum HRP2 sequence type B)
tors were labelled with the date of receipt and forwarded for with a typical antigen concentration3 at 200 parasites/µL,
data extraction and analysis, when applicable. five RDTs from each lot against P. falciparum Nigeria XII
strain at 2000 parasites/µL and four RDTs from each
lot against a negative sample, which were all tested at
5.5. Specimen panel registration baseline and after RDTs were maintained for 60 days
at room temperature (< 25°C), 35°C and 45°C, at 75%
All panel specimens were assigned unique identification
humidity.
numbers at the collection sites and stored in aliquots of
50 µL at –70°C until testing. All data pertaining to specimen Evaluation of heat stability for P. vivax-detecting prod-
identification, storage location and characterization are ucts: Four RDTs from each of the two lots were tested
stored in a secure, dedicated database. against a single wild-type P. vivax sample4 (from Ethiopia)
at 200 parasites/µL, two RDTs from each lot against
P. vivax at 2000 parasites/µL and four RDTs from each lot
5.6. Test phases against a negative sample, at baseline and after RDTs were
The evaluation is divided into two phases. Each lot of RDTs
was evaluated independently. Lots 1 and 2 of each product 2 Three (3%) of the 100 P. falciparum high parasite density dilution
were tested alternately against defined sample sets1, testing samples contained 5000 parasites/µL rather than 2000.
3 The P. falciparum sample had 18.8 ng/mL of HRP2, 21.1 ng/mL of
1 A sample set usually consists of 13 P. falciparum specimens and 5 pLDH and 0.49 ng/mL of aldolase.
P. vivax specimens at 200 parasites/µL and 2000 parasites/µL and 4 The P. vivax sample had 143.9 ng/mL of pLDH and 44.4 ng/mL of
13 malaria-negative samples. aldolase.

Table 3: Malaria antigen concentrations (ng/mL) in round 7 wild-type, low parasite density (200 parasites/µL) samples
pLDH HRP2 Aldolase
P. falciparum P. vivax P. falciparum P. falciparum P. vivax
Mean 15.9 16.9 11.8 1.4 8.2
Median 13.0 16.6 6.8 1.3 8.0
Maximum 53.5 44.8 62.5 9.1 15.1
Minimum 0.2 1.6 0.7 0.0 3.2
Standard deviation 11.6 11.2 13.0 1.3 3.6

30 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 maintained for 60 days at room temperature (21-24°C), determine whether they met each of the recommended
35°C and 45°C, at 75% humidity. The pLDH concentrations or preferred criteria, assessed in the following categories:
in the samples chosen were above average in order to • labelling of the RDT box (58 criteria assessed);
increase the probability of good RDT baseline reactivity,
thereby allowing an interpretable assessment of stability • labelling of the primary cassette packaging (16 criteria
or degradation. assessed);
• Ease-of-use assessment: After technicians had become • labelling of the cassette (11 criteria assessed);
familiar with the test device, they jointly described its • labelling of the buffer bottle (15 criteria assessed);
blood safety characteristics, the quality of the instructions,
• labelling of the accessories (transfer devices, lancets,
the number of timed steps and the total time to a result,
alcohol swabs and desiccant) (19 criteria assessed);
using a standard reference guide (28).
and
• Assessment of labelling, packaging and instructions for
• content and format of the instructions for use (119
use: Technicians assessed the product components to
criteria assessed). See supplemental files for full details.

Figure 5: Testing procedure and calculation of panel detection score and band intensity for product A against a sample
density of 200 parasites/µL
The first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is

Methods
considered detected only if all first test readings, from both lots, are positive, i.e. readings a, b, c and d must be positive.

Product A

Lot 1 Lot 2

Test 1 Test 2 Test 3 Test 4

a b c d
Detected if
Reading Reading Reading Reading Reading Reading Reading Reading
1 2 1 2 1 2 1 2 4 positive
first readings

Based on the positive results of first test reading (2 tests per lot), the mean band intensity score =a+b+c+d/4
(excluding negative results).
a Second reading results are for internal use only

Figure 6: Testing procedure and calculation of panel detection score and band intensity for product A against a sample
density of 2000 parasites/µL
The first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is
considered detected only if all first test readings, from both lots, are positive, i.e. readings a and b must be positive.

Product A

Lot 1 Lot 2

Test 1 Test 2

a b
Detected if
Reading Reading Reading Reading
1 2 1 2 2 positive
first readings

Based on positive results of first test reading (2 tests per lot), in each lot, the mean band intensity score =a+b/2
a Second reading results are for internal use only

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 31
 • RDT anomalies: During testing, technicians regularly used. The result was recorded by a technician at the minimum
reported the RDT anomalies listed below (not all of which specified reading time, and a second technician re-read the
were observed in round 7) and in Fig. AS2.1. When anoma- result within 30 min for internal monitoring and to obtain
lies were noted frequently, a photograph was taken of at information for the manufacturer. Annexes 1 and 2 give a
least one example. descriptive, illustrated summary of the test characteristics
• red background and steps and a guide to interpretation of results.

• red background obscuring test line(s)

• incomplete clearing
5.8. Interpreting the results
• incomplete migration The results of control and test lines were recorded as negative
or positive by each technician. Each test line was read against
• failed migration a standard colour chart and the band intensity graded as 0
• ghost test line(s) (no visible band), 1, 2, 3 or 4 (1 being the weakest colour
intensity and 4 being the strongest). If the control line was
• patchy, broken test line(s)
recorded as “0” (no visible band) by either technician, the
• diffuse test line(s) test was recorded as invalid.
• strip misplaced in cassette (shift)
Figs 5 and 6 illustrate the testing sequence at low and high
• specimen pad not seen in sample window parasite density.
• buffer remains pooled in buffer well
5.9. Recording anomalies
5.7. Performing rapid tests Anomalies are defined as unexpected features that appear
All RDTs were maintained at room temperature (21–24 °C) during performance of an RDT. Anomalies have been observed
until first use. When applicable, the desiccant was inspected since round 1. After the appearance of each, technicians
for colour change, and products were discarded if they agreed on terms with which to identify them. During earlier
were present. Technicians were rotated and blinded to the rounds of testing, their presence was recorded informally
sample type and to each other’s results. RDTs were labelled (and reported to manufacturers), but, since round 6, the
with a sample identification number and the date on which frequency of anomalies has been recorded. Some anomalies
test was performed. The tests were used according to the do not interfere with the interpretation of results, while
manufacturer’s instructions, except that the recommended others may obscure test or control lines and therefore affect
volume of blood was transferred by micropipette from the the interpretation and create confusion. Manufacturers
sample tube; co-packaged blood transfer devices were not are encouraged to reduce or eliminate anomalies and to
acknowledge them in their instructions for use.

6. Data management

Receipt of products was hand-recorded in a RDT register All source documents and electronic records of the study
at the CDC as per standard operating procedures. Data data are maintained in secure storage until the conclusion
associated with specimen collection and characterization of the evaluation, data analysis and publication of the report.
were recorded, first on hard-copy report forms as per the
standard operating procedure at the collection sites (Fig. 2), Individual product testing reports and raw data were sent to
the Hospital of Tropical Diseases (quantitative ELISA results) manufacturers in December 2016 for a 30-day review period
and the CDC (PCR results), then entered directly into Excel, before production of the final report.
followed by importation into a specially developed database.

The results of product panel testing and heat stability testing

conducted at the CDC were recorded on report forms by
each technician individually, as per the standard operating
procedure. The results were entered in duplicate and analysed
for discrepancies.

32 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
7.  Quality assurance

Product testing follows standard operating procedures used for internal monitoring. The summarized results were
developed during previous testing rounds, which are based reviewed in detail, and potential discrepancies were identified
on recommendations by expert consultants, with minor and cross-checked against source laboratory report forms.
modifications by the steering committee before round 7
(28). Overall, the quality of critical steps was controlled as All wild-type parasite samples used in phase 2 were rand-
described below. omized with parasite-negative samples and re-labelled.
Reading of the RDT results by the first and second technician
is blinded.
7.1. Quality of malaria RDTs and
their use 7.3. Quality of WHO specimen bank
All RDTs were stored in a controlled environment at room samples
temperature (21–24 °C). The pouch was opened, and, if
applicable, the desiccant was checked for colour change Standard operating procedures were established for the
immediately before use. The manufacturer’s instructions preparation of all specimen bank samples (26). Culture lines
of parasites and wild-type samples were selected on the

Methods
were followed, except for use of the blood transfer device
provided by the manufacturer: a micropipette was used to basis of previous evidence and data from specific studies. All
ensure the correct blood volume. diluted parasite sample aliquots were stored and transported
at –70°C and were used only once within 8 hours of thawing.
A temperature monitoring device was offered to manufac-
turers to be shipped with the RDTs to the testing site (CDC).
Lots were analysed at temperatures above and below the
7.4. Quality of the product testing
manufacturer’s recommended storage conditions. site
The Division of Parasitic Diseases and Malaria, Center for
7.2. Quality and objectivity of RDT Global Health, CDC, is the main operating component of
readings the Department of Health and Human Services of the USA
for malaria control and prevention. Laboratories within the
The results were read under good lighting, using standard Division are accredited by Clinical Laboratory Improvement
colour charts by trained technicians tested for visual acuity Amendments and are monitored by an internal quality
and were doubly entered into the database. Technicians management system.
were rotated, and the readings of a second technician were

8. Ethical considerations

Each specimen collection site obtained approval from a WHO of blood samples for the purpose of RDT product testing, lot
research ethics review committee and/or a local institutional testing and quality assurance.
review board for specimen collection, transport and archiving

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 33
 9. Data analysis

9.1. Measures of parasite percentage of all tests of a particular product that returned

a positive test result when it should not have been obtained,
detection: panel detection when read at the manufacturer’s recommended minimum
score and positivity rates reading time.

As shown in Fig. 5, a product must return four positive test 9.2.1  Incorrect species identification
results at the manufacturers’ recommended minimum reading
A test is considered to have returned an incorrect species
time (two from lot 1, two from lot 2 at the initial reading time)
result if a positive P. falciparum test line appears when
when tested against a parasite density of 200 parasites/µL to
testing a sample containing non-P. falciparum (P. vivax)
contribute to its PDS. When tested against 2000 parasites/µL
parasites. Fig. 7 illustrates the various possibilities for incor-
(Fig. 6), the product must return two positive tests at the
rect species identification in combination tests. For example,
manufacturers’ recommended minimum reading time (one
if P. falciparum samples result in only a visible pan-specific
from each lot). Thus, the PDS is a measure of inter-test and
(or non-P. falciparum-specific) test line in combination
inter-lot consistency, as well as the ability of the test to
tests, the result is considered to be a false-positive for
detect antigen. The PDS for P. falciparum indicates an RDT
non-P. falciparum parasites.
result that confirms the presence of P. falciparum when tested
against cultured and wild-type P. falciparum samples, while 9.2.2 False-positive results for Plasmodium-
the P. vivax PDS indicates Plasmodium-positive/P. falciparum- negative samples
negative results when tested with wild-type P. vivax samples.
Any positive reading of samples with no Plasmodium parasites
The positivity rate is the percentage of all tests of a particular is considered a false positive. In phase 2, parasite-negative
product that returned a positive result at the manufacturers’ samples are clean negative samples and samples containing
recommended minimum reading time when tested against a other infectious agents (dengue, leishmania, Chagas, schisto-
P. falciparum or P. vivax sample. soma and rapid plasma reagin, which is indicative of syphilis
infection) and immunological factors (rheumatoid factor,
anti-nuclear antibodies, anti-mouse antibodies) (Table 2).
9.2. False-positive results
False-positive results are analysed and reported as two 9.3. Band intensity
groups: those with incorrect species identification and those
that returned a positive result for samples that do not contain All positive test results were recorded with their band inten-
Plasmodium spp. Specifically, the false-positive rate is the sity against a standard reference chart, matched closely to

Figure 7: Classification of incorrect species identification with combination malaria RDTs

Pf/pan combination tests
Panel sample Pf + / Pan - Pf + / Pan + Pf - / Pan + Pf - / Pan -
False-positive
Pf Negative
(non-Pf)
False-positive False-positive
Pv Negative
(Pf) (Pf)

Pf/Pv combination tests

Panel Pf + / Pv - Pf + / Pv + Pf - / Pv + Pf - / Pv -
False-positive False-positive
Pf Negative
(Pv) (non-Pf)
False-positive False-positive
Pv Negative
(Pf) (Pf)

34 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
line colour. On the basis of the results of the first reader, the samples)2 and mean band intensity (for positive tests only
distribution of band intensity results is presented as the mean based on the first reading) after the lots were stored at room
band intensity of positive results. In addition, the intensity temperature (21–25°C) and at 35°C and 45°C for 2 months. At
was expressed for each possible result (0, 1, 2, 3 or 4) as the some point during the 60-day incubation period for the late
percentage recorded at that level1. entry test (CareStart™ Malaria Pf/PAN (pLDH)- RMLM-05071),
the humidity regulator in the 45°C stability chamber was
9.4. Lot agreement compromised leading to water-soaking of all test boxes. The
precise timing of this event and the effect on temperature and
Agreement between test lots is calculated from the number humidity are unknown. Testing was still performed because
of samples that return a positive result on both RDTs tested in all cassette packaging was intact.
that lot against parasite-positive samples at 200 parasites/µL,
and on the single RDT from each lot tested against samples
at 2000 parasites/µL. High inter-lot agreement indicates
9.7. Anomalies
consistency in detecting malaria parasites. When one test is The presence and frequency of commonly observed anoma-
invalid and the other positive, positive agreement is recorded. lies – red background, red background obscuring test line(s),
Fig. 8 shows sample calculations for lot agreement. incomplete clearing, incomplete migration, failed migration,
strip misplaced in cassette (shift), specimen pad not seen in
9.5. Invalid tests the sample window, ghost test line(s), diffuse test line(s),
patchy broken line(s) and buffer remains pooled in buffer
Invalid tests are those deemed invalid during testing of both well – were routinely recorded for all round-7 products.
lots, with samples at 200 parasites/µL and 2000 parasites/µL. Photographs and descriptions are shown in Fig. AS2.1.

9.6. Heat (thermal) stability 9.8. Labelling and instructions

The results of heat stability testing are reported as the for use
number of positive tests against one cultured P. falciparum For each product, technicians recorded whether the product
or one wild-type P. vivax parasite sample at 200 and met each of the recommended criteria. The results were
2000 parasites/µL based on the first reading of two lots at pooled for analysis. The proportions of products that met a
each parasite density (maximum score is 30 (P. falciparum) selection of recommended criteria is presented graphically
or eight (P. vivax) against 200 parasites/µL samples and 10 in Figs 31–38.
(P. falciparum) or four (P. vivax) against 2000 parasites/µL

Results
2 Fifteen tests per lot against 200 parasites/µL samples, five tests
per lot against 2000 parasites/µL for P. falciparum samples, four
1 A standard intensity comparison chart is used, which allows matching tests per lot against 200 parasites/µL samples and two tests per lot
to the closest of four common colour variants of labelled antibodies against 2000 parasites/µL for P. vivax samples. Invalid results were
used in RDTs, each at four levels of intensity. excluded from the analysis.

Figure 8: Explanation of lot agreement calculation

Test results Derived values
(1= positive, 0 = negative) (1= both positive, 0 = both negative)
Lot 1 Lot 2 (a) (b) (d) (f)
Test 1 Test 2 Test 1 Test 2 Lot 1 tests Lot 2 tests Comparison Contribution
reader 1 reader 1 reader 1 reader 1 of lot results to overall
Sample 1 1 1 1 1 1 1 1 1

Sample 2 1 0 0 0 Disagree 0 Can’t 0

compare
Sample 3 0 1 0 1 Disagree Disagree Can’t 0
compare
Sample 4 0 0 0 0 0 0 0 0
Sample 5 1 1 1 1 1 1 1 1
PDS = sum (f) / number of samples = 2/5 = 40
Lot 1 PDS = sum (a) / number of samples = 2 / 5 = 40
Lot 2 PDS = sum (b) / number of samples = 2 / 5 = 40
Positivity = number of positive results / total number of tests = 11 / 20 = 55%
Agreement between tests = (count number of 0 and 1s in (a) and (b)) / (number of samples x 2 lots) = 7 / 10 = 70%
Agreement between lots = (count number of 0 and 1s in (d)) / (number of samples -­‐ number of “can’t compare” in (d)) = 3 /3 = 100%
Note: reader 1 = Technician 1 in raw data files

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 35
 10.  ASSOCIATION BETWEEN PARASITE
DENSITY AND ANTIGEN CONCENTRATION

Malaria RDTs detect parasite-derived antigen. The relation HRP2, pLDH and aldolase. Only samples with antigen values
of the concentration of antigen available from the blood within the 90th percentile for HRP2, pLDH and aldolase
sample (after lysis of red cells and parasites) to the peripheral were selected for the performance panels. Furthermore, the
parasite density varies widely because of a series of host and distribution of antigen levels for HRP2, pLDH and aldolase was
parasite factors (Box 4). compared with that in previous rounds to ensure consistency.
No statistically significant differences in average antigen
In establishing panels for the product testing programme levels between the panels for rounds 1–7 were detected for
that reflect possible variations in antigen concentration for any of the antigens (p > 0.5, Kruskal-Wallis test). Therefore,
parasitaemia of 200 parasites/µL, a large number (> 300) of the panels used for the product testing rounds can be consid-
wild-type parasite samples from clinical cases in different ered comparable (Annex S1).
geographical areas were analysed by quantitative ELISA for

Box 4. Explanations for variable antigen concentrations in samples with the same parasite density
• variation in antigen expression among isolates
• different durations of infections (accumulating antigens)
• different parasite growth stages at the time of collection (expressing different levels of antigens)
• presence of circulating HRP2 from previous cycles of growth
• HRP2 produced by parasites sequestered in the host’s vascular tissues that cannot be accounted for in the estimate of parasite
density on the blood slide (29)

11.  evaluation of malaria rapid

diagnostic tests in the Laboratory
and in the field

Despite the strengths of the product testing programme, the infectious diseases, which can result in false-positive results,
evaluations are not completely analogous to field testing may vary. Therefore, the sensitivity and specificity of an
of malaria RDTs. In order to compose a panel that could be RDT in the field depends on the epidemiological situation.
used to evaluate RDTs reproducibly, blood samples must be The evaluation reported here does not predict sensitivity or
diluted, frozen and stored below −70°C; however, blood that specificity in a given field situation but the rates of detection
has undergone freezing and thawing is lysed and may not of target antigens and false-positive results of RDTs against a
have exactly the same characteristics as fresh blood. Another standardized panel in a controlled, repeatable manner. As the
difference from field evaluation is use of a micro-pipette to panel is meant to be a close approximation to field samples,
place blood in the RDT device rather than the blood transfer the detection rates of different products will be reflected
device provided by the manufacturer. This is necessary because in similar differences in the field. The panel is designed to
blood is collected from a cryo-tube rather than a finger-prick include a large number of samples that are close to the limit
and because the blood transfer devices provided with the of detection of RDTs (200 parasites/µL) and is therefore likely
different products vary (31). This technique also ensures the to discriminate between them more clearly than a field trial.
consistency of testing by reducing the likelihood of operator It follows that, in settings where the parasite density is very
error. As all samples in the panel used for the evaluation are high, no differences in the PDS or positivity rates of tests or
prepared from parasites that express HRP2, the results will much smaller differences will be observed than those reported
not be predictive of field trial results of parasite populations against the WHO evaluation panel. Furthermore, where the
with significant levels of HRP2 deletion (12–13). In addition, parasite density is very low, the detection rates may be lower
the population frequency of blood immunological factors or than those reported here.

36 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Field trials have a place in product selection, particularly parasite densities if significant differences are to be found
in determining which of a short-list of products is most between well-performing products; they must also be closely
appropriate for the technicians and situation of its intended controlled and are therefore expensive. Such trials do not
use in a programme (e.g. ease-of-use characteristics). Such allow comparison of a large number of products. WHO has
trials should have carefully defined objectives and procedures published recommendations for good practice in malaria
designed to achieve them. Trials to determine the probable field trials (32), which should be followed to improve the
field sensitivity and specificity of a product also have a reproducibility and quality of the results.
place but require large samples and populations with low

12. Results

12.1. Summary
Round 7 of WHO malaria RDT product testing provided for the P. falciparum detecting line. The PDS for P. vivax
results for 46 products evaluated against P. falciparum at low densities has improved consistently since round 1
culture samples, and all the products proceeded to evalu- (median, 30%), the results for rounds 2, 3, 4, 5, 6 and 7
ation against wild-type samples collected from parasi- being 75.0%, 51.4%, 61.8%, 65.7%, 82.9% and 90.0%,
taemic patients on three continents and a large panel of respectively. Six products achieved 100% PDS on their
parasite-negative samples. Heat stability was assessed at pan-pLDH and P. vivax pLDH lines when tested against
the temperatures commonly encountered in malaria-endemic P. vivax but had lower scores for their P. falciparum
countries. Thirteen research institutes were engaged in either detecting lines. The median false-positive rate on clean
sample collection or sample characterization to establish negative samples and samples containing other infectious
the evaluation panels. Between February 2016 and August agents was 0%, while samples containing immunological
2016, approximately 65 000 RDTs were tested at the CDC. factors had a median overall false-positive rate of 2.8%.

The main results are presented in Tables 4 and 5, which • A number of RDTs consistently detected malaria at a low
group the RDTs by the species they are designed to detect, parasite density (200 parasites/µL), had low false-positive

Results
i.e. P. falciparum only, P. falciparum and all species or P. falci- rates, were stable at tropical temperatures, are relatively
parum and P. vivax. Note that only tests against P. falciparum easy to use and can detect P. falciparum, P. vivax or both.
and P. vivax were evaluated, and the evaluation therefore This increases the number of well-performing tests from
does not indicate whether a product intended to detect other that in rounds 1–6.
species, i.e. P. malariae, P. ovale, could do so. • The one P. falciparum-only test detecting pf-pLDH did
not meet procurement criteria; however, one combination
PDS values at both high and low parasite concentrations are non-HRP2 detecting RDT met criteria for P. falciparum and
presented, as are false-positive rates and the percentages P. vivax targeting pf-pLDH and pan-pLDH, respectively.
of invalid test results. Tests in each category are listed
alphabetically, but the results are colour-coded according • The performance of products varied at low parasite density
to WHO-recommended RDT procurement selection criteria (200 parasites/µL), but most showed high detection rates
(Box 3); WHO prequalification status is also indicated. When for P. falciparum and P. vivax at 2000 parasites/µL.
choosing an appropriate product, it is important also to • All, except two, round-7 products had an HRP2 detecting
review its thermal stability (Tables 6a and 6b) according to line, and most of these products achieved a high PDS for
the expected conditions of transport and storage in the field. P. falciparum detection at low parasite density.

The results of the evaluation are listed below. • Several combination tests achieved PDS at the upper end
of the range for both P. falciparum and P. vivax. (Fig. S3).
• The overall range of results against wild-type P. falciparum
and negative samples, including P. falciparum PDS, P. falci- • There was minimal lot-to-lot variation in the test perfor-
parum positivity rate and heat stability, were similar to mance of round-7 products.
those in rounds 1–6 (3–8), the false-positivity rates and • Overall, approximately half of the combination tests with
P. vivax PDS and P. vivax positivity rates were similar to Pf and Pan lines in which HRP2 was used for detection of
those in round 6, and better than in previous rounds. P. falciparum, returned positive results only on the HRP2
The median PDS for P. falciparum at low parasite densities band at lower densities of P. falciparum. Results were
in round 7 (89.5%) was slightly higher than in rounds 5 product-specific, with values ranging from 5% to 89%.
and 6 (both 86%) and similar to that seen in round 4 Manufacturers’ instructions should therefore classify
(89.3%). No products in round 7 scored a PDS of 100% P. falciparum infections as positive in either the HRP2
test line alone or in combination with the pan-pLDH line.

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 37
 38
Table 4: Summary of phase 1 performance of 45 malaria RDTsa against 20 cultured P. falciparum lines at low (200) and high (2000) parasite density (parasites/µl)
Panel detection scoreb (n=20) False-positive non-Pf infectionc (%)
Product Product code Manufacturer Invalid rate (%)
200 2000 200 parasites/µl 2000 parasites/µl (n=120)
parasites/µl parasites/µl (n=80) (n=40)
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 100.0 100.0 NA NA 0.0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 100.0 100.0 NA NA 0.0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc.e 100.0 100.0 NA NA 0.0
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 100.0 100.0 NA NA 0.0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 100.0 100.0 NA NA 0.0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 100.0 100.0 NA NA 0.0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line RMSM-05071 Access Bio, Inc. 100.0 (100/35)d 100.0 (100/95)d NA NA 0.0
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 100.0 100.0 NA NA 0.0
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 100.0 100.0 NA NA 0.0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 100.0 100.0 NA NA 0.0
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 100.0 100.0 NA NA 0.0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 100.0 100.0 NA NA 0.0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 100.0 100.0 NA NA 0.5
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 100.0 100.0 NA NA 0.0
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 95.0 100.0 NA NA 0.0
Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 100.0 100.0 NA NA 0.0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 80.0 100.0 NA NA 0.0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 100.0 100.0 NA NA 0.0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc.e 90.0 100.0 NA NA 0.0
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 75.0 100.0 0.0 0.0 (39) 0.5
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 100.0 100.0 0.0 0.0 0.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 80.0 100.0 0.0 0.0 0.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 100.0 100.0 0.0 0.0 0.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 80.0 100.0 0.0 0.0 0.0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 100.0 100.0 0.0 0.0 0.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 100.0 100.0 0.0 0.0 0.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 100.0 100.0 0.0 0.0 0.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 100.0 100.0 0.0 0.0 0.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 100.0 100.0 0.0 0.0 0.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 100.0 100.0 0.0 0.0 0.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 100.0 95.0 0.0 2.5 0.0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 100.0 100.0 0.0 0.0 0.0
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 100.0 100.0 0.0 0.0 0.0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 80.0 100.0 0.0 (78) 0.0 1.5
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 100.0 100.0 0.0 0.0 0.5
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 100.0 100.0 0.0 0.0 0.0
 Table 4: Summary phase-1 performance of 41 malaria RDTs against 20 cultured P. falciparum lines at low (200) and high (2000) parasite density (parasites/µL) (continued)
Panel detection scoreb (n=20) False-positive non-Pf infectionc (%)
Product Product code Manufacturer Invalid rate (%)
200 2000 200 parasites/µl 2000 parasites/µl (n=120)
parasites/µl parasites/µl (n=80) (n=40)
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 100.0 100.0 0.0 0.0 0.0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 100.0 100.0 0.0 0.0 0.0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 100.0 100.0 0.0 0.0 0.0
Malaria Pf/PAN Test PROPMALPFPV001 Real World Diagnostics 100.0 100.0 25.0 97.5 0.0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 100.0 100.0 0.0 0.0 0.0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 90.0 100.0 0.0 (79) 0.0 0.5
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 100.0 100.0 12.5 15.0 0.0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 100.0 100.0 0.0 0.0 0.0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 100.0 100.0 1.3 0.0 0.0
NA, not applicable
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species
a Phase-1 performance tests for CareStart Pf/PAN (pLDH) Ag RDT (RMLM-05071) not conducted
b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive
c Pan or Pv line only positive indicates a false positive non P. falciparum infection
d Product PDS shown along with PDS for HRP2 band and Pf-pLDH band, respectively
e An Alere company

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Results

39
 40
Table 5: Summary of phase 2 performance of 46 malaria RDTs against wild-type (clinical) P. falciparum and P. vivax samples at low (200) and high (2000a) parasite density (parasites/µl)
and Plasmodium spp. negative samples
Total false
Panel detection scoreb False positive rates (%) positive
ratese (%)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl Clean
negative Invalid
Product Product code Manufacturer Pf samples Pv samples Pf samples Pv samples samples rate (%)
False False (n=1210)
Pf samples Pv samples Pf samples Pv samples positive False positive False False positive
(n=100) (n=35) (n=100)a (n=35) non Pf positive Pf non-Pf positive-Pf Plasmodium
infectiond d
infection spp. infection
infectionc (n=140) infectionc (n=70) (n=232)
(n=400) (n=200)
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 80.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 0.0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 93.0 NA 99.0 NA NA 0.0 NA 0.0 0.4 0.0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 98.0 NA 100.0 NA NA 0.0 NA 0.0 0.9 (231) 0.1
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 93.0 NA 100.0 NA NA 0.7 NA 0.0 1.3 0.0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 97.0 NA 99.0 NA NA 0.0 NA 0.0 0.0 0.0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 96.0 NA 100.0 NA NA 0.0 NA 0.0 0.4 0.0
94.0 99.0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line RMSM-05071 Access Bio, Inc. NA NA NA 2.1 NA 1.4 0.4 0.0
(94/38)f (99/92)f
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 94.0 NA 100.0 NA NA 0.0 NA 0.0 0.9 0.0
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 86.0 NA 99.0 NA NA 0.0 NA 0.0 0.0 0.0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 94.0 NA 100.0 NA NA 5.0 NA 1.4 1.7 0.0
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 85.0 NA 99.0 NA NA 0.0 NA 0.0 0.0 0.0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 89.0 NA 100.0 NA NA 0.0 (139) NA 0.0 0.0 0.1
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 86.0 NA 99.0 NA NA 2.9 NA 1.4 0.4 (231) 0.1
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 93.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 0.0
One Step Test for Malaria Pf HRP-II Ag MERISCREEN
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 73.0 NA 99.0 NA NA 0.7 NA 0.0 0.0 0.0
Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 92.0 NA 99.0 NA NA 0.0 NA 0.0 0.0 0.0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 74.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 0.0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 77.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 0.0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 90.0 NA 100.0 NA NA 0.0 NA 0.0 0.0 (231) 0.1
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 67.0 45.7 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 85.0 91.4 98.0 100.0 1.3 0.0 1.0 0.0 0.0 0.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 69.0 71.4 96.0 100.0 1.3 0.0 2.0 0.0 0.9 0.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 88.0 100.0 98.0 100.0 0.5 (399) 0.0 1.0 0.0 1.3 0.1
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 93.0 91.4 98.0 100.0 0.3 (399) 1.4 (138) 1.0 0.0 1.3 (231) 0.3
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 91.0 100.0 99.0 100.0 0.0 0.0 0.5 0.0 3.9 0.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 85.0 85.7 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 96.0 97.1 99.0 94.3 0.8 0.7 0.5 2.9 0.9 0.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 73.0 0.0 100.0 71.4 0.0 0.7 0.0 0.0 1.7 0.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 93.0 94.3 99.0 97.1 1.3 0.0 0.5 0.0 0.0 (231) 0.1
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 85.0 31.4 98.0 100.0 0.3 0.0 1.0 0.0 1.3 0.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 93.0 100.0 99.0 100.0 2.0 0.0 0.5 0.0 3.9 0.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 92.0 25.7 98.0 91.4 0.8 (399) 3.6 (139) 1.0 4.3 33.2 0.2
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 92.0 100.0 100.0 100.0 0.0 0.0 0.0 0.0 0.4 0.0
 Table 5: Summary phase-2 performance of 41 malaria RDTs against wild-type (clinical) P. falciparum and P. vivax samples at low (200) and high (2000a) parasite density (parasites/µL)
and Plasmodium spp. negative samples (continued)
Total false
Panel detection scoreb False positive rates (%) positive
ratese (%)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl Clean
negative Invalid
Product Product code Manufacturer Pf samples Pv samples Pf samples Pv samples samples rate (%)
False False (n=1210)
Pf samples Pv samples Pf samples Pv samples positive False positive False False positive
(n=100) (n=35) (n=100)a (n=35) non Pf positive Pf non-Pf positive-Pf Plasmodium
infectionc infectiond infectionc infectiond spp. infection
(n=400) (n=140) (n=200) (n=70) (n=232)
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 92.0 97.1 98.0 100.0 1.0 0.0 1.0 1.4 (69) 0.4 0.1
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 75.0 100.0 98.0 100.0 1.0 (399) 0.0 (139) 1.0 (199) 1.5 (68) 0.0 (230) 0.6
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 85.0 91.4 99.0 100.0 0.0 0.0 0.0 0.0 (69) 0.0 (229) 0.3
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 91.0 97.1 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 89.0 100.0 99.0 100.0 1.8 0.0 2.0 0.0 0.0 (231) 0.1
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 93.0 88.6 100.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 89.0 57.1 99.0 100.0 0.0 0.0 0.5 (199) 0.0 0.0 (231) 0.3
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 86.0 2.9 99.0 8.6 22.3 4.3 92.5 7.1 24.6 0.0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 92.0 65.7 100.0 100.0 0.3 0.0 1.0 0.0 1.3 0.0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 78.0 85.7 100.0 100.0 0.5 0.7 0.0 1.4 0.0 0.0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 79.0 88.6 99.0 100.0 39.8 0.0 27.5 0.0 22.9 (231) 0.1
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 85.0 88.6 98.0 100.0 0.0 0.0 0.0 0.0 0.0 0.0
Pf, Pv and Pan
82.9 100.0
PALUTOP +4 optima® 5499 ALLDIAG SA 91.0 99.0 1.3 0.7 0.5 0.0 0.0 0.0
(82.9/100)g (100/100)g

NA, not applicable

Recommended WHO
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species Performance measure
procurement criteria
a 3 (3%) of the 100 P. falciparum high parasite density dilution samples were at 5000 parasites/µl rather than 2000
Panel detection score for Pf and Pv 200/µl samples ≥ 75%
b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive
c For combination tests, pan or Pv line, only, positive indicates a false positive non P. falciparum infection
False positive rates against clean negatives < 10%
d Positive Pf line indicates a false positive P. falciparum infection Invalid rate < 5% of tests conducted
e The total number of times a positive result for malaria was generated when it should not have been
f Product PDS shown along with PDS for HRP2 band and Pf-pLDH band, respectively
g Product PDS shown along with PDS for Pv-pLDH band and Pan-pLDH band, respectively

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Results

41
 42
a All
Panel detection scoreb

0
25
50
75
100
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test- RKMAL017
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test- ITP11002-TC25
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test- ITP11003-TC25
Alere Trueline™ - Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40
Alere™ Malaria Ag P.f - 05FK140-40-0

density (parasites/μL)
Asan Easy Test® Malaria Pf/Pan Ag- AM4650-K
Aspen® Malaria Ag Pf - AS0015
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH)- C32RHA25
Biosynex® Malaria Pf/Pan- 0584_K25
Biosynex® Malaria Pf/Pv- 0581_K25
BioTracer™ Malaria P.f Rapid Card- 17912
BioTracer™ Malaria P.f/PAN Rapid Card- 17012
CareStart™ Malaria Pf (HRP2)- RMOM-03091
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT- RMVM-03091
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line- RMSM-05071
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT- RMVM-05072
CareStart™ Malaria Screen RDT- RMAM-05071
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082
careUS™ Malaria Pf (HRP2) Ag - RMO-M05082
DIAQUICK Malaria P.f. Cassette - W06200
ICT MALARIA DUAL TEST - ML03
an invalid rate of 0.6%. However, the test had diminished

90% to 94%, however it cannot be distinguished if this

sites are a high priority in malaria-endemic countries

23). The PDS in other Pf-pLDH tests in which HRP2 was

performance results from detection of HRP2, Pf-pLDH

with a high prevalence of such parasites (12, 13, 33, 34).

for detection of P. falciparum with Pf-pLDH alone. This

or both. Tests that can detect pfhrp2-deleted para-

used to detect Pf on the same test line, ranged from
performance after incubation at 35°C and 45°C (Figs. 22,
test had a PDS of 75%, a false-positive rate of 0% and
• Only one of two tests met the WHO procurement criterion

ICT MALARIA P.F. CASSETTE TEST- ML01

for this product HRP2 and pf-pLDH based results are presented separately in table 4.
Is It... Malaria Pf PAN - MPFPAN050
KHB® Malaria Ag (HRP2) Pf Rapid Test - R-409-50-C
Malaria Pf Rapid Test- GCMAL(pf)-402a
Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a
GMD Malaria Pf test- GMDMALPF001
Malaria Pf/PAN Test - PROMALPFV001
One Step Malaria HRP2/pLDH (P.f/P.v) Test- W056-C
One Step MalariaHRP2 (P.f) Test- W37-C
PALUTOP + pf® - 5531
PALUTOP +4 optima® - 5499
Parahit® f Ver 1.0 - Device - 55IC104-50
QuickProfile™ Malaria Pf/Pv Antigen Test- 71050
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN- MAL-PF/Pan-CAS/25

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv- 11108191040
NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag - MPHRPD-01
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines - 05FK130-40-0

b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
AllTest™ Malaria P.f./Pan Rapid Test Cassette- IMPN-402
200 (pLDH)
200 (HRP2)

2000 (pLDH)
2000 (HRP2)

Aspen® Malaria Ag Pf/Pv - AS0060

The data are shown graphically in Figs. 9–19.

BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH)- C60RHA25

Figure 9: Phase-1 P. falciparum panel detection score of malaria RDTsa at low (200) and high (2000) parasite

200 (Dual antigen)

Parahit f® Ver 1.0 - Dipstick - 55IC103-50

2000 (Dual antigen)

Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit- RKMAL016

but 2 RDTs target HRP2 for falciparum detection. Two products target only pf-pLDH for falciparum detection (RMLM-05071 and C60RHA25). Two products
(RMAM-05071 and 05FK130-40-0) target both HRP2 and pf-pLDH on the same line. One product (RMSM-05071) targets both HRP2 and pf-pLDH on separate lines;
over their results in round 3, while that of others decreased.

spp.-negative samples. Detailed phase-1 and phase-2 results

wild-type P. falciparum and P. vivax parasites and Plasmodium
against cultured P. falciparum parasites, blood containing

of product testing are given in Annexes 3 and 4, respectively.

Tables 4 and 5 summarize the performance of malaria RDTs
PDS of some of the P. falciparum and P. vivax tests improved
mance of the five compulsorily resubmitted products. The
• No consistent pattern was seen in the changing perfor-
 a 3
Panel detection scored

b Phase
0
25
50
75
100
Alere™ Malaria Ag P.f - 05FK140-40-0

at 2000 p/μL;
BioTracer™ Malaria P.f Rapid Card - 17912
BioTracer™ Malaria P.f/PAN Rapid Card - 17012

(parasites/μL)b,c
CareStart™ Malaria Pf (HRP2) Ag RDT - RMOM-03091
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - RMSM-05071
careUS™ Malaria Pf (HRP2) Ag - RMO-M05082
ICT MALARIA P.F. CASSETTE TEST - ML01

(200 parasites/µL) (Fig. 9).
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test - ITP11002-TC25
Aspen® Malaria Ag Pf - AS0015
culture panel

Aspen® Malaria Ag Pf/Pv - AS0060

CareStart™ Malaria Screen RDT - RMAM-05071
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082
Is It... Malaria Pf PAN - MPFPAN050
One Step MalariaHRP2 (P.f) Test - W37-C
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test - ITP11003-TC25
12.2. Phase 1: P. falciparum

NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005

One Step Malaria HRP2/pLDH (P.f/P.v) Test - W056-C
PALUTOP + pf® - 5531
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-03091
The PDS was more variable (75–100%) at low parasite density
(2000 parasites/µL); the PDS of the exception was 95%.
cultured P. falciparum parasites at high parasite density
All but one of the products consistently detected 100% of

PALUTOP +4 optima® - 5499

for this product HRP2 and pf-pLDH based results are presented separately in table 5.
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines - 05FK130-40-0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-05072
Malaria Pf Rapid Test - GCMAL(pf)-402a
Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a
Asan Easy Test® Malaria Pf/Pan Ag - AM4650-K
DIAQUICK Malaria P.f. Cassette - W06200
GMD Malaria Pf test - GMDMALPF001
Malaria Pf/PAN Test - PROMALPFV001
(Table 5, Fig. 10).

Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40

(3%) of the 100 P. falciparum high parasite density dilution samples were at 5000 parasites/μL rather than 2000
Biosynex® Malaria Pf/Pan - 0584_K25
Biosynex® Malaria Pf/Pv - 0581_K25
ICT MALARIA DUAL TEST - ML03
KHB® Malaria Ag (HRP2) Pf Rapid Test - R-409-50-C
negative samples.

Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv- 11108191040
200 (pLDH)
200 (HRP2)

Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test - RKMAL017

2000 (pLDH)
2000 (HRP2)

QuickProfile™ Malaria Pf/Pv Antigen Test - 71050

One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02
200 (Dual antigen)
12.3.1  P. falciparum detection

2000 (Dual antigen)

Parahit® f Ver 1.0 - Device - 55IC104-50

d A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) - C60RHA25
Parahit f® Ver 1.0 - Dipstick - 55IC103-50
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT - RMLM-05071
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag - MPHRPD-01

c All but 2 RDTs target HRP2 for falciparum detection. Two products target only pf-pLDH for falciparum detection (RMLM-05071 and C60RHA25). Two products
AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016

(RMAM-05071 and 05FK130-40-0) target both HRP2 and pf-pLDH on the same line. One product (RMSM-05071) targets both HRP2 and pf-pLDH on separate lines;
2 evaluation panel consisted of 100 clinical blood samples containing wild type P. falciparum. RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots
Figure 10: Phase-2 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000a) parasite density
the high parasite density, with a PDS ≥ 96%. Seventeen of
parum. As in phase 1, all the tests had very high scores at
12.3. Phase 2: wild -type P. falciparum

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
and P. vivax- and Plasmodium spp.-

the 19 products specific for P. falciparum alone achieved

All 46 products in round 7 were designed to detect P. falci-

a PDS ≥ 75% against samples with low parasite density

Results

43
 Only one of two tests met WHO procurement criteria based 12.3.2  P. vivax detection
on detection of P. falciparum with Pf-pLDH alone. This test
achieved a PDS of 75%, a false-positive rate of 0% and an Fig. 11 shows that 25 of 27 (93%) products designed to
invalid rate of 0.6%. The PDS in other Pf-pLDH tests in which detect P. vivax consistently detected ≥ 75% at high parasite
HRP2 was used to detect Pf on the same test line, ranged density (2000 parasites/µL), and 19 (70%) achieved the same
from 90% to 94%, however it cannot be distinguished if threshold of PDS against samples with 200 parasites/µL.
this performance results from detection of HRP2, Pf-pLDH The overall detection rate in low-parasite density wild-type
or both. Tests that can detect pfhrp2 gene-deleted parasites P. vivax samples was lower than that for P. falciparum. At a
are a high priority in malaria-endemic countries with a high low parasite density (200 parasites/µL), 13 products had
prevalence of such parasites (12, 13, 33, 34). a PDS ≥ 90%, and 18 had a PDS < 75% (Table 5, Fig. 11),
which is an improvement on round-5 results, in which only
eight products had a PDS ≥ 90%, and 19 had a PDS < 75%.

Figure 11: Phase-2 P. vivax panel detection score of malaria RDTs at low (200) and high (2000) parasite density
(parasites/μL)a,b
100

75
Panel detection scorec

50

200 (pLDH)
200 (Aldolase)
25
2000 (pLDH)
2000 (Aldolase)

0
Biosynex® Malaria Pf/Pan - 0584_K25

AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402

Aspen® Malaria Ag Pf/Pv - AS0060
CareStart™ Malaria HRP2/pLDH (Pf/Pv) Combo - RMVM-03091
Asan Easy Test® Malaria Pf/Pan Ag - AM4650-K

CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo - RMVM-05072

Biosynex® Malaria Pf/Pv - 0581_K25

Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv- 11108191040
QuickProfile™ Malaria Pf/Pv Antigen Test - 71050
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082

NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005

BioTracer™ Malaria P.f/PAN Rapid Card - 17012

Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016

One Step Malaria HRP2/pLDH (P.f/P.v) Test - W056-C
PALUTOP +4 optima® - 5499
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25

BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) - C60RHA25

Is It... Malaria Pf PAN - MPFPAN050

CareStart™ Pf/PAN (pLDH) Ag RDT - RMLM-05071

CareStart™ Malaria Screen RDT - RMAM-05071

Malaria Pf/PAN Test - PROMALPFV001

Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test - ITP11003-TC25

ICT MALARIA DUAL TEST - ML03

Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25

Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40

a Phase-2 evaluation panel consisted of 35 clinical blood samples containing wild type P. vivax; RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots at 2000
p/μL;
b All RDTs target pan-pLDH or pv-pLDH
c A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.

44 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 Panel detection scoreb/Positivity ratec (%)

0
25
50
75
100

a Phase-2
Alere™ Malaria Ag P.f - 05FK140-40-0

at 2000 p/μL;
BioTracer™ Malaria P.f Rapid Card - 17912 and P. vivax
CareStart™ Malaria Pf (HRP2) - RMOM-03091

positivity rate
BioTracer™ Malaria P.f/PAN Rapid Card - 17012
careUS™ Malaria Pf (HRP2) Ag - RMO-M05082
ICT MALARIA P.F. CASSETTE TEST- ML01
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - RMSM-05071
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test - ITP11002-TC25
Aspen® Malaria Ag Pf/Pv - AS0060

P. vivax samples (Figs 12 and 13).

Aspen® Malaria Ag Pf - AS0015
CareStart™ Malaria Screen RDT - RMAM-05071
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082
One Step MalariaHRP2 (P.f) Test - W37-C
performed well at a high parasite density.

12.3.4  P. falciparum and P. vivax

Is It... Malaria Pf PAN - MPFPAN050

PALUTOP + pf® - 5531
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test - ITP11003-TC25
NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25
One Step Malaria HRP2/pLDH (P.f/P.v) Test - W056-C
12.3.3 Combined detection of P. falciparum

CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-03091

The positivity rate was calculated in addition to the PDS.
As expected, the positivity rates were higher than the PDS
parasite density (200 parasites/µL) (Table 5). Most products

but mirrored the PDS against wild-type P. falciparum and

a PDS ≥ 75% for both P. falciparum and P. vivax at a low
Of the 27 pan-specific and combination tests, 19 (70%) had

PALUTOP +4 optima® - 5499

BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines - 05FK130-40-0
Malaria Pf Rapid Test - GCMAL(pf)-402a
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-05072
Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a
Asan Easy Test® Malaria Pf/Pan Ag - AM4650-K
DIAQUICK Malaria P.f. Cassette - W06200
GMD Malaria Pf test - GMDMALPF001
Malaria Pf/PAN Test - PROMALPFV001
ICT MALARIA DUAL TEST - ML03

c The total number of times a test returned a positive result divided by the total number of times it should have (x100).
KHB® Malaria Ag (HRP2) Pf Rapid Test - R-409-50-C
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv- 11108191040
Alere Trueline™ - Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40
12.3.5 Band intensity

Biosynex® Malaria Pf/Pv - 0581_K25

p < 0.001 for the P. vivax panel).

Biosynex® Malaria Pf/Pan - 0584_K25

Figure 12: Phase-2 P. falciparum panel detection score and positivity rate at 200 parasites/μL a

Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test - RKMAL017

QuickProfile™ Malaria Pf/Pv Antigen Test - 71050

b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive;
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02
Parahit® f Ver 1.0 - Device - 55IC104-50
Parahit f® Ver 1.0 - Dipstick - 55IC103-50
Positivity rate (HRP2)
Positivity rate (pLDH)

BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) - C60RHA25

One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag - MPHRPD-01
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT - RMLM-05071
Panel detection score (HRP2)
Panel detection score (pLDH)

AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402

evaluation panel consisted of 100 clinical blood samples containing wild-type P. falciparum. RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016
(for phase 2)). A positive correlation was found between the

Of the combination RDT products containing a pan test band

chart and calculated the mean band intensity for positive
cians graded positive results according to a standard colour

results (Annex 4, Tables A3.2 (for phase 1), A4.2 and A4.3

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
positive results on both the P. falciparum and pan test
low-density P. falciparum samples, 51.6% (2473/4796) gave
that gave a positive indication for P. falciparum against
p < 0.001 for the P. falciparum phase-2 panel and r = 0.82,
PDS and band intensity (Spearman rank correlation, r = 0.75,
Although RDTs do not provide quantitative results, the techni-

Results

45
 bands, and 47.8% (2292/4796) were positive only on the intensities lower than the corresponding P. falciparum test
P. falciparum test band. A small proportion (0.6%, 31/4796) bands, respectively. Only 0.1% of tests had a pan band inten-
were positive only on the pan test band. sity larger than the corresponding P. falciparum test band.

When the pan test band in the combination products was When tested at low parasite density, none of the tests
positive, the intensity of the band was the same as the achieved 75% with a band intensity > 2 for P. falciparum
P. falciparum test band in 11.2% of tests, while 33.0%, 39.1% or P. vivax, although 12 achieved at least 50% with this
and 16.7% of the pan tests bands were one, two and three intensity for P. falciparum and 1 for P. vivax.

Figure 13: Phase-2 P. vivax panel detection score and positivity rate at 200 parasites/μL a
100
Panel detection scoreb/Positivity ratec (%)

75

50

Positivity rate (pLDH)

25 Positivity rate (Aldolase)
Panel detection score (pLDH)
Panel detection score (Aldolase)
0
Biosynex® Malaria Pf/Pan - 0584_K25

AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402

Aspen® Malaria Ag Pf/Pv - AS0060
Asan Easy Test® Malaria Pf/Pan Ag - AM4650-K

Biosynex® Malaria Pf/Pv - 0581_K25

QuickProfile™ Malaria Pf/Pv Antigen Test - 71050

Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv- 11108191040
BioTracer™ Malaria P.f/PAN Rapid Card - 17012

careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082

NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005

Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016
Is It... Malaria Pf PAN - MPFPAN050

PALUTOP +4 optima® - 5499

BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25

BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) - C60RHA25

One Step Malaria HRP2/pLDH (P.f/P.v) Test - W056-C

CareStart™ Malaria Screen RDT - RMAM-05071

One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02

Malaria Pf/PAN Test - PROMALPFV001

CareStart™ Malaria Pf/PAN (pLDH) Ag RDT - RMLM-05071
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25

CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-05072

ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test - ITP11003-TC25

CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-03091

Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a

ICT MALARIA DUAL TEST - ML03

Alere Trueline™ - Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40

a Phase-2 evaluation panel consisted of 35 clinical blood samples containing wild type P. vivax; . RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots at
2000 p/μL;
b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive;
c The total number of times a test returned a positive result divided by the total number of times it should have (x100).

46 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 False-positive rate (%)

a Phase-2
0
2
4
6
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit- RKMAL016
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test- RKMAL017
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test- ITP11002-TC25
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test- ITP11003-TC25
Alere Trueline™ - Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40
Alere™ Malaria Ag P.f - 05FK140-40-0
AllTest™ Malaria P.f./Pan Rapid Test Cassette- IMPN-402
Asan Easy Test© Malaria Pf/Pan Ag- AM4650-K

current illness or blood abnormality.

Aspen© Malaria Ag Pf/Pv - AS0060
Aspen© Malaria Ag Pf - AS0015
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH)- C32RHA25
12.3.6 False-positive rates

BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH)- C60RHA25

Biosynex© Malaria Pf/Pan- 0584_K25
Biosynex© Malaria Pf/Pv- 0581_K25
BioTracer™ Malaria P.f Rapid Card- 17912
BioTracer™ Malaria P.f/PAN Rapid Card- 17012
CareStart™ Pf/PAN (pLDH) Ag RDT - RMLM-05071
CareStart™ Malaria Pf (HRP2) Ag RDT - RMOM-03091
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-03091
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - RMSM-05071
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-05072
CareStart™ Malaria Screen RDT - RMAM-05071
P. vivax test lines (Fig. 15). Fifteen products had false-positive
None of the products had a false-positive rate > 10% with 52

rates > 5.6% (for one or both lots), against samples containing
three products had false-positive rates > 10% with pan or
clean-negative samples of the P. falciparum test line (Fig. 14);

careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082

careUS™ Malaria Pf (HRP2) Ag - RMO-M05082
DIAQUICK Malaria P.f. Cassette - W06200
ICT MALARIA DUAL TEST - ML03
ICT MALARIA P.F. CASSETTE TEST- ML01
Is It... Malaria Pf PAN - MPFPAN050
KHB© Malaria Ag (HRP2) Pf Rapid Test - R-409-50-C
Malaria Pf Rapid Test- GCMAL(pf)-402a
Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a
GMD Malaria Pf test - GMDMALPF001
Malaria Pf/PAN Test - PROMALPFV001
NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005
One Step MalariaHRP2 (P.f) Test- W37-C
One Step Malaria HRP2/pLDH (P.f/P.v) Test- W056-C
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag - MPHRPD-01
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02
PALUTOP + pf© - 5531
PALUTOP +4 optima© - 5499
Parahit f© Ver 1.0 - Dipstick - 55IC103-50
Parahit© f Ver 1.0 - Device - 55IC104-50
QuickProfile™ Malaria Pf/Pv Antigen Test- 71050
Rapid 1-2-3 HEMA© CASSETTE MALARIA PF/PAN- MAL-PF/Pan-CAS/25
eight instances of false positivity > 10%).

SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines - 05FK130-40-0

Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv- 11108191040

evaluation panel included 100 Plasmodium spp.-negative samples, of which 52 were clean negatives from healthy volunteers with no known
Figure 14: Phase-2 P. falciparum (P. falciparum test line) false-positive rate against clean-negative samplesa
and those of a further six were 11.1–24.1% in both lots. These

for samples containing immunological factors (seven of the

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
in previous rounds. False positivity was seen predominantly
rates are worse than those in round 6 but similar to those
immunological factors. The rates of 9 of these were 5.6–7.4%,

Results

47
 48
False-positive rate (%)

a Phase-2
0
10
20
30
40
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test - ITP11003-TC25
Alere Trueline™ - Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40
AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402
Asan Easy Test© Malaria Pf/Pan Ag - AM4650-K
Aspen©Malaria Ag Pf/Pv - AS0060
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) - C60RHA25
Biosynex© Malaria Pf/Pan - 0584_K25

with no known current illness or blood abnormality.

Biosynex© Malaria Pf/Pv - 0581_K25
BioTracer™ Malaria P.f/PAN Rapid Card - 17012
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT - RMLM-05071
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-03091
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-05072
CareStart™ Malaria Screen RDT - RMAM-05071
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082
only four products was the false-positivity rate > 3.3%, and
The false-positivity rates for samples containing non-
Plasmodium spp. agents were similar to those in round 6. In

only one had a false positivity rate > 10% (10% and 13%

ICT MALARIA DUAL TEST - ML03

Is It... Malaria Pf PAN - MPFPAN050
Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a
Malaria Pf/PAN Test - PROMALPFV001
NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005
One Step Malaria HRP2/pLDH (P.f/P.v) Test - W056-C
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02
PALUTOP +4 optima© - 5499
QuickProfile™ Malaria Pf/Pv Antigen Test - 71050
Rapid 1-2-3 HEMA© CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv- 11108191040

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
evaluation panel included 100 Plasmodium spp.-negative samples of which 52 were clean negatives, from healthy volunteers
Figure 15: Phase-2 Plasmodium spp. (pan or P. vivax test line) false-positive rate against clean-negative samplesa
schistosoma, leishmaniasis, Chagas disease and dengue.
in each of the two lots); three products had false-positivity

against all four of the samples of infections pathogens used:

rates of 6.7% for one or both lots. False positivity was seen
Only 21 samples contained non-Plasmodium infectious showed > 10% false positivity for a non-P. falciparum
agents and 27 samples contained immunological factors. infection when tested against samples of P. falciparum at
For detailed information on the blood abnormalities and 200 or 2000 parasites/µL.
pathogens that generated false-positive results in specific
products, see Annex 4 (Tables A4.6–A4.9). There was no clear trend of higher false-positive rates in tests
with higher PDS, indicating no clear association between
Products were assessed for false-positivity rates for species the sensitivity and specificity of the tests at these detection
that they were not designed to detect (Tables A4.4 and A4.5). thresholds (Figs 16 and 17).
Overall, the rates were low; only two combination products

Figure 16: Phase-2 P. falciparum false-positive ratea versus P. falciparum panel detection scoreb
at low parasite density (200 parasites/μL)
6
False-positive rate (%)

0
0 25 50 75 100
P. falciparum PDS at 200 parasites/μL
a False-positiverate is for clean-negatives, only;
b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.

Results
Figure 17: Phase-2 P. vivax false-positive ratea versus P. vivax panel detection scoreb
at low parasite density (200 parasites/μL)
40
False-positive rate (%)

30

20

10

0
0 25 50 75 100
P. vivax PDS at 200 parasites/μL
a False-positive rate is for clean negatives only.
b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 49
 12.4. Performance of resubmitted products
Of the 46 products in round 7, 15 (33%) had been evaluated resubmissions): two had improved performance against
previously. For six of the resubmissions, this was the second P. falciparum (increases of 6 and 7 percentage points), and
testing, and nine had been tested more than twice. Figs 18 three showed worse performance (decreases of 7, 8 and 11
and 19 show the performance in the current and previous percentage points). The changes in the two pan-detecting
testing of products against wild-type P. falciparum and products in their ability to detect P. vivax differed from
P. vivax at 200 parasites/µL and clean-negative samples that those in round 3: the PDS of one increased by 5 percentage
had been resubmitted compulsorily and voluntarily. points, while that of the other dropped from 91% in round
3 to 0 in round 7.
The change in PDS between the two rounds varied for the five
products that had not been tested since round 3 (compulsory

Figure 18: Phase-2 P. falciparum panel detection scorea at low parasite density (200 parasites/μL) during initial and
subsequent testing of compulsorily and voluntarily resubmitted malaria RDTs

False-positive Plasmodium spp. rate

on clean-negative samplesb (%)
Panel detection scorea

Compulsory
retest Voluntary retest

Panel detection score (prior submission)

Panel detection score (Rd 7)
False-positive (prior submission)
False-positive (Rd 7)
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
b Clean-negative blood samples from healthy volunteers with no known current illness or blood abnormality.

50 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
For the 10 products that were voluntarily resubmitted for consecutive submissions against P. vivax at lower parasite
testing, no significant correlation was found between the density (Spearman rank correlation, r = 0.503, P = 0.20).
PDS for P. falciparum at lower parasite density in consecu-
tive submissions (Spearman rank correlation, r = – 0.30, P On re-testing, approximately half of the resubmitted products
= 0.405). The median change in detection of P. falciparum was (7/15) showed no change or an improvement in their false-
+7.5% (range, –8.0 to 40.0%), which was almost significantly positivity rate against clean negative samples; the median
different from zero (Wilcoxon signed rank test, P = 0.052). change in false-positivity rate was +0.4%. Most of the
Most of the products (8/10) detected P. vivax, and detection of changes on re-testing were small (< 2.5%), except for two
this parasite improved overall (median change, 28.6%; range, products, in which the false-positivity rate decreased by
–8.6 to 65.7%), which was almost statistically significant 7.3% for one product and increased by 22.9% for another.
(Wilcoxon signed rank test, P = 0.058). No statistically Both of these products were voluntarily resubmitted for
significant correlation was found between the PDS of testing in Round 7.

Figure 19: Phase-2 P. vivax panel detection scorea at low parasite density (200 parasites/μL) during initial and subsequent
testing of compulsorily and voluntarily resubmitted malaria RDTs

100 100

False-positive Plasmodium spp. rate

on clean-negative samplesb (%)
90
80 80
Panel detection scorea

70
60 60
50
40 40
30
20 20
10
0 0

Results

Compulsory
retest Voluntary retest

Panel detection score (prior submission)

Panel detection score (Rd 7)
False-positive (prior submission)
False-positive (Rd 7)
a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.
b Clean-negative blood samples from healthy volunteers with no known current illness or blood abnormality.

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 51
 13.  Heat stability

13.1. Summary Many combination test products had pan lines that poorly
detected low-density P. falciparum samples at baseline.
A single P. falciparum culture sample and single wild-type Furthermore, tests with a baseline positivity < 100% showed
P. vivax sample were used as the reference samples to test unpredictable variation in positivity rates on subsequent
heat stability. Continuous in vitro culture of a wild-type testing, indicating that they were on the borderline of
P. vivax sample is difficult, largely because of selective visibility. Two of the three combination tests with good (i.e.
invasion of reticulocytes by the parasite. Round 7 was scoring at least 28/30) baseline pan line reactivity to the
the second in which the stability of test lines to detect low-density sample showed good detection throughout,
non-P. falciparum parasites was tested. Because of the while one showed a marked reduction in performance after
large number of aliquots used to assess heat stability, fewer 2 months at 45 °C. The stability of pan-pLDH-detecting test
replicate RDTs were tested against P. vivax, with four assessed lines was much poorer than that of HRP2-detecting test
against the 200 parasites/µL sample and two against the lines (Figs 20–25).
2000 parasites/µL sample, for each of the two lots. The results
of heat stability testing are summarized in Tables 6a and 6b,
and detailed results are presented in Annex 4 (Tables A4.10–
13.3. 
Plasmodium vivax
A4.18) and in Figs. 20–29, which show the results for the two Testing of the heat stability of P. vivax-detecting lines using
lots combined. The maximum obtainable scores were 30 (15 a P. vivax clinical sample was introduced in round 6. Many
tests per lot) against P. falciparum for 200 parasites/µL and 10 (11/14) of the combination RDTs with a pan-LDH test line
for 2000 parasites/µL (five tests per lot). The maximum score were heat stable after 2 months’ storage at 45 °C when
obtainable against P. vivax was 8 for 200 parasites/µL (four tested against a wild-type P. vivax sample. Two of the 11,
tests per lot) and 4 for 2000 parasites/µL (two tests per lot). however, showed some variation in performance under other
conditions: one had slightly poorer performance at baseline
Confirmatory data on the stability of recent production and after storage at room temperature, and the other had
lots of all tests can be obtained from the manufacturers very poor performance after storage at 35 °C. Of the three
and through the WHO–FIND lot-testing programme during tests that did not detect 100% of samples after storage at
product selection for procurement of RDTs. 45 °C, two showed 100% detection at baseline but some
decrease after storage at 35 °C and 45 °C (one with only
13.2.  P
 lasmodium falciparum a slight decrease and the other with a more significant
decrease). The third of the three tests performed very poorly
All of the 19 P. falciparum-only RDTs with an HRP2 test line at baseline (only 2 of 8 samples detected) and did not detect
were heat stable. Thus, they detected a cultured P. falciparum any samples after storage at any temperature.
sample the same number of times when stored at room
temperature (< 25°C) or at 35°C or 45°C (with 75% humidity) The P. vivax pLDH line appeared to be more stable, 11 of 13
for 2 months (Fig. 20) as at baseline. One P. falciparum-only being heat stable under all testing conditions and a further
detecting product had a line that detected P. falciparum pLDH one showing only a slight decrease in detection at 35 °C and
(in addition to an HRP2 line). Both lines were heat stable. 100% detection at 45 °C. The exception was a product in
which the P. vivax pLDH line did not detect any of the P. vivax
Of the 27 combination tests, 25 had an HRP2-detecting samples at baseline or after storage at room temperature and
line. Of these, 24 tests were heat stable against a cultured only slightly better performance after incubation with one of
P. falciparum sample. The 25th showed slight deterioration eight samples detected after storage at 35 °C and three of
after 2 months’ storage at 45 °C. One of the 24 heat-stable eight samples detected after storage at 45 °C (Figs 26–29).
products showed a slight loss in detection when stored at
35 °C but not at 45 °C. The two combination tests with only Overall, both P. falciparum and P. vivax detecting prod-
pLDH-detecting lines for P. falciparum both showed some ucts appeared more stable against samples with high
heat instability: one with a slight decline in performance at (2000 parasites/µL) rather than low (200 parasites/µL)
35 °C and then again at 45 °C, and the second with a major parasite density, as minor deterioration is not apparent at
decrease in performance at 35 °C and then again at 45 °C. high parasite density.

52 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 Table 6a: Heat stability testing results for 46 malaria RDTs on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µL).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°Ca
Positive test results for Positive test results for Positive test results for Positive test results for
P. falciparum (Pf line) P. falciparum (pan line) P. falciparum (Pf line) P. falciparum (pan line)
200 parasites/µL 200 parasites/µL 2000 parasites/µL 2000 parasites/µL
Product Product Manufacturer
code Room Room Room Room
Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C
temp temp temp temp
Number of tests positive (max. 30) Number of tests positive (max. 30) Number of tests positive (max. 10) Number of tests positive (max. 10)
Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
30 30 30 30 10 10 10 10
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line RMSM-05071 Access Bio, Inc. NA NA NA NA NA NA NA NA
(30/30)b (30/30)b (30/30)b (30/30)b (10/10)b (10/10)b (10/10)b (10/10)b
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
GCMAL(pf)-
Malaria Pf Rapid Test Zhejiang Orient Gene Biotech Co., Ltd. 30 30 30 29 (29) NA NA NA NA 10 10 10 10 NA NA NA NA
402a
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
One Step Test for Malaria Pf HRP-II Ag MERISCREEN
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 30 30 30 29 (29) NA NA NA NA 10 10 10 10 NA NA NA NA
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 30 29 30 30 0 0 0 0 10 10 10 10 10 10 10 10
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan
05FK60AI-40 Alere Medical Private Limited 30 30 30 30 14 11 21 10 10 10 10 10 10 10 10 10
(HRP-II/pLDH)
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 30 30 30 30 0 3 0 5 10 10 10 10 9 10 10 10
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 30 30 30 30 23 26 15 3 10 10 10 10 10 10 10 10
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 30 30 30 30 15 25 27 30 10 10 10 10 10 10 10 10
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 30 30 30 30 24 18 8 2 10 10 10 10 10 10 10 10
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 30 30 30 29 0 0 0 0 10 10 10 10 10 10 10 10
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 30 30 30 30 30 29 30 21 10 10 10 10 10 10 10 10
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 30 30 29 28 0 0 2 0 10 10 10 10 10 9 10 10
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 30 30 30 30 30 28 30 30 10 10 10 10 10 10 10 10
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 30 30 30 30 1 0 1 4 10 10 10 10 9 10 10 10

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
(continued)

Results

53
 54
Table 6a: Heat stability testing results for 46 malaria RDTs on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µL).
Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35°C and 45°Ca (continued)
Positive test results for Positive test results for Positive test results for Positive test results for
P. falciparum (Pf line) P. falciparum (pan line) P. falciparum (Pf line) P. falciparum (pan line)
200 parasites/µL 200 parasites/µL 2000 parasites/µL 2000 parasites/µL
Product Product Manufacturer
code Room Room Room Room
Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C
temp temp temp temp
Number of tests positive (max. 30) Number of tests positive (max. 30) Number of tests positive (max. 10) Number of tests positive (max. 10)
Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 30 30 28 30 28 29 28 28 10 10 10 10 10 10 10 10
NGB-
NG-Test MALARIA Pf/Pan (pLDH) NG Biotech 30 30 30 30 16 15 26 20 10 10 10 10 10 10 10 10
MAL-W23-005
MAL-PF/Pan-
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN Hema Diagnostic Systems 30 30 30 30 0 5 0 10 10 10 10 10 10 10 10 10
CAS/25
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 28 30 26 17 (29) NA NA NA NA 10 10 10 10 NA NA NA NA
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
GCMAL(pf/
Malaria Pf/Pv Rapid Test Zhejiang Orient Gene Biotech Co., Ltd. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
pv)-402a
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
One Step Test for Malaria Pf/Pv Ag MERISCREEN
MFLRPD-02 Meril Diagnostics Pvt. Ltd. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
Malaria Pf/Pv Ag
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 30 30 30 30 NA NA NA NA 10 10 10 10 NA NA NA NA
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline
11108191040 Alere Medical Private Limited 30 30 30 30 NA NA NA NA 10 10 10 9 (9) NA NA NA NA
Malaria Ag Pf/Pv
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 30 30 30 30 30 30 30 30 10 10 10 10 10 10 10 10
NA, not applicable

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species
a Positive results presented in the table are based on stability of a positive reader 1 result
b Product result shown along with results for HRP2 band and Pf-pLDH band, respectively
 Table 6b: Heat stability testing results for 27 combination malaria RDTs on a wild-type P. vivax sample at low (200) and high (2000) parasite density (parasites/µL).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°Ca
Positive test results for Positive test results for Positive test results for Positive test results for
P. vivax (Pv line) Plasmodium (pan line) P. vivax (Pv line) Plasmodium (pan line)
200 parasites/µL 200 parasites/µL 2000 parasites/µL 2000 parasites/µL
Product Product Manufacturer
code Room Room Room Room
Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C Baseline 35°C 45°C
temp temp temp temp
Number of tests positive (max. 8) Number of tests positive (max. 8) Number of tests positive (max. 4) Number of tests positive (max. 4)
Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined Lots 1 and 2 combined
Pf and pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited NA NA NA NA 8 7 4 8 NA NA NA NA 4 4 4 4
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan
05FK60AI-40 Alere Medical Private Limited NA NA NA NA 8 8 8 8 NA NA NA NA 4 4 4 4
(HRP-II/pLDH)
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. NA NA NA NA 7 7 8 8 NA NA NA NA 4 4 4 4
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd NA NA NA NA 8 8 8 8 NA NA NA NA 4 4 4 4
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. NA NA NA NA 8 8 7 7 NA NA NA NA 4 4 4 4
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. NA NA NA NA 8 8 8 8 NA NA NA NA 4 3 4 4
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex NA NA NA NA 8 8 8 8 NA NA NA NA 4 4 4 4
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. NA NA NA NA 8 8 8 8 NA NA NA NA 4 4 4 4
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. NA NA NA NA 2 0 0 0 NA NA NA NA 3 1 4 2
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. NA NA NA NA 8 8 8 8 NA NA NA NA 4 4 4 4
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL NA NA NA NA 8 7 8 8 NA NA NA NA 4 4 4 4
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. NA NA NA NA 8 8 8 8 NA NA NA NA 4 4 4 4
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech NA NA NA NA 8 8 7 5 NA NA NA NA 4 4 4 4
MAL-PF/Pan-
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN Hema Diagnostic Systems NA NA NA NA 8 8 8 8 NA NA NA NA 4 4 4 4
CAS/25
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 8 8 8 8 NA NA NA NA 4 4 4 4 NA NA NA NA
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 8 8 8 8 NA NA NA NA 4 4 4 3 (3) NA NA NA NA
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 8 8 8 8 NA NA NA NA 4 4 4 4 NA NA NA NA
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 8 8 8 8 NA NA NA NA 4 4 4 4 NA NA NA NA
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 8 8 8 8 NA NA NA NA 4 4 4 4 NA NA NA NA
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 8 8 8 8 NA NA NA NA 4 4 4 4 NA NA NA NA
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 8 8 8 8 NA NA NA NA 4 4 4 3 (3) NA NA NA NA
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 0 0 1 3 NA NA NA NA 0 0 1 0 NA NA NA NA
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 8 8 8 8 NA NA NA NA 4 4 4 4 NA NA NA NA
One Step Test for Malaria Pf/Pv Ag MERISCREEN
MFLRPD-02 Meril Diagnostics Pvt. Ltd. 8 8 8 8 NA NA NA NA 4 4 4 4 NA NA NA NA
Malaria Pf/Pv Ag
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 8 8 8 8 NA NA NA NA 4 4 4 4 NA NA NA NA
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline
11108191040 Alere Medical Private Limited 8 8 7 8 NA NA NA NA 4 4 4 4 NA NA NA NA
Malaria Ag Pf/Pv
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 8 8 8 8 8 8 8 8 4 4 4 4 4 4 4 4
NA, not applicable
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species  Pvom, Plasmodium vivax, ovale and malariae

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
a Positive results presented in the table are based on stability of a positive reader 1 result

Results

55
 Figure 20: Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a low-density
P. falciparum sample (200 parasites/μL). Positivity rate at baseline and after 60 days’ incubation
30 Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test - RKMAL017
No. of positive results from two lotsa

ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test - ITP11002-TC25

Alere™ Malaria Ag P.f - 05FK140-40-0
Aspen© Malaria Ag Pf - AS0015
BioTracer™ Malaria P.f Rapid Card - 17912
20
CareStart ™ Malaria Pf (HRP2) Ag RDT - RMOM-03091
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - RMSM-05071
careUS™ Malaria Pf (HRP2) Ag - RMO-M05082

10 DIAQUICK Malaria P.f. Cassette - W06200

ICT MALARIA P.F. CASSETTE TEST - ML01
KHB © Malaria Ag (HRP2) Pf Rapid Test - R-409-50-C
GMD Malaria Pf test - GMDMALPF001
0 One Step MalariaHRP2 (P.f) Test - W37-C
Baseline RT 35 °C 45 °C One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag - MPHRPD-01
PALUTOP + pf© - 5531
Parahit© f Ver 1.0 - Device - 55IC104-50
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines - 05FK130-40-0

Malaria Pf Rapid Test - GCMAL(pf)-402a

Parahit f© Ver 1.0 - Dipstick - 55IC103-50
a Maximum score is 30 (15 tests x 2 lots)

Figure 21: Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a high-density
P. falciparum sample (2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.

10 Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test - RKMAL017

No. of positive results from two lotsa

ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test - ITP11002-TC25

Alere™ Malaria Ag P.f - 05FK140-40-0
8 Aspen© Malaria Ag Pf - AS0015
BioTracer™ Malaria P.f Rapid Card - 17912
6 CareStart ™ Malaria Pf (HRP2) - RMOM-03091
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - RMSM-05071
careUS™ Malaria Pf (HRP2) Ag - RMO-M05082
4
DIAQUICK Malaria P.f. Cassette - W06200
ICT MALARIA P.F. CASSETTE TEST - ML01
2 KHB © Malaria Ag (HRP2) Pf Rapid Test - R-409-50-C
Malaria Pf Rapid Test - GCMAL(pf)-402a

0 GMD Malaria Pf test - MDMALPF001

Baseline RT 35 °C 45 °C One Step MalariaHRP2 (P.f) Test - W37-C
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag - MPHRPD-01
PALUTOP + pf© - 5531
Parahit f© Ver 1.0 - Dipstick - 55IC103-50
Parahit© f Ver 1.0 - Device - 55IC104-50
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines - 05FK130-40-0
a Maximum score is 10 (5 tests x 2 lots);

56 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Figure 22: Heat stability of P. falciparum-specific test line in combination tests against a low-density
P. falciparum sample (200 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test - ITP11003-TC25
Alere Trueline™ - Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40
AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402
Asan Easy Test® Malaria Pf/Pan Ag - AM4650-K

Aspen® Malaria Ag Pf/Pv - AS0060

BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25
Biosynex® Malaria Pf/Pv - 0581_K25
30
No. of positive results from two lotsa

BioTracer™ Malaria P.f/PAN Rapid Card - 17012

CareStart ™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-03091
CareStart ™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-05072
CareStart ™ Malaria Screen RDT - RMAM-05071
20
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082
ICT MALARIA DUAL TEST - ML03
Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a
Malaria Pf/PAN Test - PROMALPFV001
10
NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005
One Step Malaria HRP2/pLDH (P.f/P.v) Test - W056-C
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02

0 PALUTOP +4 optima® - 5499

Baseline RT 35 °C 45 °C QuickProfile™ Malaria Pf/Pv Antigen Test - 71050
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv - 11108191040

Biosynex® Malaria Pf/Pan - 0584_K25

CareStart ™ Malaria Pf/PAN (pLDH) Ag RDT - RMLM-05071
Is It... Malaria Pf PAN - MPFPAN050
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) - C60RHA25
a Maximum score is 30 (15 tests x 2 lots)

Figure 23: Heat stability of P. falciparum-specific test line in combination tests against a high-density

Results
P. falciparum sample (2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test - ITP11003-TC25
Alere Trueline™ - Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40
AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402
Asan Easy Test® Malaria Pf/Pan Ag - AM4650-K
Aspen® Malaria Ag Pf/Pv - AS0060
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) - C60RHA25
10
No. of positive results from two lotsa

Biosynex® Malaria Pf/Pan - 0584_K25

Biosynex® Malaria Pf/Pv - 0581_K25
8 BioTracer™ Malaria P.f/PAN Rapid Card - 17012
CareStart ™ Malaria Pf/PAN (pLDH) Ag RDT - RMLM-05071
6 CareStart ™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-03091
CareStart ™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-05072

4 CareStart ™ Malaria Screen RDT - RMAM-05071

careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082
ICT MALARIA DUAL TEST - ML03
2
Is It... Malaria Pf PAN - MPFPAN050
Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a
0 Malaria Pf/PAN Test - PROMALPFV001
Baseline RT 35 °C 45 °C
NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005
One Step Malaria HRP2/pLDH (P.f/P.v) Test - W056-C
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02
PALUTOP +4 optima® - 5499
QuickProfile™ Malaria Pf/Pv Antigen Test - 71050
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25

Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv - 11108191040
a Maximum score is 10 (5 tests x 2 lots)

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 57
 Figure 24: Heat stability of pan line of combination tests against a low-density P. falciparum sample (200 parasites/μL).
Positivity rate at baseline and after 60 days’ incubation.
QuickProfile TM Malaria Pf/Pan Test - 71063
30 Parascreen® - Rapid Test for Malaria Pan/Pf - 503030025
No. of positive results from two lotsa

BioTracerTM Malaria Pf/PAN Rapid Card - 17012

First Response ® Malaria Ag. pLDH/HRP2 Combo Card - PI16FRC
Is It… Malaria Pf/Pv Device - AL030
20 Meriscreen Malaria Pf/Pan Ag - MHLRPD-01
EzDxTM Malaria Pan/Pf Rapid Test Detection kit - RK MAL 001
RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C30RHA25
ATOMORAPIDTM Malaria (PF/PAN) - MMAL01
10 OnSite Malaria Pf/Pan Ag Rapid Test - R0113C
BIONOTE MALARIA P.f.& Pan Ag Rapid Test Kit - RG19-08
Humasis Malaria P.f/Pan Antigen Test - ANMAL-7025
One Step Malaria P.f/Pan Whole Blood Test - W62-C
0
Baseline RT 35 °C 45 °C
a Maximum score is 30 (15 tests x 2 lots)

Figure 25: Heat stability of pan line of combination tests against a high-density P. falciparum sample (2000 parasites/μL).
Positivity rate at baseline and after 60 days’ incubation.
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016
Alere Trueline™ - Rapid test kit for Mala ria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40
10
No. of positive results from two lotsa

Asan Easy Test® Malaria Pf/Pan Ag - AM4650-K

Aspen® Malaria Ag Pf/Pv - AS0060
8
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25
Biosynex® Malaria Pf/Pan - 0584_K25
6
BioTracer™ Malaria P.f/PAN Rapid Card - 17012

CareStart ™ Malaria Screen RDT - RMAM-05071

4 Is It... Malaria Pf PAN - MPFPAN050
NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005
2 PALUTOP +4 optima® - 5499
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25

0 CareStart ™ Malaria Pf/PAN (pLDH) Ag RDT - RMLM-05071

Baseline RT 35 °C 45 °C AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402
ICT MALARIA DUAL TEST - ML03
a Maximum score is 10 (5 tests x 2 lots)

Figure 26: Heat stability of pan line of combination tests against a low-density P. vivax sample (200 parasites/μL).
Positivity rate at baseline and after 60 days’ incubation.
Alere Trueline™ - Rapid test kit for Mala ria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40
8 Asan Easy Test® Malaria Pf/Pan Ag - AM4650-K
No. of positive results from two lotsa

Aspen® Malaria Ag Pf/Pv - AS0060

BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25
6 Biosynex® Malaria Pf/Pan - 0584_K25
BioTracer™ Malaria P.f/PAN Rapid Card - 17012
CareStart ™ Malaria Screen RDT - RMAM-05071
4
Is It... Malaria Pf PAN - MPFPAN050
PALUTOP +4 optima® - 5499
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25
2
CareStart ™ Malaria Pf/PAN (pLDH) Ag RDT - RMLM-05071
NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005
0 ICT MALARIA DUAL TEST - ML03
Baseline RT 35 °C 45 °C
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016
AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402
a Maximum score is 8 (4 tests x 2 lots)

58 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Figure 27: Heat stability of pan line of combination tests against a high-density P. vivax sample (2000 parasites/μL).
Positivity rate at baseline and after 60 days’ incubation
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit - RKMAL016

4 Alere Trueline™ - Rapid test kit for Mala ria Ag Pf/Pan (HRP-II/pLDH) - 05FK60AI-40
No. of positive results from two lotsa

AllTest™ Malaria P.f./Pan Rapid Test Cassette - IMPN-402

Asan Easy Test® Malaria Pf/Pan Ag - AM4650-K
3 Aspen® Malaria Ag Pf/Pv - AS0060
Biosynex® Malaria Pf/Pan - 0584_K25
BioTracer™ Malaria P.f/PAN Rapid Card - 17012
2 CareStart ™ Malaria Pf/PAN (pLDH) Ag RDT - RMLM-05071
CareStart ™ Malaria Screen RDT - RMAM-05071
ICT MALARIA DUAL TEST - ML03
1
Is It... Malaria Pf PAN - MPFPAN050
NG-Test MALARIA Pf/Pan (pLDH) - NGB-MAL-W23-005
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN - MAL-PF/Pan-CAS/25
0
Baseline RT 35 °C 45 °C PALUTOP +4 optima® - 5499

BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C32RHA25

a Maximum score is 4 (2 tests x 2 lots)

Figure 28: Heat stability of P. vivax-specific test line in combination tests against a low-density P. vivax sample
(200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation.
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test - ITP11003-TC25
8 BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) - C60RHA25
No. of positive results from two lotsa

Biosynex® Malaria Pf/Pv - 0581_K25

CareStart ™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-03091
6 careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082
Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a
One Step Malaria HRP2/pLDH (P.f/P.v) Test - W056-C
4
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02

Results
PALUTOP +4 optima® - 5499
QuickProfile™ Malaria Pf/Pv Antigen Test - 71050
2
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv - 11108191040
CareStart ™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-05072
Malaria Pf/PAN Test - PROMALPFV001
Baseline RT 35 °C 45 °C
a Maximum score is 8 (4 tests x 2 lots)

Figure 29: Heat stability of P. vivax-specific test line in combination tests against a high-density P. vivax sample
(2000 parasites/μL). Positivity rate at baseline and after 60 days’ incubation.
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test - ITP11003-TC25
4 Biosynex© Malaria Pf/Pv - 0581_K25
No. of positive results from two lotsa

CareStart ™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-03091

careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag - RMV-M05082
3 One Step Malaria HRP2/pLDH (P.f/P.v) Test - W056-C
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag - MFLRPD-02

PALUTOP +4 optima© - 5499

2
QuickProfile™ Malaria Pf/Pv Antigen Test - 71050
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv - 11108191040

1 BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) - C60RHA25

Malaria Pf/Pv Rapid Test - GCMAL(pf/pv)-402a
CareStart ™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT - RMVM-05072
0
Baseline RT 35 °C 45 °C Malaria Pf/PAN Test - PROMALPFV001

a Maximum score is 4 (2 tests x 2 lots)

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 59
 14.  description of Ease of
use, anomalies, Labelling and
instructions for use

14.1. Ease of use 14.3. Labelling and instructions

After becoming proficient in using a product, two technicians for use
submitted a joint agreed assessment of its usability. The Adherence to a list of recommendations for instructions for
results, which are a description of the product with emphasis use and product labelling were assessed for the first time
on aspects considered important for ease of use in the field, in Round 7. Figs 31–38 show the percentages of products
are presented in Table 7. The assessment did not include a that adhered to the recommendations, grouped by theme.
comparison of blood transfer devices, which are critical to
both the safety and the accuracy of the testing procedure Generally good adherence was found to the recommenda-
and pose a significant challenge to many users. These may tions for labelling of the main package (Fig. 31) and the
vary by manufacturer in many products. Procurement deci- device (Fig. 32), with exceptions in the guidance on storage
sions should be based on which transfer devices are best conditions and the inclusion of appropriate warning labels.
suited for the intended users, which should be discussed Labelling of the buffer bottle (Fig. 33) and accessories (Figs
with the manufacturer before procurement. It is strongly 34–36) met only a few recommendations (see below). The
recommended that RDT packaging, contents, safety and ease instructions for use were highly variable, and many recom-
of use be assessed in the field as part of product selection mendations, including critical ones, were not met.
(Annex S2, Table AS2.1).
An important area of divergence from the recommendations
was for laboratory safety. For example, none of the blood
14.2. Anomalies transfer devices carried labels indicating that they were for
In round 7, technicians regularly recorded anomalies from single use only, and 59% of lancet packages had no indication
a list of problems encountered with some production lots that those with damaged packaging should not be used (Fig.
evaluated in past rounds of testing and at WHO–FIND lot- 35). The instructions for use of less than 10% of products
testing laboratories. Since March 2012, these observations advised disposal of tests in biohazard waste containers, and
have been included in all WHO–FIND lot testing reports those of less than 20% advised disposal of lancets in sharps
and were recorded as part of product testing for the first containers (Fig. 38). Only 26% of the instructions advised that
time in round 5. Table 8 shows the percentage of tests per a new pair of gloves should be used at each step (Fig. 38).
product in which specific anomalies were observed and
Important omissions were also found in basic product
the frequency of tests with an anomaly in each product.
information: 28% of instructions for use did not mention
Generally, users should be aware of major anomalies that
that some necessary materials were not included in the kit
may be encountered in production lots (Fig. AS2.1), as they
(Fig. 37), and 33% did not list limitations of product. In terms
can affect interpretation of RDT results. In round 7, 33
of product specifications, nearly all the instructions listed
of the 46 products had between one and five different
the diagnostic sensitivity and specificity of the product, but
types of anomaly; in 13 products, no anomaly was seen
few mentioned analytical sensitivity or specificity or gave
(Table 8, Fig. 30). Incomplete clearing and red background
information on parasite densities and reference methods
(not obscuring test lines) were the most common anomalies,
(Fig. 37). Adherence to recommendations for describing
seen in 48% and 24% of products, respectively. Incomplete
procedures was also variable. While all gave good guidance
migration, failed migration and a red background obscuring
on the interpretation of line combinations for positive results,
the test lines were seen next most often, in 15%, 11% and
fewer than half advised that a faint line should be considered
11% of products, respectively. In most (31) of the 33 products
a positive result (Fig. 38).
with anomalies, they were found in < 1% of the tests; in two
products, anomalies occurred in 1.4% of tests (Table 8). This
rate is much lower than that in round 6, when all products
had between one and six anomalies and approximately half
had a frequency > 2%.

60 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Figure 30: Percentage of RDTs with various anomalies observed in production lots
100

80
Percentage of products

60
1-2% frequency
40 <1% frequency
Not seen
20

0
Any anomaly

Incomplete clearing

Red background

Patchy broken test lines

Failed migration

Red background obsuring test line

Incomplete migration

Strip misplaced in cassette (shift)

Type of anomaly

Results

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 61
 62
Percent
Pr Percent

100

50

0
od Pr U

100
uc

50

0
tc od re ses
uc co in
od gn te
e tn
am iz rn
(a ed at
nd e

100
sy ion
sy m all
m bo y
bo ls
100

In l)

4
85
11
te
nd
In N ed
o. us le C
vi of
tro e gi om

87
13
te bi
lit pli
di st
ag s y es
st
Le no in an wi
ga ki
st t

4
da th

7
ic

89
lm rd
(
100

Le an sy
m
a: Standard of box labelling

ga uf
lm ac bo
t u l)

100
an re
Le uf r's
ga a ct na
lm ur m
an er e

100
's
uf a
Figure 31: Adherence to box labelling recommendations

ac dd
Lo tu re
re ss

4
tn In

96
r's cl
Ex
um C ud
be on es
pi ta
ra r(
an ct co
tio m

76
24
n d m
da sy er Percent
te m ci
100

50

(a bo In al
l) cl

2
nd u na

98
Q M In de m
ua a
sy
m cl s e
te ud "M
2

nt
98

ity ria bo es
l)
2 In al
ls cl ar
of
m p 98 ud an ia
St r ov es tig "
e
9

at
or id In n
91

W ag er cl t ar o
e ia ed ud
ar ls ge rA
22

c p 78 g

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
ni o es te
ro d
c: Completeness of information displayed on the product box

ng nd ta
63

s
37

iti vi rg sp
or on de ec
s d et
ed ie
30

pr
59
11
ec (s a s
(as on box)

U
7

ym
93

au nt
tio bo ni
qu ig
ls en
ns ) e /s

30
70

(s fo
63
37

ym rp

No
ro

Yes
bo
b: Completeness of product name

ls du
)

9
2
ct
89

Partially
15

85
Figure 32: Adherence to cassette labelling recommendations
a: Completeness of information displayed
on the cassette packaging
100 2 2 2
98 30 17 17 41 50 26 91

83 83
70 43
Percent

50 57
48

30

9
0
e
e

l)
o)

)
l)

)
l)
us

ls
am

ls
bo

bo
bo

og

bo

bo
m
ed

m
tn

ym

No
rl

ym

ym
sy

sy
nd

o
uc

(s

(s

(s
d

nd
od

te

Partially
e
c

n
m

ns
i
In

(a
st
Pr

on
r(
na
no

tio

Yes
te

iti
be
r's

au
ag

da

nd
um
re

ec
di

co
n
tu

tn

tio

pr
tro

e
ac

s/
Lo

ra

ag
vi

uf

ng
pi

or
In

an

Ex

ni
St
lm

ar
W
ga
Le

b: Standard of cassette c: Completeness of information

labelling displayed on the cassette
100 100 7
11 11
9
61 11
85
78
Percent

Percent

50 50

26

2
0 0
Labeling legibility
ia e

el n
ev am

r w me
n

ls
tio

No
br t n

ffe ci

Low
bu spe
ab uc

Partially
or rod

an lled

Medium
P

Yes
be
d

High
La

No response

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 63
 Figure 33: Adherence to buffer bottle labelling recommendations
a: Standard of buffer bottle labelling
100
13
26

61
Percent

50

0
Use of internationally recognized symbols

b: Completeness of information displayed

on the buffer bottle
100 9 4
26 70 52 26 35 24 28 100
30
91
4
74 74 72 72
65 65
Percent

50
48

30

0
ck

)
l)
r

)
o)

)
)

l)
l)

ls
ffe

ls
o.
U

bo

bo
bo

pa
og

bo
bo
IF

(n
Bu

m
ym

rl

ym
ym
or

st
ns

sy

sy
(o
s:

te
(s
&/

No
io

(s
(s
nt

nd
e

d
at
ic

an
x
te

ns
m

s
an
bo

(a
st

in

on
on

r(
na

Not applicable
tio
no

am

te

iti
on

be
C

bo

au
r's
ag

nd
da
ex

um

Partially
o

ec
re
di

co
ls

n
le

ha
tu

pr
tn

tio
(a

tro

ib

e
ac

Yes
rt

s/
ag
Lo

ra
ss
de

vi

ng
lie
uf

pi

or
po
In
co

an

ar

ni
Ex

St

ar
te
or
ce

lm

W
no
en

e
ga

um
er

te
Le

ol
ef

da
v
R

s'

n
tio
nt
te

ra
on

pi
Ex
C

Figure 34: Accessory labelling – use of internationally recognized symbols

100
72 9 9 78
4
13
48
39
Percent

50
No
39 Not applicable
39
26 Yes
22 Accessory not included
0 2
Blood transfer Lancet Alcohol swab Dessicant
device

64 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Figure 35: Completeness of information on accessory packaging – blood transfer device and lancet
a: Blood transfer device
100
80 87 85 85 98
Percent

50
No
Not applicable
4 Yes
20
13 15 11
0 2
e

bo e
m d

l)
be
m

ym g
na an

bo
l)
(s ka
e
na

um

ym
by e

n ac
n us
y

tn

(s
tio r p
or

tio d

Lo
ss

e
ca te
ca de

us
ce

di u
ifi n

in O
nt Inte

le
Ac

ng
Si
y
e

tit
id

an
ce

qu
vi
de

b: Lancet
100
30 20 28 28 33 22 59

41 39
30 33 33
28
Percent

50
2 No
39 39 39 39 39 39 39 Yes
Accessory
not included

0
m d

bo e
bo e
te

l)
e

r
na an

be

ym g
ym g

bo
m

da

l)
l)
e

(s cka
(s ka
na

um

m
by e

n ac
n
n us

sy

ed pa
tio
ry

tn

tio r p

(
at ed
so

us ed
Lo

e
ca te
r

us
ic d
es

pi

be ag
di u
tif ten

Ex
io

in O
c

le

to am
Ac

en In

ng

ot D
Si
y
id

tit

-n
an
ce

qu
vi
de

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 65
 Figure 36: Completeness of information on accessory packaging – dessicant and alcohol swab
a: Dessicant
100
22 48 100 37

78

43
Percent

50
52
No
Not applicable
Yes
20

0
m d

n
e

ls
na an

tio
m

bo
na

ta
by e

m
n us

re
y

sy
or

rp
io d
ss

te
or
at e
ic d

in
ce

tif ten

xt

e
(te
Ac

ng
en In

ng

ha
ni

rc
ar
id

ou
W
ce

ol
C
vi
de

b: Alcohol swab
100
61 61 61 22 24 30 17 50

43
39 37
30
Percent

50
11 No
Yes
39 39 39 39 39 39 39 39
Accessory
not included

0
te
e

co am d

bo e
bo e

l)
n

r
be
m

n an

ym ag
ym ag

bo
tio

l)
da

l)
e
na

um

(s ck
tra

(s ck

ym
se

ed pa
a
io
y

en

tn
u

(s
or

tio r p
t
ra
io d
y

nc

Lo

us ed
ss

e
b
at e

ca te
pi

us
n
d
ce

be ag
n

di u
Ex
tif ten

in O

le
Ac

to am
d

ng
en In

an
c

ot D
i

Si
ct
du

y
tit
id

ro

-n
an
ce

,p

qu
vi

tic
de

ep
tis
An

66 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Figure 37: Completeness of information included in the IFU: intended use and precautions and limitations
a: Product information and Intended use b: Precautions and Limitations
100 100
100 13 100 100 100 100 28 9 11 37 7 33
91 89 93
87
72
67
63

Percent
Percent

50 50

No
Yes

0 0

)
e
ed
e

te
)

e
e

ne
le
n

ne

ng
od

nc
am

io

io

da
ire
ip

ag

o
to
ct

at

ra
ta
tc

nc

qu
tn

st
m
n
un

is
as
uc

re
tio
i

ea
da
pr

ss
uc

or
tf

le

tu
r
od

ra

tl
f

la
uc

y
od

pe
in

ra
t
sa

pi

(a
Pr

g
(a

ca
od

pe
Pr

ty
n

ex

ka
As

ns
io

ed

ni
Pr

en

m
ac
ct

tio
ch
id

te
n
im
te

p
yo
ov

ita
te
de

ge
if
ec

be
pr

m
e
r-

ra
Sp
y

us

Li
re
ot
sa

to
us
tn

tu

ts
As

N
ac
bu

Ki
N
uf
d

an
ire

m
qu

of
re

ct
ls

ta
ia

on
er

C
at
M

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 67
 68
R
oo
m
te
m
pe
ra An
Pr C tu al Percent
ep on re Percent yt
a
100

fir

50

0
m be

100

50
re (d ical

0
fin go fore et s
ec en
ge P o u tio sit
ra ut d co se An n ivi

72
28
nd on nd al lim ty

13
87

iti yt it)
us ne o ic
e al

11
89
of w g n sp
U a lc
lo
ve D ec
se oh s ia ifi
gn ci

74
o

26
ol ty
4
D U s os
11
85

fb
is lo s w tic
po Set od e o ab se

4
11
sa

85
co t fl
D li u ra an D ns
is n nt ns ce ia iti
po b do fe t gn vi
ty
w r

11
4

89
sa ios os
n
96

li af de tic
N n e ty r ea v ic
eg bi e sp
at oh sh di Pa ec

100
i a a ng ra ifi
Po ve za rp
s t im re site ci
re r ty
9

si fe d
91

In

50
50
te tive
su d w con e re e
rp lt- as t nc ns
re res
al
ll te aine D e itie
ta ul in co r fo iffe m s

17
83
t t- e nt r 4 re et a
a: Performance Specifications

Al ion a co ai ho nd
9

ll ne Pl nt s ds
91

ll of
in d lin mb r as p

7
93
e e in
b: Test Procedure
at m ec
co iffe co i od ific
m r en m o ns iu at
C F bi bi
4
m io
96
tp na
on ollo nat
io o s t
sp ns
w
11
52
37

si p.
de in ns itiv ions
e
g f
100
rf ac or re
ai
nt tio in s
te n va ults
lid

50
11

fo
39

st ri
lin

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
e nv res
ul
al t
9

as i
91
No

Yes

po d re
si su
tiv lt
4
Partially

e
96

re
su
lt
Not applicable

46
54
Figure 38: Completeness of information included in the IFU – procedure and performance specifications.
 Table 7: Ease-of-use description of 46 malaria RDTs included in round 7
Blood safetya Instruction qualityb Buffer

Product Product Manufacturer Items included in RDT boxc

code

Mixing wells
involved
Retractable
needle
Strip Exposed
Score (max. 3)
Mixing wells
involved
Retractable
needle
Strip Exposed
Score (max. 3)
Combined score
(max. 5)
Number of timed
steps
Total time to
result
Desiccant with colour
indicator (yes/no)
Container does
not puncture
Does not flow
freely
Insufficient
volume
Empty (bottle
or vial)
Discoloured
Blood transfer
device
Format
Language of
instruction
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen
RKMAL017 Advy Chemical Private Limited 1 NA 1 2 2 2 4 1 20 no pipette cassette English
Detection Test
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 1 0 1 2 2 2 4 1 20 no loop cassette English Alcohol Swab / Lancet
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 1 1 1 3 2 2 5 1 20 no loop cassette English Alcohol Swab / Lancet
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 1 0 1 2 2 2 4 1 20 yes loop cassette English Alcohol Swab / Lancet
inverted
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 1 0 1 2 2 2 4 1 20 no cassette English Alcohol Swab / Lancet
cup
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line RMSM-05071 Access Bio, Inc. 1 0 1 2 2 2 4 1 20 no pipette cassette English Alcohol Swab / Lancet
careUS™ Malaria Pf (HRP2) Ag" RMO-M05082 WELLS BIO, INC 1 0 1 2 2 2 4 1 20 no pipette cassette English Alcohol Swab / Lancet
English,
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 1 0 1 2 2 2 4 1 20 no pipette cassette Alcohol Swab / Lancet
German
GMD Malaria Pf test MDMALPFH005 Medical Diagnostech (Pty) Ltd 1 0 1 2 2 2 4 1 30 no pipette cassette English Alcohol Swab / Lancet
inverted
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 1 0 1 2 2 2 4 1 15 yes cassette English Alcohol Swab / Lancet
cup
Shanghai Kehua Bio- inverted
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C 1 1 1 3 2 2 5 1 15 no cassette English Alcohol Swab / Lancet
engineering Co., Ltd. cup
Zhejiang Orient Gene Biotech
Malaria Pf Rapid Test GCMAL(pf)-402a 1 NA 1 2 2 2 4 1 20 no pipette cassette English
Co., Ltd.
Guangzhou Wondfo Biotech
One Step Malaria HRP2 (P.f) Test W37-C 1 0 1 2 2 2 4 1 15 yes pipette cassette English Alcohol Swab / Lancet
Co., Ltd.
One Step Test for Malaria Pf HRP-II Ag
GMDMALPF001 Meril Diagnostics Pvt. Ltd. 1 NA 1 2 1 1 3 1 20 no pipette cassette English
MERISCREEN Malaria Pf HRP-II Ag
English,
PALUTOP + pf® 5531 ALLDIAG SA 1 NA 1 2 2 2 4 1 20 no loop cassette
French
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 1 1 0 2 2 2 4 1 25 no pipette dipstick English Alcohol Swab / Lancet
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 1 1 1 3 2 2 5 1 25 no pipette cassette English Alcohol Swab / Lancet
inverted
Alere™ Malaria Ag P.f. 05FK140-40-0 Standard Diagnostics, Inc. 1 0 1 2 2 2 4 1 20 yes cassette English Alcohol Swab / Lancet
cup
inverted
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 1 0 1 2 2 2 4 1 15 yes cassette English Alcohol Swab / Lancet
cup
Pf and Pan
inverted
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 1 0 1 2 2 2 4 1 20 no cassette English Alcohol Swab / Lancet
cup
inverted
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 1 0 1 2 2 2 4 1 20 no cassette English Alcohol Swab / Lancet
cup
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 1 NA 1 2 2 2 4 1 20 no pipette cassette English
Alere Trueline™ – Rapid test kit for Malaria
05FK60AI-40 Alere Medical Private Limited 1 NA 1 2 2 2 4 1 30 no loop cassette English
Ag Pf/Pan (HRP-II/pLDH)
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 1 NA 1 2 2 2 4 1 30 no loop cassette English
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 1 0 1 2 2 2 4 1 20 yes loop cassette English Alcohol Swab / Lancet
inverted
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 1 NA 1 2 2 2 4 1 15 no cassette English
cup

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Results

69
 70
Table 7: Ease-of-use description of 46 malaria RDTs included in round 7 (continued)
Blood safetya Instruction qualityb Buffer

Product Product Manufacturer Items included in RDT boxc

code

Mixing wells
involved
Retractable
needle
Strip Exposed
Score (max. 3)
Mixing wells
involved
Retractable
needle
Strip Exposed
Score (max. 3)
Combined score
(max. 5)
Number of timed
steps
Total time to
result
Desiccant with colour
indicator (yes/no)
Container does
not puncture
Does not flow
freely
Insufficient
volume
Empty (bottle
or vial)
Discoloured
Blood transfer
device
Format
Language of
instruction

Hangzhou AllTest Biotech

AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 1 NA 1 2 2 2 4 1 10 no pipette cassette English
Co. Ltd.
MAL-PF/Pan-
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN Hema Diagnostic Systems 1 0 1 2 2 2 4 1 20 no pipette cassette English Alcohol Swab / Lancet
CAS/25
inverted
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 1 0 1 2 2 2 4 1 30 no cassette English Alcohol Swab / Lancet
cup
Medsource Ozone Biomedicals
Is It... Malaria Pf PAN MPFPAN050 1 NA 1 2 2 2 4 1 20 yes x loop cassette English
Pvt. Ltd.
NGB-
NG-Test MALARIA Pf/Pan (pLDH) NG Biotech 1 0 1 2 2 2 4 1 30 yes pipette cassette English
MAL-W23-005
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 1 NA 1 2 2 2 4 1 30 no pipette cassette English
Pf and Pv
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag
RMVM-05072 Access Bio, Inc. 1 0 1 2 2 2 4 1 20 no pipette cassette English Alcohol Swab / Lancet
Combo RDT
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag inverted
RMVM-03091 Access Bio Ethiopia 1 0 1 2 2 2 4 1 20 no cassette English Alcohol Swab / Lancet
Combo RDT cup
Rapid Test Kit for Malaria Ag Pf/Pv- Alere Alere Medical Private
11108191040 1 NA 1 2 2 2 4 1 30 no loop cassette English
Trueline Malaria Ag Pf/Pv Limited
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 1 1 1 3 2 2 5 1 20 no loop cassette English Alcohol Swab / Lancet
inverted
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 1 NA 1 2 2 2 4 1 15 no cassette English
cup
Guangzhou Wondfo Biotech
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C 1 0 1 2 2 2 4 1 15 yes pipette cassette English Alcohol Swab / Lancet
Co., Ltd.
ADVANCED QUALITY™ ONE STEP Malaria
ITP11003-TC25 InTec Products, Inc. 1 0 1 2 2 2 4 1 20 no loop cassette English Alcohol Swab / Lancet
(p.f/p.v.) Tri-line Test
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 1 NA 1 2 2 2 4 1 20 no pipette cassette English
Malaria Pf/PAN Test PROMALPFV001 Real World Diagnostics 1 0 1 2 2 2 4 1 30 no pipette cassette English Alcohol Swab / Lancet
One Step Test for Malaria Pf/Pv Ag
MFLRPD-02 Meril Diagnostics Pvt. Ltd. 1 NA 1 2 1 1 3 1 20 no pipette cassette English
MERISCREEN Malaria Pf/Pv Ag
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 1 NA 1 2 2 2 4 1 30 no pipette cassette English

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 1 0 1 2 2 2 4 1 20 no pipette cassette English Alcohol Swab / Lancet
GCMAL(pf/pv)- Zhejiang Orient Gene
Malaria Pf/Pv Rapid Test 1 NA 1 2 2 2 4 1 20 no pipette cassette English
402a Biotech Co., Ltd.
Pf and Pv and Pan
English,
PALUTOP +4 optima® 5499 ALLDIAG SA 1 NA 1 2 2 2 4 1 20 no loop cassette
French
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species 
IFU, instructionsfor use
a Mixing wells involved; Yes=0; No=1; retractable needle: yes=1; no=0; strip exposed, not within card or cassette: exposed =0, covered=1
b No diagrams=0; diagram of results=1; diagram of result and method=2
c Procurers should verify which accessories accompany test kits with the manufacturer and ensure they procure the appropriate products.
 Table 8: Percentage distribution of anomalies observed by product in phase 2
Percentage of tests with specified anomaly
Percentage
of tests with Red Strip
Product Product code Manufacturer Patchy
at least one Red background Incomplete Incomplete Failed misplaced
broken test
anomaly background obsuring test clearing migration migration in cassette
line
line(s) (shift)
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 0.1 0.0 0.0 0.0 0.0 0.0 0.1 0.0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 0.2 0.1 0.0 0.0 0.0 0.0 0.1 0.0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 0.1 0.0 0.0 0.0 0.1 0.0 0.0 0.0
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 0.1 0.1 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 0.1 0.1 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line RMSM-05071 Access Bio, Inc. 0.2 0.1 0.0 0.0 0.0 0.0 0.0 0.1
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 1.4 0.8 0.4 0.2 0.0 0.0 0.0 0.0
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 0.1 0.0 0.0 0.1 0.0 0.0 0.0 0.0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 0.2 0.2 0.0 0.0 0.0 0.0 0.0 0.0
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 0.1 0.1 0.0 0.0 0.0 0.0 0.0 0.0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
One Step Test for Malaria Pf HRP-II Ag
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 0.2 0.0 0.0 0.1 0.0 0.0 0.1 0.0
MERISCREEN Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 0.2 0.1 0.1 0.0 0.0 0.0 0.0 0.0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 0.1 0.0 0.0 0.0 0.0 0.1 0.0 0.0
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 0.2 0.1 0.0 0.1 0.0 0.0 0.0 0.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0.1 0.0 0.0 0.0 0.1 0.0 0.0 0.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 0.6 0.0 0.0 0.4 0.1 0.2 0.0 0.0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 0.2 0.2 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0.5 0.2 0.0 0.3 0.0 0.0 0.0 0.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0.1 0.0 0.0 0.0 0.0 0.1 0.0 0.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 0.5 0.5 0.0 0.1 0.0 0.0 0.0 0.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 0.8 0.2 0.0 0.5 0.0 0.2 0.0 0.0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 0.2 0.2 0.0 0.0 0.0 0.0 0.0 0.0
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0.2 0.2 0.0 0.0 0.0 0.0 0.1 0.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Results

71
 72
Table 8: Percentage distribution of anomalies observed by product in phase 2 (continued)
Percentage of tests with specified anomaly
Percentage
of tests with Red Strip
Product Product code Manufacturer Patchy
at least one Red background Incomplete Incomplete Failed misplaced
broken test
anomaly background obsuring test clearing migration migration in cassette
line
line(s) (shift)
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0.2 0.0 0.0 0.0 0.2 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0.6 0.3 0.1 0.2 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0.2 0.2 0.0 0.0 0.1 0.0 0.0 0.0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0.1 0.1 0.0 0.0 0.0 0.0 0.0 0.0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0.7 0.4 0.1 0.0 0.2 0.1 0.0 0.0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 0.1 0.1 0.0 0.0 0.0 0.0 0.0 0.0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0.3 0.0 0.0 0.3 0.0 0.0 0.0 0.0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 1.4 0.6 0.1 0.5 0.1 0.0 0.0 0.1
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0.1 0.1 0.0 0.0 0.0 0.0 0.0 0.0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.1

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
15. Discussion of key findings

This report describes the performance of many of the therefore a field evaluation of the accuracy of RDTs in a
commercially available malaria antigen-detecting RDTs specific epidemiological context in the hands of the intended
manufactured under the ISO 13485:2003 quality standard. users. The panel is designed to mimic fresh blood samples
For malaria RDTs to improve the management of febrile from actual cases as closely as possible, while allowing direct
illness in malaria-endemic areas, they must have adequate: comparison of a large number of products simultaneously,
• sensitivity, to detect nearly all clinically significant cases with control for confounding factors, and is calibrated to a
of malaria; level likely to discriminate differences in the performance
of various products. The discussion points below should
• specificity, to accurately discriminate non-malarial therefore be taken into account in interpreting the results.
febrile illness from malaria in order to ensure appropriate
management and accurate disease monitoring;
• stability, to maintain accuracy after transport and storage
15.1. Panel detection score and its
in ambient conditions; and relation to sensitivity
• ease-of-use, and adequate labelling and instructions Evaluation of the RDTs against the phase-2 wild-type parasite
for use to ensure safe, correct preparation and accurate panel with a parasite density of 200 parasites/µL (Figs 10 and
interpretation of results. 11) revealed a range of frequency and consistency of antigen
detection between products, recorded as the PDS. As expected,
Malaria RDTs were evaluated in terms of these four require- testing at higher parasite density (2000 parasites/µL) resulted
ments in order to assist national malaria control programmes in smaller differences in performance. As two tests from two
and other procurement agencies in selecting products appro- different lots were tested at 200 parasites/µL and as all four
priate for their needs. The evaluation constitutes the laboratory tests had to be positive in order for a sample to be considered
component of the WHO programme for prequalification of in “detected” by an RDT, a positive result indicates the ability of
vitro diagnostics. The panel used ensured successful discrimi- a product to detect the target antigen in the sample and to do
nation between the RDTs evaluated. A number of products this consistently (both tests from both lots). A parasite density
showed a high rate of antigen detection, a low false-positive of about 200 parasites/µL should be detected to ensure high
rate and good heat stability. These attributes are essential for field sensitivity for clinically significant malaria infection in
tests used as a basis for decisions about malaria treatment in many malaria-endemic populations (11).
the populations of most malaria-endemic countries.
The PDS in the panels used in this evaluation differs from
Overall, the mean PDS against low-density P. falciparum the test sensitivity in clinical settings for five main reasons.
samples in round 7 was 87.2%, slightly higher than in round
6 (83.6%) and continuing the pattern of improvements in (i) The performance of different lots or batches of the
each round.1 For P. vivax tests, the mean PDS of 76.8% is the same product may vary. Variation in lot performance
highest achieved so far.2 The median false-positive rate was is an issue for all diagnostics; therefore, the results
0%, which is lower than in round 6 (0.5%). Overall, a high level found in the evaluation may not predict the results for
of performance has been maintained in P. falciparum-only subsequent RDT lots. It is important to test lots before
tests, and improved performance has been seen in P. vivax- their distribution in the field to ensure that the expected
detecting RDTs. As previously, too few Pf-pLDH-based RDTs performance is maintained (section 16.2). Discussion
were submitted for evaluation: only three were assessed (ii) In clinical settings, patients show wide variation in
in round 7. The mean PDS (at 200 parasites/µL) was 62% parasite density, the range depending on the local
(range, 38–75%) in rounds 2–6 (17 products) and 2.0–88.9% epidemiology of the disease. The parasite density in the
in rounds 2–7. population tested affects the clinical sensitivity of a test.
The PDS against a test panel of blood samples diluted to
Five products tested in round 3 of the programme were 200 parasites/µL is likely to underestimate the clinical
resubmitted for testing in round 7. Two performed better 5 sensitivity of an RDT in areas where symptomatic patients
years after initial testing, but three performed less well, and have much higher parasite densities. Many tests that
two of these no longer met the WHO criteria for procurement. show only moderate detection of the 200-parasites/µL
panel may perform well in such settings, as indicated
The evaluation is performed against a standardized panel of
by the better PDS of most products against the panel at
cultured P. falciparum and frozen blood samples by expe-
2000 parasites/µL. The small differences in PDS seen in
rienced technicians in a research laboratory and is not
Figs S1, S2 and 9–11 and Tables 4 and 5 found among
1
the better-performing RDTs in this evaluation are
The PDS values for P. falciparum in rounds 1, 2, 3, 4 and 5 were
67.2%, 69.9%, 75.5%, 81.6% and 81.0%, respectively.
unlikely to result in noticeable differences in clinical
2 The PDS values for P. vivax in rounds 1, 2, 3 , 4, 5 and 6 were 36.0%, sensitivity, and other issues, such as required storage
58.9%, 47.1%, 51.3%, 61.3% and 70.7%, respectively. conditions, stability, cost, experience and training

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 73
 of the intended users, ease of use (Annex S2) and (v) Diagnostic sensitivity and specificity depend on the
manufacturing capacity, may be equally important quality of preparation and interpretation of the tests.
in test selection. Consideration of the parasite density Highly trained technicians tested all the products in
in target populations and the probable sensitivity of this evaluation. In clinical settings, malaria RDTs are
RDTs in the field indicates that, even in areas with high often used by health workers with limited training
transmission and strong malaria immunity, the popula- and supervision; therefore, simple design and clearly
tion may include individuals with a low parasite density interpretable results are required to ensure translation
but clinically significant infection (e.g. young children, of the technical proficiency of a product into accurate
pregnant women, people who regularly use bed nets, diagnoses in the field (36).
immigrants and people with reduced immunity). The
ability to detect low parasite-density infections reliably,
therefore, remains important. As some countries move
15.2. False-positive rate and
towards elimination of malaria, population immunity specificity
will decrease and/or clinical cases may be detected
False-positive rates are reported against a panel of 52
earlier, and it could become increasingly important to
clean-negative samples taken from blood donated in low-
use diagnostic tests that detect low parasite density (i.e.
transmission settings by people without symptoms of malaria.
with a high PDS against samples with 200 parasites/µL).
In addition, false-positive rates were calculated with a
(iii) The performance of tests against the challenge panel smaller number of samples with specific characteristics
may not always predict sensitivity in clinical testing, e.g. that affect the likelihood of a false-positive result from an
when antigen expression by certain parasite populations immunodiagnostic test (e.g. rheumatoid factor, anti-nuclear
differs greatly from that in the panel. For example, antibody) or that may be significant in a specific population
P. falciparum strains in some areas of Africa (Eritrea (33), in a malaria-endemic area (e.g. leishmaniasis, dengue). The
Democratic Republic of the Congo), India (13) and South importance of these results depends on the intended area
America (34) do not express HRP2 antigens because of of use. High false-positive rates with samples of blood from
gene deletions (12–13). If a significant proportion of dengue patients, for example, might not be a significant factor
parasites in a given area do not express HRP2 and HRP3, in regions in which dengue does not occur. In view of the small
leading to false negative results, tests to detect other number of samples in each category in this evaluation, the
target antigens (e.g. pLDH or aldolase) must be used. results should be considered primarily a guide to potential
To date, parasite populations with a high frequency of cross-reactions, which should be closely monitored if they
non-expression of target antigens have been identified are relevant to the target population.
in several countries in South America (12) and in Eritrea
(33, 34). The reactivity of the non-HRP2, Pf-specific In general, it is preferable to procure a product with a low
test lines against phase 1 and 2 Pf (HRP2-containing) rate of false-positive reactions. In the case of many diagnostic
samples is currently the best predictor of how well these tests, a trade-off must be made between a preference for
RDTs would detect pfhrp2-negative parasites. In most a high rate of antigen detection (sensitivity) and a low
cases, the Pf panel detection score for products based false-positive rate (specificity). The context in which the test
on pf-pLDH-specific test lines is < 75, the cut-off for will be used will guide the relative importance of these two
procurement. In round 7, one combination test met factors in the choice of one product over another. Overall,
the procurement criterion, with a PDS of 75 against in this evaluation, there was no correlation between a lower
200 parasites/µL Pf samples. For a summary of options PDS (loss of sensitivity) and a low false-positive rate (high
and test performance in round 7 and previous rounds, specificity). A number of products had both a high PDS and
refer to the WHO interim guidance on investigating a low false-positive rate.
false-negative RDTs and pfhrp2/3 gene deletions.1
(iv) The conditions under which RDTs are transported and 15.3. Reactivity of combination
stored can alter their sensitivity in the field. The tests
evaluated in round 7 were shipped and stored under
HRP2 and pan-pLDH test lines
conditions intended to safeguard them from degradation against P. falciparum samples
by high temperature or other extreme conditions. If such Instructions for the use of P. falciparum/pan and pan/P. falci-
precautions are not taken with purchased RDTs, loss of parum combination tests classify P. falciparum infections
performance could result. The ambient temperature of as either HRP2 test line-positive alone or in combination
storage conditions varies widely in the settings in which with the pan-pLDH line. Combination tests that return only
these tests are commonly used, as does the temperature a positive HRP2 test line may be incorrectly interpreted as
during transport; therefore, the requirements for the false positives for malaria infection secondary to persistent
heat stability of a product will differ. Tests should be (HRP2) antigenaemia. The results in this report clearly indicate
transported and stored well within the temperature that most combination tests in which HPR2 is used for the
range recommended by the manufacturer (see Annex 1) detection of P. falciparum return positive results only on the
and extremes of temperature avoided (32, 35). HRP2 band at lower densities of P. falciparum (Table A4.2).
1
When both the HRP2 and the pan test bands were positive, the
http://apps.who.int/iris/bitstream/10665/208819/1/WHO_HTM_
mean band intensity was significantly lower on the pan test
GMP_2016.4_eng.pdf (accessed 8 March 2017).

74 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
band than on the HRP2 test band. Therefore, it is important
to reinforce adherence to the manufacturer’s instructions
15.5. Ease-of-use description
for use (Annex 2) and to emphasize that for combination The sensitivity and specificity of RDTs depend on the quality
HRP2/pan-pLDH tests, a HRP2 test line-positive alone may of preparation and interpretation. In general, a simpler format
well be attributed to the poor reactivity of pan-pLDH lines. with fewer steps or fewer required extraneous materials is
likely to be prepared and interpreted more reliably. Thus,
15.4. Heat (thermal) stability cassette-format RDTs are generally more reliably prepared
and interpreted than products in dipstick format (39). The
The RDTs evaluated were held for 2 months at room tempera- extra cost of this format may be offset by the advantages
ture (21–25°C) and at 35°C and 45°C at 75% humidity and of greater accuracy and, in some cases, less additional
tested to evaluate stability at these temperatures as compared equipment required to perform them.
with baseline detection. The importance of thermal stability
depends on the conditions under which a product will be The method by which blood is transferred from the patient
transported and stored. Thus, stability at high temperatures is to the test is important for the safety of the user and for
vital if an RDT is to be stored at clinics in a country where the the accuracy of the volume transferred. Devices for blood
ambient temperature can reach 45°C in the hot season but is transfer are supplied with RDTs but vary widely in design and
less critical in a high-altitude or cooler environment where accuracy (31). The performance of blood transfer devices
the temperature rarely rises above 35°C. Many commercially was not formally assessed in this evaluation, as blood was
available RDTs indicate 30°C or 40°C as the maximal storage transferred from a tube with a micropipette to ensure
temperature (Annex 1). Higher temperatures were tested in that the volume specified by the manufacturer was used.
this evaluation because malaria-endemic countries often Procurement programmes for RDTs should consider the
have maximum ambient temperatures of 35°C, although adequacy of the blood transfer device supplied, including
use of cool storage can allow storage of products below this the experience of health workers and the cost and time
temperature. When RDTs are likely to be transported and required for retraining. It may be appropriate to discuss
stored at high ambient temperatures, heat (thermal) stability with manufacturers the possibility of changing the blood
must be considered a significant factor in ensuring sensitivity. transfer device from that usually supplied.

High humidity accelerates the degradation of malaria RDTs The clarity of results is important for interpreting tests.
and other lateral flow tests. All the products in this evaluation A clearly visible (intense) test line is less likely to be overlooked
were packaged in individual envelopes containing desiccant than a line that is barely visible. While reading proficiency
and designed to be moisture-proof. This allows the user and adequate workplaces should be ensured, some health
to open the envelope of a test at the time of use, limiting workers might have suboptimal vision or work in inadequate
exposure to high humidity. During the stability-testing phase lighting. Although the intensity of the test band was found
of this evaluation, the RDTs were stored at 75% humidity. The to be correlated with the PDS of RDTs, PDS is determined
packaging should, if in good condition, protect the contents only from a positive or negative result under ideal working
from exposure to high humidity during storage. The results conditions. Thus, it is important when selecting RDTs also
presented here provide an assessment of both the stability to consider the relative intensity of the test bands, with a
of the RDT and the quality of its packaging. preference for intense bands (i.e. an intensity > 2).

Several P. falciparum-detecting products were highly stable The importance of format and the simplicity of the test
at the temperatures and times used in the evaluation. In design depend on the intended users. Trained laboratory
this round, as in previous ones, pan-specific lines (pLDH) technicians can handle a complicated procedure more reli-
performed less well at baseline and were less stable than ably than village volunteers with limited supervision. In all
HRP2 test lines, so that it was difficult to assess post- cases, proficiency-based training and adequate supervision
incubation stability. When tested against P. vivax, many of should be included in any RDT-based diagnostic programme,
Discussion

the pan-pLDH lines were highly stable at all temperatures and clear instructions should be provided in a language and
and times tested. In most products, the P. vivax pLDH lines format appropriate for the user (40, 41). Annex S2 provides
were also highly stable. These results for P. vivax are an guidance on conducting a field-based ease-of-use assess-
improvement over round 6. ment (Table AS3.1).

While the temperature and humidity were held constant in

this evaluation, temperatures in the field fluctuate with the
15.6. Labelling and instructions
time of day and season. Two months’ storage at a set tempera- for use
ture cannot accurately predict long-term stability under field
The labelling on primary packaging (the box), device packaging
conditions, but loss of sensitivity for parasite detection over
and the device itself was generally consistent and adhered
this period indicates that significant sensitivity will be lost
to most of the recommendations. A notable exception was
if RDTs are stored at similar or higher temperatures for a
that almost all products failed to include warning labels on
significant period of their storage time and the likelihood of
the boxes and cassette packaging. Much poorer adherence to
greater susceptibility to degradation during short exposure to
the recommendations and less consistency among products
much higher temperatures, such as during transport (37, 38).
was seen in labelling of buffers and other accessories.

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 75
 Adherence to the recommendations for instructions for use manufacturing standards should minimize the likelihood of
was variable. Product information and intended use were inconsistencies due to poor practice in the manufacturing
generally included, with notable exceptions, such as the process. Culture-based panels that are subsets of the phase-1
failure to list all the materials required but not provided. panel used in this evaluation are available as reference
Other aspects of the instructions often did not meet the standards for manufacturers against which to set their
recommendations; for example, the instructions for over one lot-release criteria.1
third of the products did not include precautionary notes on
the use of damaged products or product limitations. With
regard to performance, the instructions for most products
15.9. Selecting RDTs: target antigens,
covered diagnostic sensitivity and specificity, but very few species and sensitivity
included analytical sensitivity and specificity or issues of
parasite density and reference methods. Adherence to the
Target antigens
recommendations for information on procedures was gener- The malaria RDTs evaluated detect one or more of three
ally poor, particularly for safety practices and interpretation: parasite antigens, HRP2, pLDH and aldolase, in various
fewer than half the product instructions advised that a faint combinations. HRP2 is present only in P. falciparum, whereas
line should be considered a positive result. aldolase and pLDH are present in all four species and may
be used as pan or all-species targets. Some tests use differ-
Wide differences in how information is presented to users can ences in pLDH sequences between species as a means to
affect the ease and consistency of use and potentially affect differentiate P. falciparum from P. vivax and other species.
proper use. There is considerable scope for improvement in There is considerable overlap in the PDS of products that
the instructions for use of currently recommended products. target the different antigens in this evaluation. While the
products with the highest PDS for P. falciparum targeted
15.7. Anomalies in RDT production HRP2, a number of pLDH-detecting products had high PDS
against P. vivax. The thermal stability of tests that target
lots these different antigens also overlapped for samples with
Anomalies that affected interpretation of the results were high parasite density.
encountered with variable frequency in the production lots
In choosing an RDT, account should be taken of the target
submitted for evaluation. A glossary of RDT anomalies has
antigen: HRP2-detecting RDTs should not be used in areas
been prepared (Fig. AS2.1) on the basis of the experience of
where false negative RDT rates due to non-expression of
several rounds of product testing, with 4095 lots tested in
HRP2 is common (> 5%) (33, 34). Five P. falciparum RDT prod-
the WHO–FIND lot testing programme. This glossary may
ucts were evaluated in round 7 that detected P. falciparum
be used in RDT training programmes to illustrate potential
with Pf-pLDH, two combination tests had only Pf-pLDH,
problems with some production lots and how to report them
and three had HRP2 as well. Of the three with both HRP2
accurately. As many of the anomalies are infrequent, they
and Pf-pLDH, two combined the two antigens on a single
might not be picked up in manufacturers’ quality control or
test line, and the other had two separate test lines to detect
lot release procedures; therefore, this information is also
P. falciparum. Only one of the three products with separate
useful for manufacturers that wish to improve their processes.
pf-pLDH test lines met WHO procurement criteria with a
P. falciparum PDS of 75% at 200p/µl. However, the pf-pLDH
15.8. Inter-lot variation test lines on all three products performed well at 2000p/µl
(PDS range: 92-100%). Detection of Pf-pLDH is known to be
Only two production lots of each product were evaluated in less sensitive than detection of HRP2 at low parasite densities,
the testing programme. Malaria RDTs are complex biological and low-density infections with HRP2-deleted P. falciparum
products made up of components that are commonly supplied parasites could therefore be missed.
from different sources and are subject to a variety of condi-
tions during manufacture that may affect the quality of the Tests that detect only HRP2 (without pLDH or aldolase
final product. All manufacturers that entered this evaluation lines) will be of limited use where non-falciparum malaria
provided at least one current ISO 13485:2003 certificate for is common. pLDH (and possibly aldolase) RDTs may have
a manufacturing facility. This standard is designed to ensure further advantages when antigen persistence (common with
consistency in the quality of the final product, if correctly HRP2) result in a high false-positive rate in areas where
implemented. The results presented here indicate that inter- early retesting in the weeks immediately after treatment is
lot variation does occur, and WHO strongly recommends that common. As mentioned in section 2.3, however, combination
a sample of RDTs from each production lot be tested before tests with both HRP2 and pan test lines should not be used
their dissemination to the field, to ensure that they meet an for discriminating between acute infection and persistent
appropriate standard. This can be facilitated by WHO through antigenaemia, as the overall reactivity of pan test lines is
two WHO-recognized lot-testing facilities (section 16.2). much lower than that of HRP2 test lines, particularly at low
parasite density.
Inter-test variation will be detected to some extent by
routine lot testing. Ensuring that manufacturers follow good
1 http://www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/

malaria_specimen_bank/en/

76 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Species-specific vs non-species-specific RDTs been commercialized with claims of an analytical sensitivity
of 0.05–0.08 ng/mL of HRP2 (46). This is approximately 10
RDTs are mainly tools for making clinical decisions, but their times the detection limit of the best conventional RDTs that
role in surveillance has grown dramatically. If all infections detect the samples in the product testing panel. (Annex S1).
are managed in the same way, ie. with artemisinin-based The current performance panels cannot discriminate between
combination therapy, there is no clinical advantage of having products that can detect samples with antigen concentrations
an RDT that can distinguish falciparum from non-falciparum comparable to < 200 parasites/µL (considered to be highly
infection: a pan-only test would suffice. If treatment of the sensitive) and those that detect only > 200 parasites/µL
two infections is different, however, distinguishing between (conventional RDTs). Therefore, as expected, the performance
falciparum and non-falciparum infection is a priority, and a of the highly sensitive RDT in round 7 was similar to that of
combination test must be used (Pf/Pan). When the results other high-performing conventional RDT able to detect the
of RDTs are used for species-specific monitoring, a species- majority of clinically significant infections. As for other high
specific RDT is preferable (Pf/Pv). No currently available RDT sensitive tests, the use of the high-sensitive HRP2-based
can specifically identify P. malariae or P. ovale infections. RDT evaluated in round 7 is not recommended for malaria
Furthermore, pan-species and Pvom tests are not evaluated clinical case management, as it is anticipated to lead to the
against these, as there is no source of suitable mono-species problems listed below:
infections. Published data suggest, however, that the sensi-
tivity of RDTs for detecting these species is significantly I) Detection of low levels of HRP2 antigen concentrations
poorer than that for detecting P. falciparum and P. vivax (42). associated with low density falciparum infections may
be associated with decreased specificity of diagnosis
RDT sensitivity and the role of highly of clinical malaria. Since the association between
sensitive diagnostic tools antigenemia and parasitemia and fever varies from place
to place, season to season, their use may potentially lead
RDTs are considered to be tools to detect symptomatic malaria to misdiagnosis and overtreatment of fever, as malaria.
infections, with ≥ 200 parasites/µL (11); however, the threshold
of parasitaemia associated with symptoms depends on both ii) Persistent HRP2 antigenemia over longer period following
transmission intensity and individual immunity to malaria. successful treatment may also cause more false positive
In a review of parasite densities in various epidemiological clinical cases.
settings (43), the best estimate of the proportion of sympto- iii) If highly sensitive diagnostic tests are used for clinical
matic people with a parasite density >200 parasites/µL who case management or surveys, there is a potential threat
seek care at a health facility was 90-95% for P. falciparum of antimalarial stock outs due to increased test positivity
and approximately 85% (range, 78-92%) for P. vivax. The caused by low density, asymptomatic infections.
performance panels used in product testing challenge the RDTs iv) If end-users abruptly see an unexpected increase in the
to consistently detect samples with antigen concentrations number of malaria cases following the introduction of a
at the 200 parasites/µL threshold, corresponding to minimal highly sensitive RDT, this may undermine their confidence
HRP2 antigen concentrations of 0.59-0.80ng/mL and expected in conventional malaria RDTs as case management tools
to detect the majority of clinically symptomatic malaria for acute febrile illness.
infections in endemic settings. The individual and public
health benefits of detecting and treating submicroscopic More research is needed to determine the clinical conse-
or very-low-density parasitaemia are poorly understood quences of submicroscopic infections, their contribution to
and would require rigorous risk-benefit analysis (44,45). onward disease transmission and the role of highly sensi-
Nonetheless, highly sensitive tests like PCR and LAMP have tive diagnostic tests in surveillance for targeting malaria
been used for surveillance and focus investigation in low- elimination.
transmission areas, and a highly sensitive HRP2-based RDT
(Alere™ Malaria Ag Pf (05FK140), Standard Diagnostics) has Discussion

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 77
 16. USING RESULTS TO ENSURE HIGH-
QUALITY DIAGNOSIS IN THE FIELD
This report provides data to guide malaria control programmes
in selecting products that are likely to perform to a high
16.1. WHO prequalification
standard in the context in which the programme operates. The WHO programme for prequalification of in vitro diag-
The report does not provide a list for procurement but should nostics promotes access to good-quality in vitro diagnostic
aid potential buyers by providing comparative data on the tests by applying the principles of a comprehensive regulatory
performance of the available products. Final product selection assessment. This includes inspection of the manufacturer’s
requires that these data be considered systematically, taking quality management system, assessment of technical docu-
into account the distribution of parasite density in the target mentation (dossier review) and an independent performance
population in whom the tests will be used, the experience evaluation.
and training of the intended users and other criteria such as
climate and transport/storage conditions, price and supply The results of the WHO malaria product testing programme
aspects, and others. Box 3 lists WHO’s current minimum fulfill the performance evaluation component of the prequali-
RDT selection criteria, as endorsed by the Malaria Policy fication process. Twelve malaria RDT products have been
Advisory Committee, and Tables S2, S3 and 5 are colour- prequalified.2 Prequalification has not been a requirement
coded to reflect these minimum performance criteria for for eligibility for United Nations procurement tenders for
product selection. As WHO prequalification will become malaria RDTs, as it is for other RDTs, such as for HIV; however,
a requirement as of 1 January 2018, the prequalification WHO prequalification will determine the eligibility of malaria
status of each product is also indicated. A web-based tool RDTs for procurement after 31 December 2017. WHO product
for filtering product testing results by various parameters is testing will continue to be the independent performance labo-
available on the FIND website and has now been updated to ratory evaluation component of the prequalification process.
allow rapid identification of products with the same blood Round 8 of product testing is under way All manufacturers
volume, number of buffer drops and time until reading.1 who submit products to round 8 are required also to submit
Annex 1 groups products according to similar procedure applications for WHO prequalification.
characteristics. Furthermore, an algorithm to guide selection
is given in Annex S3, and detailed guidance was published 16.2. Beyond procurement
by WHO in Recommended selection criteria for procurement
of malaria rapid diagnostic tests, Good practices for selecting Diagnostic tests are usually used at the start of a health
and procuring rapid diagnostic tests for malaria (16) and system intervention, and their use is based on the assumption
Universal access to malaria diagnostic testing (17). that appropriate patient management, based on testing, will
follow. Thus, successful introduction of RDTs requires careful
While malaria RDTs can be used in a number of settings, the planning beyond rational procurement to ensure consistent
greatest impact on public health will ensue from extending supplies of all the necessary materials (including gloves,
access to accurate, parasite-based diagnoses of malaria to sharps disposal containers and supplies required for further
regions and populations where good-quality microscopy- case management), training of users, community sensitization
based analysis is impractical to maintain. This will allow and monitoring of diagnostic quality and results. This extends
implementation of WHO recommendations on universal malaria management to management of other febrile diseases
parasite-based diagnosis before antimalarial therapy (2) and health service delivery systems and requires integration
and currently applies to most people at risk for malaria in with other health programmes.
endemic countries (1). In many settings where RDTs have
been introduced, the true rate of parasitaemia has been While this report does not provide a list for procurement, it
found to be considerably lower than expected, so that health provides information to guide procurement of RDTs within this
systems can reduce wastage of antimalarial medicines and framework. Factors beyond the performance characteristics
focus on appropriate management of non-malarial causes reported here, however, must influence procurement decisions.
of fever, including early pneumonia and sepsis. In order for An example of an algorithm, including an ease-of-use assess-
an RDT programme to have its full potential public health ment, is provided in Annexes S2 and S3 to guide decisions.
impact, it must therefore address not only malaria but also
the management of other common and severe febrile illnesses Details of implementation will vary widely between
that occur locally in the differential diagnosis of malaria (46). programmes, depending on local capacity and needs. Further
recommendations on budgeting, planning and implementation
can be found in Annex 5 and in the relevant WHO guidance
document (17).
1 An interactive guide designed to short-list tests according to
programme needs, based on the performance of tests in rounds 3–6
of the WHO product testing programme can be found at: https:// 2 http://www.who.int/diagnostics_laboratory/evaluations/pq-list/
www.finddx.org/malaria/interactive-guide/ (accessed 8 March 2017). malaria/public_report/en/ (accessed 8 March 2017).

78 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
16.3. Post-market surveillance: purchased performs to a high standard and helps to ensure
that manufacturers produce consistently good lots and
lot verification improve their products. The results support decisions for
accepting or rejecting lots. Lot testing provides information
Post-market surveillance confirms manufacturer compliance
about the adequacy of RDTs for clinical use, their stability
with quality expectations and is an important component of
over their shelf life and any anomalies observed during testing
any quality assurance scheme. Specifically for malaria RDTs,
that may also be encountered in the field.
post-market surveillance ensures that the quality reported in
product testing is found in what is available on the market Countries and manufacturers ship 100–150 RDTs to regional,
to the user. Post-market surveillance can be performed WHO-recognized lot testing centres, where they are evaluated
proactively through lot verification (described next), which is against a small panel of parasites at low density and against
recommended to all procurers, or reactively through comple- negative samples (Fig. 2). They are subsequently incubated at
tion of a “WHO user complaint form for reporting problems a temperature close to the manufacturer’s specified storage
and/or adverse events related to diagnostic products” and temperature and retested 6 months before expiry. Initial
submitted to the following email address: diagnostics@ results are available after 5 days, and definitive results after
who.int. subsequent confirmatory tesing, if required. Details of the
protocol can be found in the methods manual for lot testing
As a complement to product testing, WHO and FIND currently
(27). As lot-to-lot variation has previously been noted in
support laboratories that perform continued quality assur-
many products, purchasers are encouraged to participate
ance of RDTs in the form of lot testing. This programme
in the lot-testing programme to confirm the quality of RDT
responds to requests from all purchasers, including national
lots prior to use. Certain anomalies resulting from defects
malaria programmes, manufacturers and procurement bodies,
in production lots or RDT degradation, or even defects of
to assess the quality of RDT lots before shipment from
some kit accessories, may affect the running of the test or
the production facility or, when they arrive in a country,
interpretation and may warrant a field safety notice and
before distribution to the field and for clinical use. Testing
corrective action. In such instances, a special lot testing
is performed against parasite-positive and -negative panels
service can be provided, which is determined case by case.
prepared and characterized in the same way as the panels
used in this evaluation. A number of national institutions Lot testing is free of charge, but the requester must cover
have also developed this capacity, and, more recently, several shipping costs, including related tax and duties. To access
countries have begun pilot-testing malaria recombinant lot testing through the WHO-FIND programme, contact
antigen panels to monitor trends in lot performance. Lot christian.nsanzabana@finddx.org and cc: Malaria_rdt@
testing reassures countries that the product they have who.int at least 2 weeks before RDTs are ready for shipment.

17. Conclusions

This report adds to the large data set on malaria RDT examining the labelling and instructions for use associated
Discussion
performance published regularly since 2009 (3–8). The with each product in a standardized manner, to demonstrate
product testing programme continues to be an authoritative their performance against a set of standards for these
source in the field of malaria RDT evaluations in terms of components. Publication of the results of past WHO product
the number of products evaluated, its independence and testing rounds has affected the procurement practices of
its comprehensiveness. New laboratory methods have been countries and procurement agencies and contributed to a
developed and validated to support parasite characteriza- shift in the malaria RDT market towards better-performing
tion, and this work has generated new findings on variation products (1, 48). The report of round 7 adds to the number of
in antigen content at similar parasite densities and in the well-performing RDTs for which comprehensive performance
structure and expression of histidine-rich proteins. Round data are now available including the first high-sensitive RDT
7 introduced a new component of the product evaluation: and provides updated data on 15 product resubmissions.

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 79
 18. References
15. Malaria RDT interactive guide. Geneva: Foundation for
Innovative New Diagnostics (https://www.finddx.org/
malaria/interactive-guide/, accessed 8 March 2017).
16. Good practices for selecting and procuring rapid
diagnostic tests for malaria. Geneva: World Health
1. World malaria report 2016. Geneva: World Health Organization; 2011.
Organization; 2016. 17. Universal access to malaria diagnostic testing: an oper-
2. Guidelines for the treatment of malaria. 3rd edition. ational manual. Geneva: World Health Organization;
Geneva: World Health Organization; 2015. 2011(revised 2013).

3. Malaria rapid diagnostic test performance: results of 18. Kolaczinski J, Mohammed N, Ali I, Ali M, Khan N, Ezard
WHO product testing of malaria RDTs: round 1 (2008). N, et al. Comparison of the OptiMAL rapid antigen test
Geneva: World Health Organization; 2009. with field microscopy for the detection of Plasmodium
vivax and P. falciparum: considerations for the appli-
4. Malaria rapid diagnostic test performance: results of cation of the rapid test in Afghanistan. Ann Trop Med
WHO product testing of malaria RDTs: round 2 (2009). Parasitol 2004;98:15–20.
Geneva: World Health Organization; 2010.
19. Richter J, Gobels K, Muller-Stover I, Hoppenheit B,
5. Malaria rapid diagnostic test performance: results Haussinger D. Co-reactivity of plasmodial histidine-
of WHO product testing of malaria RDTs: round 3 rich protein 2 and aldolase on a combined immuno-
(2010–11). Geneva: World Health Organization; 2011. chromographic-malaria dipstick (ICT) as a potential
6. Malaria rapid diagnostic test performance: results of semi-quantitative marker of high Plasmodium falci-
WHO product testing of malaria RDTs: round 4 (2012). parum parasitaemia. Parasitol Res 2004;94:384–385.
Geneva: World Health Organization; 2012. 20. Mai Huong NM, Davis TM, Hewitt S, Huong NV, Uyen
7. Malaria rapid diagnostic test performance: results of TT, Nhan DH, et al. Comparison of three antigen detec-
WHO product testing of malaria RDTs: round 5 (2013). tion methods for diagnosis and therapeutic monitoring
Geneva: World Health Organization; 2014. of malaria: a field study from southern Vietnam. Trop
Med Int Health 2002;7:304–308.
8. Malaria rapid diagnostic test performance: results of
WHO product testing of malaria RDTs: round 6 (2014– 21. Mason DP, Kawamoto F, Lin K, Laoboonchai A,
2015). Geneva: World Health Organization; 2015. Wongsrichanalai C. A comparison of two rapid field
immunochromatographic tests to expert microscopy in
9. Informal consultation on laboratory methods for the diagnosis of malaria. Acta Trop 2002;82:51–59.
quality assurance of malaria rapid diagnostic tests.
Manila: WHO Regional Office for the Western Pacific; 22. van den Broek I, Hill O, Gordillo F, Angarita B, Hamade
2004 (RS/2004/GE/26(PHL). P, Counihan H, et al. Evaluation of three rapid tests
for diagnosis of P. falciparum and P. vivax malaria in
10. Prequalification of in vitro diagnostics. Geneva: World Colombia. Am J Trop Med Hyg 2006;75:1209–1215.
Health Organization (http://www.who.int/diagnostics_
laboratory/evaluations/en/, accessed 8 March 2017). 23. McMorrow M, Masanja MI, Abdulla SM, Kahigwa
E, Kachur SP. Challenges in routine implementation
11. Parasitological confirmation of malaria diagnosis. and quality control of rapid diagnostic tests for
Report of a WHO technical consultation. Geneva, 6–8 malaria – Rufiji District, Tanzania. Am J Trop Med Hyg
October 2009. Geneva: World Health Organization; 2008;79:385–390.
2010.
24. Wanji S, Kimbi HK, Eyong JE, Tendongfor N,
12. Gamboa D, Ho MF, Bendezu J, Torres K, Chiodini PL, Ndamukong JL. Performance and usefulness of the
Barnwell JW, et al. A large proportion of P. falciparum Hexagon rapid diagnostic test in children with asymp-
isolates in the Amazon region of Peru lack pfhrp2 and tomatic malaria living in the Mount Cameroon region.
pfhrp3: implications for malaria rapid diagnostic tests. Malar J 2008;7:89.
PLoS One 2010:5:e8091.
25. Willcox ML, Sanogo F, Graz B, Forster M, Dakouo F,
13. Bharti PK, Chandel HS, Ahmad A, Krishna S, Sidibe O, et al. Rapid diagnostic tests for the home-
Udhayakumar V, Singh N. Prevalence of pfhrp2 and/or based management of malaria, in a high-transmission
pfhrp3 gene deletion in Plasmodium falciparum popu- area. Ann Trop Med Parasitol 2009;103:3–16.
lation in eight highly endemic states in India. PLoS One
2016;11:e0157949. 26. Belizario VY, Pasay CJ, Bersabe MJ,de leon WU,
Guererro DM, Bugaoisan VM. Field evaluation of
14. Jacobs J, Barbé B, Gillet P, Aidoo M, Serra-Casas E, Van malaria rapid diagnostic tests for the diagnosis
Erps J, et al. Harmonization of malaria rapid diagnostic of P. falciparum and non-P. falciparum infec-
tests: best practices in labelling including instructions tions. Southeast Asian J Trop Med Public Health
for use. Malar J 2014;13:505. 2005;36:552–561.

80 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
27. Methods manual for laboratory quality control testing dehydrogenase-based and histidine-rich protein
of malaria rapid diagnostic tests, version 8. Geneva: 2-based malaria rapid diagnostic tests. Trans R Soc
World Health Organization; 2016. Trop Med Hyg 2007;101:331–337.
28. Methods manual for product testing of malaria rapid 39. Rennie W, Phetsouvanh R, Lupisan S, Vanisaveth V,
diagnostic tests (version 6). Geneva: World Health Hongvanthong B, Phompida S, et al. Minimising human
Organization; 2014. error in malaria rapid diagnosis: clarity of written
instructions and health worker performance. Trans R
29. Call for expressions of interest for round 7 of the
Soc Trop Med Hyg 2007;101:9–18.
WHO Malaria Rapid Diagnostic Test Product Testing
Programme (http://www.who.int/malaria/news/2015/ 40. Harvey SA, Jennings L, Chinyama M, Masaninga F,
rdt_call_for_testing_round7/en/ (accessed 10 March Mulholland K, Bell DR. Improving community health
2017). worker use of malaria rapid diagnostic tests in Zambia:
package instructions, job aid and job aid-plus-training.
30. Baker J, Ho MF, Pelecanos A, Gatton M, Chen N,
Malar J 2008;7:160.
Abdullah S, et al. Global sequence variation in the
histidine-rich proteins 2 and 3 of Plasmodium falci- 41. Tavrow P, Knebel E, Cogswell L. Using quality design to
parum: implications for the performance of malaria improve malaria rapid diagnostic tests in Malawi. In:
rapid diagnostic tests. Malar J 2010;9:129. Operations research results 1(4). Bethesda, MD: United
States Agency for International Development; 2000.
31. Hopkins H, Oyibo W, Luchavez J, Mationg ML, Asiimwe
C, Albertini A, et al. Blood transfer devices for malaria 42. Heutmekers M, Gillet P, Maltha J, Scheirlinck A, Cnops
rapid diagnostic tests: evaluation of accuracy, safety L, Bottieau E, et al. Evaluation of the rapid diagnostic
and ease of use. Malar J 2011;10:30. test CareStart pLDH Malaria (Pf-pLDH/panpLDH) for
the diagnosis of malaria in a reference setting. Malar J
32. Methods for field trials of malaria rapid diagnostic
2012;11:204.
tests. Manila: World Health Organization Regional
Office for the Western Pacific; 2009. 43. Parasitological confirmation of malaria diagnosis:
WHO technical consultation, Geneva, 6–8 October
33. Berhane A, Mihreteab S, Mohammed S, Embaye G,
2009. Geneva: World Health Organization; 2009.
Hagos F, Zehaie A, et al. PfHRP2 detecting malaria
RDTs: alarming false negative results in Eritrea. Poster 44. Lindblade KA, Steinhardt L, Samuels A, Kachur SP,
879. In: 65th annual meeting of the American Society Slutsker L. The silent threat: asymptomatic parasitemia
for Tropical Medicine and Hygiene. Oakbrook Terrace, and malaria transmission. Expert Rev Anti-infect Ther
IL; 2016. 2013;11:623–639.
34. Cheng Q, Gatton M, Barnwell J, Chiodini P, McCarthy 45. Chen I, Clarke SE, Gosling R, Hamainza B, Killeen G,
J, Bell D, et al. Plasmodium falciparum parasites et al. (2016) “Asymptomatic” Malaria: A Chronic and
lacking histidine-rich protein 2 and 3: a review and Debilitating Infection That Should Be Treated. PLOS
recommendations for accurate reporting. Malaria J Medicine 13(1): e1001942. 
2014;13:283.
46. Malaria Ag P.f Ref: 05Fk140. Instructions for use. San
35. Transporting, storing and handling malaria rapid diag- Diego, CA: Alere.
nostic tests at central and peripheral storage facilities.
47. D’Acremont V, Kilowoko M, Kyungu E, Philipina S,
Manila: World Health Organization Regional Office for
Sango W, Kahama-Maro J, et al. Beyond malaria –
the Western Pacific; 2009.
causes of fever in outpatient Tanzanian children. N
36. Training materials for the use of malaria RDTs. Geneva: Engl J Med. 2014;370:809–817.
Foundation for Innovative Diagnostics; 2011 (http://
Discussion
48. Incardona S, Serra-Casas E, Champouillon N,
www.who.int/malaria/areas/diagnosis/rapid-diag-
Nsanzabana C, Cunningham J, Gonzalez IJ. Global
nostic-tests/job-aids/en/, accessed 10 March 2017).
survey of malaria rapid diagnostic test (RDT) sales,
37. Jorgensen P, Chanthap L, Rebueno A, et al., Malaria procurement and lot verification practices: assessing
rapid diagnostic tests in tropical climates: the need for the use of the WHO-FIND Malaria RDT Evaluation
a cool chain. Am J Trop Med Hyg 2006;74(5):750–754. Programme (2011–2014). Malaria Journal 2017; 16:196
38. Chiodini PL, Bowers K, Jorgensen P, Tsuyuoka R,
Bell D. The heat stability of Plasmodium lactate

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 81
82 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 Annexes

Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 83
 Annex S1: Characteristics of Figure AS1.1: Box-and-whisker plot of distribution of
evaluation panels used in rounds P. falciparum HRP2 concentration (ng/mL) in product
testing phase 2 (wildtype) panels.
1–7 of WHO malaria RDT product Round 7
testing, 2008–2016 Round 6
Currently, the basis for diagnosing malaria with antigen- Round 5
detecting RDTs is the detection in a patient’s blood of one Round 4
or more target malaria antigens, including HRP2 (P. falci-
Round 3
parum only), pLDH (Plasmodium spp.pan-pLDH), P. falciparum
(Pf-pLDH), non-falciparum (Pv-pLDH, Pvom-pLDH) and Round 2
aldolase (all Plasmodium spp). The antigen concentration in Round 1
samples with the same parasite density varies. Therefore, 0.5 1 2 4 8 16 32 64 128
the concentrations of malaria antigens in the samples that P. falciparum HRP2 concentration (ng/ml)
comprise evaluation panels must be consistent in successive
rounds of WHO malaria RDT product testing to ensure that
Figure AS1.2: Box-and-whisker plot of distribution of
the results of each round are highly comparable (statistically P. falciparum pLDH concentration (ng/mL) in product
equivalent). testing phase 2 (wildtype) panels.
Therefore, antigen concentrations were quantified in triplicate Round 7
in all panel samples, including dilution pairs of 200 and Round 6
2000 parasites/µL, by quantitative ELISA. Only results that
Round 5
were consistent in the triplicate runs and showed a value
factor between the 200 and the 2000 parasites/µL dilutions Round 4
close to 10 were considered acceptable and eligible for the Round 3
performance evaluation panel. In some instances, the antigen Round 2
concentration was below the detection limit of the ELISA,
Round 1
particularly for aldolase, which is present in malaria parasite
samples at much lower concentrations than the other two 0.25 0.5 1 2 4 8 16 32 64
antigens. Samples that gave inconsistent results for more P. falciparum pLDH concentration (ng/ml)
than one of the three antigens were excluded from the panel.
Figure AS1.3: Box-and-whisker plot of distribution of
Despite careful standardization of procedures, the tables and P. vivax pLDH concentration (ng/mL) in product testing
figures below show a wide variation in antigen concentra- phase 2 (wild-type) panels.
tions for the same parasite density. There are a number of
possible explanations, including differences in the level of Round 7
antigen expression by isolates; different durations of infection Round 6
(accumulating antigens); different parasite growth stages at Round 5
the time of collection (expressing different levels of antigen);
Round 4
the presence of circulating HRP2 from previous growth
cycles; and HRP2 produced by parasites sequestered in the Round 3
host’s vascular tissues that cannot be accounted for in the Round 2
estimate of parasite density on the blood slide. Round 1

Before each round of WHO malaria RDT product testing, the 1 2 4 8 16 32 64

distribution of HRP2, pLDH and aldolase concentrations at P. vivax pLDH concentration (ng/ml)
200 parasites/µL dilution of the wild-type P. falciparum and
wild-type P. vivax samples selected for the phase-2 panels Figure AS1.4: Box-and-whisker plot of distribution of
were systematically compared with those in the previous P. falciparum aldolase concentration (ng/mL) in product
testing phase 2 (wild-type) panels.
round to ensure there was no statistically significant differ-
ence. The figures and tables below show the distribution of Round 7
antigen concentrations in all six performance evaluation
Round 6
panels. No statistically significant differences were seen
Round 5
(Kruskal-Wallis test; p > 0.5), confirming that the results
of each new round are additive (and comparable) to the Round 4
previous ones. In the following box and whisker plots, the Round 3
end of whiskers represent minimum and maximum values; Round 2
the box represents middle 50% of data and the line through Round 1
box represents median values; the crosses represent the
0.125 0.25 0.5 1 2 4 8 16
mean values.
P. falciparum aldolase concentration (ng/ml)

84 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 Figure AS1.5: Box-and-whisker plot of distribution
of P. vivax aldolase concentration (ng/mL) in product
testing phase 2 (wild-type) panels.
Round 7
Round 6
Round 5
Round 4
Round 3
Round 2
Round 1

1 2 4 8 16
P. vivax aldolase concentration (ng/ml)

Table AS1.1: Statistics for P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5 Round 6 Round 7
Number of valuesa 78 99 99 98 99 99 99
Minimum 0.80 0.62 0.62 0.62 0.59 0.67 0.67
25% percentile 2.90 1.90 2.10 2.97 2.15 2.48 2.15
Median 9.57 6.76 6.83 6.98 6.76 8.12 6.76
75% percentile 18.94 16.91 17.37 15.65 15.31 15.51 16.99
Maximum 73.70 73.70 66.70 62.48 62.48 62.48 62.48
Mean 15.28 12.70 12.77 12.72 11.65 12.15 11.83
Std. Deviation 16.98 15.75 15.19 14.72 13.25 13.29 13.01
a The number of values is the number of samples for which consistent ELISA results were obtained.

Table AS1.2: Statistics for P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5 Round 6 Round 7
Number of valuesa 74 93 92 92 94 98 98
Minimum 0.71 0.19 0.19 0.19 0.19 0.19 0.19
25% percentile 6.68 6.27 6.23 6.20 6.90 7.04 7.20
Median 11.95 10.31 11.18 10.92 12.24 11.85 12.99
75% percentile 23.75 20.10 22.70 21.28 23.05 20.36 21.51
Maximum 47.15 47.15 47.15 53.53 43.02 53.53 53.53
Mean 15.31 13.71 15.08 14.97 15.53 15.61 15.93
Std. Deviation 11.47 10.90 11.72 11.98 11.43 12.00 11.60
a The number of values is the number of samples for which consistent ELISA results were obtained.

Table AS1.3: Statistics for P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5 Round 6 Round 7
Number of valuesa 20 37 33 32 34 34 35
Minimum 5.10 1.64 1.64 1.64 1.64 1.64 1.64
25% percentile 8.10 8.40 7.30 6.96 6.26 6.72 6.86
Median 12.65 17.00 19.78 17.50 13.22 15.17 16.62
75% percentile 27.40 29.69 31.89 29.84 23.42 23.14 22.89
Annexes

Maximum 44.40 47.90 47.90 47.90 47.90 44.79 44.79

Mean 17.38 20.24 20.99 20.00 16.84 16.90 16.87
Std. Deviation 11.57 13.27 13.55 13.00 12.59 11.78 11.17
a The number of values is the number of samples for which consistent ELISA results were obtained.

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 85
 Table AS1.4: Statistics for P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5 Round 6 Round 7
Number of valuesa 77 98 99 97 98 99 99
Minimum 0.00 0.00 0.00 0.00 0.00 0.00 0.00
25% percentile 0.84 0.74 0.67 0.64 0.52 0.44 0.59
Median 1.58 1.49 1.40 1.25 1.17 1.18 1.25
75% percentile 2.25 2.25 2.23 2.25 2.07 2.02 1.88
Maximum 9.90 9.90 9.90 9.08 7.74 9.08 9.08
Mean 1.93 1.79 1.76 1.72 1.52 1.50 1.43
Std. Deviation 1.73 1.66 1.69 1.68 1.52 1.61 1.34
a The number of values is the number of samples for which consistent ELISA results were obtained.

Table AS1.5: Statistics for P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.
Round 1 Round 2 Round 3 Round 4 Round 5 Round 6 Round 7
Number of valuesa 20 40 34 33 35 35 35
Minimum 3.21 1.70 1.70 1.70 3.21 1.70 3.21
25% percentile 4.02 4.11 4.07 4.41 5.55 4.94 5.27
Median 6.33 6.15 6.10 6.16 6.86 6.54 7.96
75% percentile 8.47 8.47 8.32 9.10 9.43 9.68 10.52
Maximum 13.15 13.40 13.30 15.00 15.00 15.08 15.08
Mean 6.73 6.81 6.45 6.86 7.78 7.74 8.22
Std. Deviation 2.89 3.15 2.90 3.23 3.30 3.69 3.61
a The number of values is the number of samples for which consistent ELISA results were obtained.

86 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annex S2: Malaria RDT field assessment and anomalies
Fig. AS2.1 shows examples of observations and anomalies encountered and routinely recorded for RDTs in round 7 of WHO
Malaria RDT Product Testing at the CDC. Most of these anomalies would not invalidate the results, as reactivity in the control
and test line areas is still visible, but they may pose challenges to health workers in interpreting the results. Furthermore,
they should be reported to manufacturers.

An extended list of notable observations on RDT packaging, kit accessories (buffer vials, desiccants) and instructions for
use is being prepared for use in both product testing and lot testing in the WHO-FIND Malaria RDT Evaluation Programme.
Table AS2.1: Field assessment of RDT packaging, safety and ease-of-use to guide product selection
Date of assessment
Commercial name
Product code
Lot number(s)
Yes No NA Problems /Comments
Packaging and accessories
The RDT box is in good condition
RDTs are in individual sealed package
The correctly indicated number of RDTs are in the box
Desiccant is included in each individual RDT package
An expiry date is visible on each RDT package
All required accessories are included in the correct quantities If no, what is not included:
(RDT, buffer, blood transfer device, alcohol swab,
lancet, gloves, test tubes (for dipsticks, only)
Instructions
Instructions are included
Instructions are in the national language(s)
The instructions are for the correct product
The instructions include figures displaying
all possible interpretations of the RDT results
The text and figures are accurate and consistent
(specifically order of test lines and results interpretation)
Preparation and procedure
The test package is easy to open
It is easy to write on the test device
The test lines on the device are clearly labelled
It is easy to use the device for blood collection
It is easy to open the buffer bottle or vial
The buffer bottle or vial have sufficient volume
for testing all RDTs in the box
The buffer bottle or vial dispenses even drops
It is easy to fill the sample well correctly with the provided blood
transfer device
It is easy to fill the buffer well correctly (no overflow)
The buffer and sample flow well along the test strip
Result interpretation
Control and test lines
Control line is clear
Test line(s) are clear
If no, number of tests in the box affected:
Good clearance of blood by time of reading
Steps and reading time
Reading time <30 min
Two or fewer timed steps
Was one or more of the last 10 tests
you performed invalid (no control line)?
If YES, how many?
Annexes

Safety
Are there mixing wells (risk of blood splash)?
Retractable needle for finger prick?
Is the RDT in a cassette format (unexposed strip)?
Have waste disposal safety concerns been addressed?
(If no, please describe)
NA, not applicable

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 87
 Figure AS2.1 illustrates examples of RDT observations/anomalies encountered and routinely recorded during round 6 of
WHO Malaria RDT Product Testing at the CDC. In most cases, these anomalies do not invalidate the results, as reactivity
in the control and test line areas are still visible, but they may pose challenges to health workers interpreting the results.
Furthermore, they should be reported to manufacturers.

An expanded list of notable observations concerning RDT packaging, kit accessories (buffer vials, desiccants) and instruc-
tions for use, is under development for use in both product testing and lot testing activities of the WHO-FIND Malaria RDT
Evaluation Programme.

Figure AS2.1: Malaria RDT anomalies encountered in production lots

a) Observations on the test strip

Red background C T1 T2 Background staining is relatively common.
In this example, the result is positive as test
lines are positive; however, a more intense
red background may obscure weak positive
test lines, giving false-negative results.
Incomplete clearing In this example, the result is positive as
C T the test line is visible.
Poor clearing of blood may obscure weak
positive test lines, giving false-negative
results.

b) Observations of flow problems

Failed migration Blood and buffer did not run the length
C T of the strip

Incomplete migration One portion of the nitrocellulose near the

C T1 test band was not absorptive and remained
dry during wicking, creating irregular migra-
tion of blood/buffer with red background.
In this example, the result is positive, as the
test line is clearly visible.

c) Observations on test lines

Ghost test lines White lines on a stained background. In this
C T1 T2 T3
example, the result is negative, as the test
line is not dark and is thus not visible.

Patchy broken test The test line is visible but interrupted

C T1 T2
line(s) (broken).

Diffuse test line(s) Test line wider than control, without

C T clearly defined edge.

88 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
d) RDT structural problems
Strip misplaced in the Strip can be seen only partially in the
cassette (shift) results window.

Specimen pad not seen Normally, the colour of the conjugated

in sample window C T1 T2 antibody can be seen in the sample


window (commonly purple, pink or blue).

Buffer remains pooled in The buffer is not completely absorbed

the buffer well and this may result in failed migration or
incomplete clearing.

Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 89
 Annex S3: Selection of an appropriate RDT
Figure AS3.1: How to select of an appropriate RDT
Step 1.1 What? target parasite species and antigena
Define setting of use Pf-only or mixed Pf and non-Pf infections (single species)b: P. vivax, only:
Pf/non-Pf infections: - HRP2, aldolase; HRP2, pLDH-pan - aldolase
- HRP2 - HRP2, pLDH-Pv; HRP2, pLDH-Pvom - pLDH-pan
- pLDH-Pf; pLDH-pan - HRP2, pLDH-pan; pLDH-Pv - pLDH-Pv
- pLDH-Pf, pLDH-pan; pLDH-Pf, pLDH-Pv
- pLDH-Pf, pLDH-Pvom
**Pf without HRP2 – Do not use exclusively HRP2-based RDTsc

Where? Exposure to high temperature e.g. tropical environment

OR
temperature-controlled environment, including during
transport and storage
Who? Laboratory personnel
OR
health workers outside laboratories

Step 1.2 WHO RDT product testing resultsd and apply WHO recommended RDT selection
Review RDT performance criteriae
- Panel detection score
- False-positivity rate
- Invalid rate
- Ease-of-use
- Thermal stability
Sensitivity and specificity based on high-quality
field studies in relevant populations

Generate short-list of RDTs

Step 1.3 National malaria treatment guidelines

Apply national guidelines
and experience in use of RDTs
In-country experience, ease-of-use assessments (Annex S2),
availability of training materials

Step 1.4 - Price

Other considerations - Manufacturer: production capacity, lead times, heat stability data and storage conditions
- Delivery schedules (e.g. staggered deliveries), box size, shelf life
- Registration requirements of national regulatory authorities
- Product lot testing results
- Overall budget requirements (Annex 5)
a Pf-only or mixed Pf/non-Pf infections: Most areas of sub-Saharan Africa and lowland Papua New Guinea; Pf and non-Pf infections (single species): Most endemic
areas of Asia and the Americas and isolated areas of the Horn of Africa; Mainly P. vivax-only: areas of East Asia, central Asia, South America, and some highland areas
elsewhere
b Tests with a P. falciparum-specific line and pan-specific line will not distinguish P. falciparum-only infections from mixed P. falciparum infections. Distinguishing
P. falciparum from mixed P. falciparum-vivax infections is important only if a full course of primaquine is routinely given for infections due to P. vivax. This must
be weighed against the loss of ability to detect P. malariae and P. ovale if a test has only P. falciparum- and P. vivax-specific lines. Inclusion of further test lines
(e.g. Pf-Pv-pan-pLDH) to detect these increases the complexity of test interpretation. A programme should prioritize these various advantages and disadvantages
according to local conditions in the initial stage of making procurement decisions.
c P. falciparum parasites lacking HRP2 +/- HRP3 genes have been identified with high frequency in parts of South America, Africa (Eritrea, Democratic Republic of the
Congo, Ghana) and India (1–6).
d See references (7–12).
e WHO RDT procurement criteria (13) : http://www.who.int/malaria/publications/atoz/rdt_selection_criteria/en/ (accessed 14 June 2017).

For a comprehensive guide to procurement of malaria RDTs extending beyond selection to quantification, budgeting, technical
specifications, management of tenders, contracts, supply management and monitoring of supplier performance and managing
product variations, see reference in the full report (16).

90 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 Annex 1: Characteristics of RDTs evaluated in round 7
Sequence and type
of bound antibodyb

C T1 T2 T3
Required Recom-
volume Minimum Maximum Results mended
of whole Buffer time to reading Protocol Interpreta- Format storage
blood drops resultsc time groupf tiond typee temperature Shelf-life
Manufacturer Product name Product code C T1 T2 T3 (µl) (mins) (mins) (type A-J) (°Celcius) (months)
Access Bio, Inc. CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RMVM-05072 Pv pLDH HRP2 5 2 20 1 E Cassette 1-40 24
Access Bio, Inc. CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line RMSM-05071 Pf pLDH HRP2 5 2 20 1 J Cassette 1-40 24
HRP2 +
Access Bio, Inc. CareStart™ Malaria Screen RMAM-05071 Pan pLDH 5 2 20 1 C Cassette 1-40 24
Pf pLDH
Access Bio, Inc. CareStart™ Pf/PAN (pLDH) Ag RDT RMLM-05071 Pan pLDH Pf pLDH 5 2 20 1 C Cassette 4-30 24
Access Bio Ethiopia CareStart™ Malaria HRP2 (Pf) RMOM-03091 HRP2 5 2 20 1 A Cassette 1-40 36
Access Bio Ethiopia CareStart™ Malaria HRP2/pLDH (Pf/Pv) Combo RMVM-03091 Pv pLDH HRP2 5 2 20 1 E Cassette 1-40 36
Advy Chemical Private Limited Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Pan pLDH HRP2 5 4 20 30 3 C Cassette 2-40 24
Advy Chemical Private Limited Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 HRP2 5 4 20 30 3 A Cassette 2-40 24
Alere Medical Private Limited Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Pan pLDH HRP2 5 4 30 30 5 C Cassette 1-40 24
Alere Medical Private Limited SD Bioline Malaria Ag Pf/Pv 05FK80I-40 Pv pLDH HRP2 5 4 30 30 5 E Cassette 1-40 24
ALLDIAG SA PALUTOP +4 optima® 5499 Pan pLDH Pv pLDH HRP2 5 2 20 30 1 G Cassette 4-30 24
ALLDIAG SA PALUTOP + pf® 5531 HRP2 5 2 20 30 1 A Cassette 4-45 24
ARKRAY Healthcare Pvt Ltd Parahit® f Ver 1.0 - Device 55IC104-50 HRP2 8 4 25 30 9 A Cassette 4-40 24
ARKRAY Healthcare Pvt Ltd Parahit f® Ver 1.0 - Dipstick 55IC103-50 HRP2 8 4 25 30 9 A Dipstick 4-40 24
ASAN Pharmaceutical Co., Ltd Asan Easy Test® Malaria Pf/Pan Ag AM4650-K Pan pLDH HRP2 5 4 30 30 5 C Cassette 1-30 24
Aspen Laboratories Pvt. Ltd. Aspen® Malaria Ag Pf/Pv AS0060 Pan pLDH HRP2 5 3 20 30 2 C Cassette 2-40 24
Aspen Laboratories Pvt. Ltd. Aspen® Malaria Ag Pf AS0015 HRP2 5 3 20 30 2 A Cassette 2-40 24
Bio Focus Co., Ltd. BioTracer™ Malaria P.f Rapid Card 17912 HPR2 5 4 20 20 3 A Cassette 1-40 24
Bio Focus Co., Ltd. BioTracer™ Malaria P.f/PAN Rapid Card 17012 Pan pLDH HPR2 5 4 20 20 3 C Cassette 1-40 24
Biosynex Biosynex® Malaria Pf/Pv 0581_K25 Pv pLDH HRP2 5 4 15 30 7 E Cassette 2-30 24
Biosynex Biosynex® Malaria Pf/Pan 0584_K25 Pan pLDH HRP2 5 4 15 30 7 C Cassette 2-30 24
DIALAB DIAQUICK Malaria P.f. Cassette W06200 HRP2 5 4 20 30 3 A Cassette 2-30 24
Guangzhou Wondfo Biotech Co., Ltd. One Step Malaria HRP2 (P.f) Test W37-C HRP2 5 4 15 30 7 A Cassette 1-35 24
Guangzhou Wondfo Biotech Co., Ltd. One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Pv pLDH HRP2 5 4 15 30 7 E Cassette 1-35 24
Hangzhou AllTest Biotech Co. Ltd. AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Aldolase HRP2 5 3 10 20 10 C Cassette 2-30 24
Hema Diagnostic Systems Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 HRP2 Pan pLDH 5 3 20 30 2 D Cassette 4-30 24
ICT INTERNATIONAL ICT MALARIA DUAL TEST ML03 HRP2 Pan pLDH 5 5 30 30 11 D Cassette 4-40 24
ICT INTERNATIONAL ICT MALARIA P.F. CASSETTE TEST ML01 HRP2 5 5 15 12 A Cassette 4-40 24
InTec Products, Inc. ADVANCED QUALITY ™ ONE STEP Malaria (p.f) Test ITP11002-TC25 HRP2 5 3 20 2 A Cassette 2-40 24
InTec Products, Inc. ADVANCED QUALITY ™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 Pv pLDH HRP2 5 3 20 2 E Cassette 2-40 24
Lumiquick Diagnostics Inc. QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Pv pLDH HRP2 5 3 20 2 E Cassette 4-30 18

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Medical Diagnostech (Pty) Ltd MD Malaria Pf MDMALPFH005 HRP2 5 4 30 5 A Cassette 4-40 24
Medical Diagnostech (Pty) Ltd MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 HRP2 Pv pLDH 5 4 30 5 F Cassette 4-40 24
(continued)

Annexes

91
 92
Annex 1: Characteristics of RDTs evaluated in round 6 (continued)
Sequence and type
of bound antibodyb

C T1 T2 T3
Required Recom-
volume Minimum Maximum Results mended
of whole Buffer time to reading Protocol Interpreta- Format storage
blood drops resultsc time groupf tiond typee temperature Shelf-life
Manufacturer Product name Product code C T1 T2 T3 (µl) (mins) (mins) (type A-J) (°Celcius) (months)
Medsource Ozone Biomedicals Pvt. Ltd. Is It... Malaria Pf PAN MPFPAN050 Pan pLDH HRP2 5 3 20 25 2 C Cassette 2-40 24
Meril Diagnostics Pvt. Ltd. One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Pv pLDH HRP2 5 4 20 30 3 E Cassette 2-30 18
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria
Meril Diagnostics Pvt. Ltd. MPHRPD-01 HRP2 5 4 20 30 3 A Cassette 2-30 18
Pf HRP-II Ag
NG Biotech NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL- W23-005 HRP2 Pan pLDH 5 4 30 30 5 D Cassette 2-40 24
RapiGEN Inc. BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 Pan pLDH HRP2 5 4 30 30 5 C Cassette 1-40 24
RapiGEN Inc. BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 Pv pLDH Pf pLDH 5 4 30 30 5 E Cassette 1-40 24
Shanghai Kehua Bio-engineering Co., Ltd. KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C HRP2 5 4 15 20 7 A Cassette 4-30 24
HRP2 + Pf
Standard Diagnostics, Inc. SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 5 4 15 7 A Cassette 1-40 24
pLDH
Standard Diagnostics, Inc. Alere™ Malaria Ag P.f 05FK140-40-0 HRP2 5 4 20 3 A Cassette 1-30 12
WELLS BIO, INC careUS™ Malaria Pf (HRP2) Ag RMO-M05082 HRP2 5 2 20 1 A Cassette 1-40 42
WELLS BIO, INC careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 Pv pLDH HRP2 5 2 20 1 E Cassette 1-40 24
Zhejiang Orient Gene Biotech Co., Ltd. Malaria Pf Rapid Test GCMAL(pf)-402a HRP2 5 3 20 30 2 A Cassette 2-30 24
Zhejiang Orient Gene Biotech Co., Ltd. Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a HRP2 Pv pLDH 5 3 20 30 2 F Cassette 2-30 24
a pLDH , plasmodium lactate dehydrogrenase; HRP2, histidine rich protein 2; e Formats include: cassette (A); card (B); hybrid (C), dipstick (D); or other (E). Each f Products have been assigned into different groups based on their procedural
pv, P. vivax; pf, P. falciparum product should ideally be accompanied by all required materials (lancet, pipette, characteristics, specifically, blood volume (µL), number of buffer drops and minimum
b Sequence when test held in a horizontal position and the sample well is at the far etc.) particularly when used at the village health worker level; however, this is often reading time (minutes). The groups are as follows: group 1: 5µL, 2 drops, 20 mins; group 2:
right and control line, far left not the case and the contents depend on the request of the procuring agent. 5µL, 3 drops, 20 mins; group 3: 5µL, 4 drops, 20 mins; group 4: 5µL, 2 drops, 30 mins;
c From placement of buffer, or from ‘intermediate’ step, if applicable group 5: 5µL, 4 drops, 30 mins; group 6: 5µL, 3 drops, 15 mins; group 7: 5µL, 4 drops,
d See Annex 2 15 mins; group 8: 10µL, 3 drops, 10 mins; group 9: 8µL, 4 drops, 25 mins; group 10:
5µL, 3 drops, 10 mins ; group 11: 5µL, 5 drops, 30 mins; group 12: 5µL, 5 drops, 15 mins.

A Cassette B Card C Cassette hybrid D Dipstick E Other

C T S A
C
T1

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
T2 Pf P C

 
C

C T S
T1

Sample and
T2

mixing wells
Annex 2: Malaria RDTs: guide to interpretation of results

Type A: Guide to results of generic Pf malaria RDTs

Results window: C=control line; T=test line with bound HRP2 or Pf-specific pLDH antibody.

C T

Negative results: One line ‘C’ appears in the results window.

C T

Positive results: P. falciparum infection. Two lines ‘C’ and ‘T’ appear in the results window.
Test is positive even if the test line is faint.

C T

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T C T

Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 93
 Type B: Guide to results of generic major Plasmodium species (pan) malaria RDTs
Results window: C=control line; T=test line with bound pan-specific pLDH or aldolase antibody.

C T

Negative results: One line ‘C’ appears in the results window.

C T

Positive results: P lasmodium species (P. falciparum, P. vivax, P. malariae, P. ovale) infection. Two lines ‘C’ and ‘T’ appear in
the results window. Test is positive even is the test line is faint.
C T

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.
C T C T

94 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Type C: Guide to results of generic pan-Pf malaria RDTs
Results window: C=control line; T1=test line with bound pLDH or aldolase antibody; T2=test line with bound HRP2
and/or Pf-specific pLDH antibody.

C T1 T2

Negative results: Only one line ‘C’ appears in the results window.

C T1 T2

Positive results:
P. falciparum: Two lines ‘C’ and ‘T2” appear in the results window.

C T1 T2

Non-falciparum infection (P. vivax, P. ovale, P. malariae) or mixed infection:

Two lines ‘C’ and ‘T1” appear in the results window.

C T1 T2

P. falciparum or mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T1 T2 C T1 T2

C T1 T2 C T1 T2

Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 95
 Type D: Guide to results of generic Pf-pan malaria RDTs
Results window: C=control line; T1=test line with bound HRP2 or Pf-specific LDH antibody;
T2=test line with bound pLDH or aldolase antibody.

C T1 T2

Negative results: Only one line ‘C’ appears in the results window.

C T1 T2

Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2

Non-falciparum infection (P. vivax, P. ovale, P. malariae) or mixed infection.

Two lines ‘C’ and ‘T2’ appear in the results window.

C T1 T2

P. falciparum or mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T1 T2 C T1 T2

C T1 T2 C T1 T2

96 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Type E: Guide to results of generic Pv-Pf malaria RDTs
Results window: C=control line; T1=test line with bound P. vivax-specific pLDH;
T2=test line with bound HRP2 or Pf-specific pLDH antibody.

C T1 T2

Negative results: Only one line ‘C’ appears in the results window.

C T1 T2

Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window.

C T1 T2

P. vivax infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2

P. falciparum and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T1 T2 C T1 T2

C T1 T2 C T1 T2

Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 97
 Type F: Guide to results of generic Pf-Pv malaria RDTs
Results window: C=control line; T1= test line with bound HRP2 or Pf-specific pLDH antibody;
T2=test line with bound P. vivax-specific pLDH.

C T1 T2

Negative results: Only one line ‘C’ appears in the results window.

C T1 T2

Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2

P. vivax infection. Two lines ‘C’ and ‘T2’ appear in the results window.

C T1 T2

P. falciparum and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T1 T2 C T1 T2

C T1 T2 C T1 T2

98 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Type G: Guide to results of generic pan-Pv-Pf malaria RDTs
Results window: C=control line; T1=test line with bound pLDH or aldolase antibody; T2=test line with bound P. vivax-specific
pLDH; T3=test line with bound HRP2 or Pf-specific pLDH antibody

C T1 T2 T3

Negative results: Only one line ‘C’ appears in the results window.

C T1 T2 T3

Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T3’ appear in the results window.

C T1 T2 T3

P. vivax infection. Two lines ‘C’ and ‘T2’ appear in the results window.

C T1 T2 T3

P. falciparum with or without mixed infection with P. ovale or P. malariae. Three lines ‘C’, ‘T1’ and ‘T3’ appear in the results window.

C T1 T2 T3

P. falciparum and P. vivax mixed infection. Three lines ‘C’, ‘T2’ and ‘T3’ appear in the results window.

C T1 T2 T3

P. falciparum and P. vivax mixed infection with or without P. ovale and/or P. malariae infection.
Four lines ‘C’, ‘T1’, ‘T2’ and ‘T3’ appear in the results window.

C T1 T2 T3
Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 99

P. vivax with or without P. ovale and/or P. malariae infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results
window.

C T1 T2 T3

P. malariae with or without P. ovale and/or P. vivax infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2 T3

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T1 T2 T3 C T1 T2 T3

C T1 T2 T3 C T1 T2 T3

C T1 T2 T3 C T1 T2 T3

C T1 T2 T3 C T1 T2 T3

10 0 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Type H: Guide to results of generic vom1-Pf malaria RDTs
Results window: C=control line; T1= test line with bound pLDH specific for non-P. falciparum (P. vivax, P. ovale and P. malariae);
T2=test line with bound HRP2 or Pf-specific pLDH antibody

C T1 T2

Negative results: Only one line ‘C’ appears in the results window.

C T1 T2

Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window.

C T1 T2

P. falciparum mixed infection (with P. vivax, P. ovale and/or P. malariae). Three lines ‘C’, ‘T1’ and ‘T2’ appear in the
results window.

C T1 T2

Non-P. falciparum infection (P. vivax, P. ovale and P. malariae) or mixed infection. Two lines ‘C’ and ‘T1’ appear in the
results window.

C T1 T2

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T1 T2 C T1 T2

C T1 T2 C T1 T2

Annexes

1 vom, P. vivax, P. ovale, P. malariae

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 101
 Type I: Guide to results of generic Pv malaria RDTs
Results window: C=control line; T=test line with bound P. vivax-specific pLDH.

C T

Negative results: Only one line ‘C’ appears in the results window.

C T

Positive results: P . vivax infection. Two lines ‘C’ and ‘T’ appear in the results window.

C T

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T C T

10 2 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Type J: Guide to results of generic Pf-Pf malaria RDTs
Results window: C=control line; T1= test line with bound pLDH specific for P. falciparum;
T2=test line with bound HRP2.

C T1 T2

Negative results: Only one line ‘C’ appears in the results window.

C T1 T2

Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2

P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window.

C T1 T2

P. falciparum infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T1 T2 C T1 T2

C T1 T2 C T1 T2

Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 103
 Type K: Guide to results of generic Pv-Pf-Pf malaria RDTs
Results window: C=control line; T1= test line with bound P. vivax-specific pLDH; T2=test line with bound HRP2 or Pf-specific
pLDH antibody; T3=test line with bound HRP2 or Pf-specific pLDH antibody. If an RDT has bound HRP2
antibodies on T2, T3 will have bound Pf-specific pLDH and vice versa (T2 Pf antigen target ≠ T3 Pf antigen
target).

C T1 T2 T3

Negative results: Only one line ‘C’ appears in the results window.

C T1 T2 T3

Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T3’ appear in the results window.

C T1 T2 T3

P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window.

C T1 T2 T3

P. falciparum infection. Three lines ‘C’, ‘T2’ and ‘T3’ appear in the results window.

C T1 T2 T3

P. falciparum infection and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2 T3

P. falciparum infection and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T3’ appear in the results window.

C T1 T2 T3

10 4 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 P. falciparum infection and P. vivax mixed infection. Four lines ‘C’, ‘T1’, ‘T2’ and ‘T3’ appear in the results window.

C T1 T2 T3

P. vivax infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2 T3

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T1 T2 T3 C T1 T2 T3

C T1 T2 T3 C T1 T2 T3

C T1 T2 T3 C T1 T2 T3

C T1 T2 T3 C T1 T2 T3

Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 105
 Type L: Guide to results of generic pan-Pf-Pf malaria RDTs
Results window: C=control line; T1= test line with bound PAN-pLDH or aldolase antibody; T2=test line with bound HRP2 or
Pf-specific pLDH antibody; T3=test line with bound HRP2 or Pf-specific pLDH antibody. If an RDT has bound
HRP2 antibodies on T2, T3 will have bound Pf-specific pLDH and vice versa (T2 Pf antigen target ≠ T3 Pf
antigen target)

C T1 T2 T3

Negative results: Only one line ‘C’ appears in the results window.

C T1 T2 T3

Positive results:
P. falciparum infection. Two lines ‘C’ and ‘T2’ appear in the results window.

C T1 T2 T3

P. falciparum infection. Two lines ‘C’ and ‘T3’ appear in the results window.

C T1 T2 T3

P. falciparum infection. Three lines ‘C’, ‘T2’ and ‘T3’ appear in the results window.

C T1 T2 T3

P. falciparum infection with or without mixed infection with P. vivax, P. ovale and/or P. malariae.
Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2 T3

P. falciparum infection with or without mixed infection with P. vivax, P. ovale and/or P. malariae.
Three lines ‘C’, ‘T1’ and ‘T3’ appear in the results window.

C T1 T2 T3

10 6 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 P. falciparum infection with or without mixed infection with P. vivax, P. ovale and/or P. malariae.
Four lines ‘C’, ‘T1’, ‘T2’ and ‘T3’ appear in the results window.

C T1 T2 T3

Non-P. falciparum infection (P. vivax, P. ovale, P. malariae) or mixed infection.

Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2 T3

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T1 T2 T3 C T1 T2 T3

C T1 T2 T3 C T1 T2 T3

C T1 T2 T3 C T1 T2 T3

C T1 T2 T3 C T1 T2 T3

Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 107
 10 8
Annex 3: Phase-1 results
Table A3.1: Lot variability in positive resultsa against phase-1 P. falciparum culture samples at low (200) and high (2000) parasite density (parasites/µL)
P. falciparum samples (n=20)
Total positive results returned
200 parasites/µL 2000 parasites/µL
Product Product code Manufacturer
Lot 1 Lot 2 Lot 1 Lot 2
No. positive No. positive
Test 1 Test 2 agreementsb Test 1 Test 2 agreementsb Test 1 Test 2
(max=20) (max=20)
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 20 20 20 20 20 20 20 20
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 20 20 20 20 20 20 20 20
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 20 20 20 20 20 20 20 20
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 20 20 20 20 20 20 20 20
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 20 20 20 20 20 20 20 20
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 20 20 20 20 20 20 20 20
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line RMSM-05071 Access Bio, Inc. 20 20 20 20 20 20 20 20
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 20 20 20 20 20 20 20 20
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 20 20 20 20 20 20 20 20
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 20 20 20 20 20 20 20 20
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 20 20 20 20 20 20 20 20
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 20 20 20 20 20 20 20 20
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 20 20 20 20 20 20 20 20
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 20 20 20 20 20 20 20 20
One Step Test for Malaria Pf HRP-II Ag
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 20 20 20 19 20 19 20 20
MERISCREEN Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 20 20 20 20 20 20 20 20
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 18 19 17 19 20 19 20 20
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 20 20 20 20 20 20 20 20
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 18 20 18 20 20 20 20 20

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 20 18 18 17 18 16 20 19 (19)
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 20 20 20 20 20 20 20 20
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 18 16 16 20 19 19 20 20
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 20 20 20 20 20 20 20 20
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 20 20 20 18 18 16 20 20
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 20 20 20 20 20 20 20 20
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 20 20 20 20 20 20 20 20
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 20 20 20 20 20 20 20 20
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 20 20 20 20 20 20 20 20
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 20 20 20 20 20 20 20 20
 Table A3.1 (continued)
P. falciparum samples (n=20)
Total positive results returned
200 parasites/µL 2000 parasites/µL
Product Product code Manufacturer
Lot 1 Lot 2 Lot 1 Lot 2
No. positive No. positive
Test 1 Test 2 agreementsb Test 1 Test 2 agreementsb Test 1 Test 2
(max=20) (max=20)
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 20 20 20 20 20 20 20 20
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 20 20 20 20 20 20 20 19
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 20 20 20 20 20 20 20 20
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 20 20 20 20 20 20 20 20
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 18 (19) 19 (19) 17 (18) 18 17 16 20 20
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 20 20 20 20 20 20 20 20
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 20 20 20 20 20 20 20 20
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 20 20 20 20 20 20 20 20
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 20 20 20 20 20 20 20 20
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 20 20 20 20 20 20 20 20
Malaria Pf/PAN Test PROPMALPFPV001 Real World Diagnostics 20 20 20 20 20 20 20 20
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 20 20 20 20 20 20 20 20
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 19 (19) 20 19 (19) 18 20 18 20 20
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 20 20 20 20 20 20 20 20
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 20 20 20 20 20 20 20 20
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 20 20 20 20 20 20 20 20
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species 
a Results are based on the first reader’s interpretation according to manufacturer’s instructions.
b Number of samples that returned a positive result for both tests. Where one test was invalid and the other positive, positive agreement was recorded.

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

109
 11 0
Table A3.2: Distribution of test band intensity (0-4) scores against phase-1 P. falciparum cultured parasites at low (200) and high (2000) parasite density (parasites/μl)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl

Product Product Manufacturer Percentage distribution of Pf Percentage distribution of Pf Percentage distribution of pan Percentage distribution of pan
code test band intensityb (n=80) test band intensityb (n=40) test band intensityb (n=80) test band intensityb (n=40)
0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 0.0 26.3 61.3 12.5 0.0 0.0 0.0 2.5 42.5 55.0 NA NA NA NA NA NA NA NA NA NA
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 0.0 7.5 52.5 30.0 10.0 0.0 0.0 0.0 7.5 92.5 NA NA NA NA NA NA NA NA NA NA
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 0.0 0.0 8.8 41.3 50.0 0.0 0.0 0.0 0.0 100.0 NA NA NA NA NA NA NA NA NA NA
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 0.0 7.5 65.0 21.3 6.3 0.0 0.0 7.5 20.0 72.5 NA NA NA NA NA NA NA NA NA NA
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 0.0 0.0 25.0 53.8 21.3 0.0 0.0 0.0 0.0 100.0 NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 0.0 0.0 18.8 43.8 37.5 0.0 0.0 0.0 0.0 100.0 NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line
- HRP2 band 0.0 1.3 38.8 43.8 16.3 0.0 0.0 0.0 2.5 97.5 NA NA NA NA NA NA NA NA NA NA
RMSM-05071 Access Bio, Inc.
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line 38.8 48.8 12.5 0.0 0.0 2.5 17.5 77.5 2.5 0.0 NA NA NA NA NA NA NA NA NA NA
- Pf-pLDH band
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 0.0 0.0 17.5 48.8 33.8 0.0 0.0 0.0 2.5 97.5 NA NA NA NA NA NA NA NA NA NA
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 0.0 16.3 70.0 11.3 2.5 0.0 0.0 0.0 20.0 80.0 NA NA NA NA NA NA NA NA NA NA
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 0.0 0.0 47.5 40.0 12.5 0.0 0.0 0.0 5.0 95.0 NA NA NA NA NA NA NA NA NA NA
Shanghai Kehua Bio-engineering
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C 0.0 10.0 61.3 25.0 3.8 0.0 0.0 0.0 7.5 92.5 NA NA NA NA NA NA NA NA NA NA
Co., Ltd.
GCMAL(pf)-
Malaria Pf Rapid Test Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 50.0 40.0 10.0 0.0 0.0 0.0 7.5 92.5 NA NA NA NA NA NA NA NA NA NA
402a
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 0.0 6.3 48.8 30.0 15.0 0.0 0.0 0.0 22.5 77.5 NA NA NA NA NA NA NA NA NA NA
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 11.3 61.3 26.3 1.3 0.0 0.0 2.5 27.5 70.0 NA NA NA NA NA NA NA NA NA NA
One Step Test for Malaria Pf HRP-II Ag MERISCREEN
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 1.3 43.8 51.3 3.8 0.0 0.0 2.5 5.0 42.5 50.0 NA NA NA NA NA NA NA NA NA NA
Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 0.0 0.0 41.3 42.5 16.3 0.0 0.0 0.0 0.0 100.0 NA NA NA NA NA NA NA NA NA NA
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 5.0 45.0 48.8 1.3 0.0 0.0 0.0 10.0 25.0 65.0 NA NA NA NA NA NA NA NA NA NA
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 0.0 36.3 58.8 5.0 0.0 0.0 2.5 5.0 30.0 62.5 NA NA NA NA NA NA NA NA NA NA
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 2.5 2.5 65.0 28.8 1.3 0.0 0.0 2.5 20.0 77.5 NA NA NA NA NA NA NA NA NA NA
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 8.8 45.0 43.8 2.5 0.0 2.5 0.0 17.5 30.0 50.0 98.8 1.3 0.0 0.0 0.0 17.5 77.5 5.0 0.0 0.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/
05FK60AI-40 Alere Medical Private Limited 0.0 1.3 58.8 31.3 8.8 0.0 0.0 0.0 7.5 92.5 76.3 23.8 0.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0
Pan (HRP-II/pLDH)
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0.0 12.5 70.0 16.3 1.3 0.0 0.0 0.0 27.5 72.5 96.3 3.8 0.0 0.0 0.0 5.0 72.5 22.5 0.0 0.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0.0 6.3 57.5 26.3 10.0 0.0 0.0 0.0 5.0 95.0 56.3 43.8 0.0 0.0 0.0 0.0 20.0 80.0 0.0 0.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 5.0 5.0 62.5 21.3 6.3 0.0 0.0 10.0 10.0 80.0 41.3 57.5 1.3 0.0 0.0 0.0 7.5 92.5 0.0 0.0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0.0 0.0 28.8 47.5 23.8 0.0 0.0 0.0 0.0 100.0 50.0 48.8 1.3 0.0 0.0 0.0 2.5 97.5 0.0 0.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0.0 12.5 70.0 16.3 1.3 0.0 0.0 0.0 27.5 72.5 96.3 3.8 0.0 0.0 0.0 0.0 50.0 50.0 0.0 0.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 0.0 0.0 41.3 45.0 13.8 0.0 0.0 0.0 5.0 95.0 31.3 68.8 0.0 0.0 0.0 0.0 0.0 95.0 5.0 0.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0.0 0.0 45.0 36.3 18.8 0.0 0.0 0.0 0.0 100.0 8.8 83.8 7.5 0.0 0.0 0.0 0.0 60.0 40.0 0.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 0.0 2.5 48.8 30.0 18.8 0.0 0.0 0.0 5.0 95.0 96.3 3.8 0.0 0.0 0.0 17.5 67.5 15.0 0.0 0.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 0.0 2.5 57.5 30.0 10.0 0.0 0.0 0.0 5.0 95.0 20.0 77.5 2.5 0.0 0.0 0.0 2.5 97.5 0.0 0.0
 Table A3.2 (continued)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl

Product Product Manufacturer Percentage distribution of Pf Percentage distribution of Pf Percentage distribution of pan Percentage distribution of pan
code test band intensityb (n=80) test band intensityb (n=40) test band intensityb (n=80) test band intensityb (n=40)
0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4
NGB-MAL-
NG-Test MALARIA Pf/Pan (pLDH) NG Biotech 0.0 1.3 43.8 31.3 23.8 2.5 0.0 0.0 2.5 95.0 38.8 51.3 8.8 1.3 0.0 2.5 22.5 75.0 0.0 0.0
W23-005
MAL-PF/Pan-
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN Hema Diagnostic Systems 0.0 0.0 40.0 40.0 20.0 0.0 0.0 0.0 0.0 100.0 81.3 18.8 0.0 0.0 0.0 0.0 15.0 85.0 0.0 0.0
CAS/25
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.)
ITP11003-TC25 InTec Products, Inc. 0.0 5.0 61.3 28.8 5.0 0.0 0.0 2.5 5.0 92.5 NA NA NA NA NA NA NA NA NA NA
Tri-line Test
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 10.0 62.5 26.3 1.3 0.0 0.0 0.0 32.5 65.0 2.5 NA NA NA NA NA NA NA NA NA NA
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0.0 8.8 73.8 16.3 1.3 0.0 0.0 0.0 15.0 85.0 NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0.0 2.5 52.5 28.8 16.3 0.0 0.0 0.0 7.5 92.5 NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0.0 5.0 58.8 23.8 12.5 0.0 0.0 0.0 5.0 95.0 NA NA NA NA NA NA NA NA NA NA
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0.0 0.0 50.0 28.8 21.3 0.0 0.0 0.0 2.5 97.5 NA NA NA NA NA NA NA NA NA NA
GCMAL(pf/pv)-
Malaria Pf/Pv Rapid Test Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 48.8 41.3 10.0 0.0 0.0 0.0 5.0 95.0 NA NA NA NA NA NA NA NA NA NA
402a
Malaria Pf/PAN Test PROPMALPFPV001 Real World Diagnostics 0.0 0.0 50.0 33.8 16.3 0.0 0.0 0.0 7.5 92.5 NA NA NA NA NA NA NA NA NA NA
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 11.3 62.5 23.8 2.5 0.0 0.0 2.5 25.0 72.5 NA NA NA NA NA NA NA NA NA NA
One Step Test for Malaria Pf/Pv Ag MERISCREEN
MFLRPD-02 Meril Diagnostics Pvt. Ltd. 3.8 22.5 60.0 13.8 0.0 0.0 2.5 5.0 42.5 50.0 NA NA NA NA NA NA NA NA NA NA
Malaria Pf/Pv Ag
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 0.0 12.5 63.8 23.8 0.0 0.0 0.0 0.0 30.0 70.0 NA NA NA NA NA NA NA NA NA NA
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline
11108191040 Alere Medical Private Limited 0.0 0.0 61.3 30.0 8.8 0.0 0.0 0.0 7.5 92.5 NA NA NA NA NA NA NA NA NA NA
Malaria Ag Pf/Pv
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0.0 0.0 41.3 43.8 15.0 0.0 0.0 0.0 5.0 95.0 22.5 72.5 5.0 0.0 0.0 0.0 0.0 70.0 30.0 0.0
NA, not applicable
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species 
a Denotes no band visible
b Calculations include invalid tests

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

111
 11 2
Annex 4: Phase-2 results
Table A4.1: Lot variation in positive results against phase-2 wild-type P. falciparum and P. vivax samples at low (200) and high (2000) parasite density (parasites/µL)
P. falciparum samples (n=100) P. vivax samples (n=35)
Total positive resultsa returned Total positive resultsa returned
200 parasites/µL 2000b 200 parasites/µL 2000
Product Product Manufacturer parasites/μl parasites/μl
code
Lot 1 Lot 2 Lot 1 Lot 2 Lot 1 Lot 2 Lot 1 Lot 2
No. positive No. positive No. positive No. positive
Test 1 Test 2 agreementsc Test 1 c
Test 2 agreements Test 1 Test 2 Test 1 Test 2 agreementsc Test 1 c
Test 2 agreements Test 1 Test 2
(max=100) (max=100) (max=35) (max=35)
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen
RKMAL017 Advy Chemical Private Limited 87 89 87 84 85 81 100 100 NA NA NA NA NA NA NA NA
Detection Test
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 98 97 95 97 98 96 100 99 NA NA NA NA NA NA NA NA
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 100 99 99 98 100 98 100 100 NA NA NA NA NA NA NA NA
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 98 98 97 96 97 95 100 100 NA NA NA NA NA NA NA NA
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 100 99 99 99 98 97 99 100 NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 98 99 97 99 99 98 100 100 NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo
RMSM-05071 Access Bio, Inc. 95 96 94 98 99 98 99 100 NA NA NA NA NA NA NA NA
3-Line
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 98 98 96 98 98 97 100 100 NA NA NA NA NA NA NA NA
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 93 90 88 91 92 88 99 100 NA NA NA NA NA NA NA NA
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 97 96 95 99 97 97 100 100 NA NA NA NA NA NA NA NA
Shanghai Kehua Bio-engineering
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C 94 90 87 91 90 87 100 99 NA NA NA NA NA NA NA NA
Co., Ltd.
GCMAL(pf)- Zhejiang Orient Gene Biotech
Malaria Pf Rapid Test 96 93 91 96 95 93 100 100 NA NA NA NA NA NA NA NA
402a Co., Ltd.
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 88 (99) 90 87 (99) 92 90 88 100 99 NA NA NA NA NA NA NA NA
Guangzhou Wondfo Biotech
One Step Malaria HRP2 (P.f) Test W37-C 97 96 96 97 95 94 100 100 NA NA NA NA NA NA NA NA
Co., Ltd.
One Step Test for Malaria Pf HRP-II Ag MERISCREEN
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 79 87 78 83 84 79 99 100 NA NA NA NA NA NA NA NA
Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 95 95 93 100 98 98 99 100 NA NA NA NA NA NA NA NA
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 84 81 77 82 86 80 100 100 NA NA NA NA NA NA NA NA

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 83 87 80 85 84 81 100 100 NA NA NA NA NA NA NA NA
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 96 94 94 94 94 92 100 100 NA NA NA NA NA NA NA NA
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 81 77 75 77 77 73 100 100 24 26 22 29 23 21 35 35
Alere Trueline™ – Rapid test kit for Malaria Ag
05FK60AI-40 Alere Medical Private Limited 90 90 88 92 89 88 99 99 35 35 35 32 35 32 35 35
Pf/Pan (HRP-II/pLDH)
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 78 76 73 78 83 76 98 97 28 32 28 29 30 27 35 35
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 93 (99) 93 89 (99) 94 95 (99) 93 (99) 99 99 35 35 35 35 35 35 35 35
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 98 (99) 98 97 (99) 95 98 94 98 100 33 34 32 (34) 34 (34) 35 34 (34) 35 35
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 92 (99) 93 90 (99) 94 94 93 100 99 35 35 35 35 35 35 35 35
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 90 91 89 88 87 85 100 100 34 34 33 33 32 31 35 35
 Table A4.1 (continued)
P. falciparum samples (n=100) P. vivax samples (n=35)
Total positive resultsa returned Total positive resultsa returned
200 parasites/µL 2000b 200 parasites/µL 2000
Product Product Manufacturer parasites/μl parasites/μl
code
Lot 1 Lot 2 Lot 1 Lot 2 Lot 1 Lot 2 Lot 1 Lot 2
No. positive No. positive No. positive No. positive
Test 1 Test 2 agreementsc Test 1 c
Test 2 agreements Test 1 Test 2 Test 1 Test 2 agreementsc Test 1 c
Test 2 agreements Test 1 Test 2
(max=100) (max=100) (max=35) (max=35)
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 99 97 97 97 98 97 99 100 35 34 34 35 35 35 34 34
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 87 85 78 90 88 83 100 100 2 1 0 1 1 0 29 26
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 97 96 95 97 97 96 99 100 35 35 35 35 33 33 35 34
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 94 92 90 92 89 87 99 99 21 21 17 17 19 15 35 35
Medsource Ozone Biomedicals
Is It... Malaria Pf PAN MPFPAN050 98 95 95 95 95 94 99 100 35 35 35 35 35 35 35 35
Pvt. Ltd.
NGB-MAL-
NG-Test MALARIA Pf/Pan (pLDH) NG Biotech 97 97 95 95 (99) 95 93 (99) 99 99 24 22 (34) 16 (34) 25 20 18 33 34
W23-005
MAL-PF/Pan-
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN Hema Diagnostic Systems 96 95 94 97 94 93 100 100 35 35 35 35 35 35 35 35
CAS/25
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.)
ITP11003-TC25 InTec Products, Inc. 99 97 96 97 94 93 100 98 35 35 35 34 35 34 35 34 (34)
Tri-line Test
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 85 (99) 89 (99) 82 (98) 88 88 82 97 (99) 99 35 34 (34) 34 (34) 35 35 35 35 33 (33)
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 94 89 89 92 86 86 99 100 34 35 34 33 34 32 35 34 (34)
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag
RMVM-03091 Access Bio Ethiopia 96 98 95 97 96 95 100 100 35 34 34 35 35 35 35 35
Combo RDT
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag.
RMVM-05072 Access Bio, Inc. 94 91 90 98 95 95 99 100 35 35 35 35 35 35 35 35
Combo RDT
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 97 97 94 96 97 95 100 100 35 35 35 33 33 31 35 35
GCMAL(pf/pv)- Zhejiang Orient Gene Biotech
Malaria Pf/Pv Rapid Test 96 94 92 94 93 90 99 (99) 99 33 30 29 27 29 23 35 35
402a Co., Ltd.
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 90 (99) 90 88 (99) 90 90 87 100 99 7 4 1 11 7 5 6 6
Guangzhou Wondfo Biotech
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C 94 97 94 96 95 94 100 100 30 30 28 29 29 27 35 35
Co., Ltd.
One Step Test for Malaria Pf/Pv Ag MERISCREEN
MFLRPD-02 Meril Diagnostics Pvt. Ltd. 85 85 82 85 83 80 100 100 34 33 33 31 34 31 35 35
Malaria Pf/Pv Ag
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 91 91 87 87 86 83 100 99 34 35 34 31 35 31 35 35
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline
11108191040 Alere Medical Private Limited 92 93 91 89 88 86 99 99 35 32 32 34 32 32 35 35
Malaria Ag Pf/Pv
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 94 93 92 96 94 94 99 100 30 32 30 32 33 31 35 35
NA, not applicable
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species
a Results are based on the first reader’s interpretation according to manufacturer’s instructions.
b 3 (3%) of the 100 P. falciparum high parasite density dilution samples were at 5000 parasites/µL rather than 2000
c Number of samples that returned a positive result for both tests. Where one test was invalid and the other positive, positive agreement was recorded.
d Results presented in the table are based on a positive Pf test line (either HRP2 or Pf-pLDH).

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

113
 11 4
Table A4.2: Distribution of test band intensity scores (0-4) against phase-2 wild-type P. falciparum samples at low (200) and high (2000) parasite density (parasites/µl)
200 parasites/µl 2000b parasites/μl 200 parasites/µl 2000b parasites/μl 200 parasites/µl 2000b parasites/μl
Percentage distribution Percentage distribution Percentage distribution of Percentage distribution of Percentage distribution Percentage distribution
Product Product code Manufacturer of Pf test band intensityc of Pf test band intensityc pan test band intensityc pan test band intensityc of Pv test band intensityc of Pv test band intensityc
(n=400) (n=200) (n=400) (n=200) (n=400) (n=200)
0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Advy Chemical Private
RKMAL017 13.8 25.0 34.0 21.8 5.5 0.0 1.5 18.5 24.0 56.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Detection Test Limited
ADVANCED QUALITY™ ONE STEP
ITP11002-TC25 InTec Products, Inc. 2.5 14.0 39.5 29.8 14.3 0.5 1.5 5.0 24.0 69.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Malaria (p.f) Test
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 0.8 4.5 22.5 28.8 43.5 0.0 0.5 0.0 9.0 90.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 2.8 20.5 38.8 31.0 7.0 0.0 0.5 11.0 27.0 61.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 1.0 10.8 27.3 37.3 23.8 0.5 0.0 2.5 22.5 74.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 1.3 9.0 26.8 26.8 36.3 0.0 0.0 2.5 13.5 84.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf (HRP2/pLDH) Ag
Combo 3-Line - HRP2 band 3.0 15.0 26.0 28.3 27.8 0.5 0.0 4.0 14.5 81.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf (HRP2/pLDH) Ag RMSM-05071 Access Bio, Inc.
46.8 34.5 18.8 0.0 0.0 5.0 30.5 63.5 1.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Combo 3-Line - Pf-pLDH band
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 2.0 7.5 26.8 26.3 37.5 0.0 0.5 1.0 10.0 88.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 8.5 25.0 40.3 21.5 4.8 0.5 1.0 16.5 26.0 56.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 2.8 13.3 31.8 29.0 23.3 0.0 0.0 4.0 19.5 76.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Shanghai Kehua Bio-
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C 8.8 18.8 28.3 29.8 14.5 0.5 1.0 7.5 18.5 72.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
engineering Co., Ltd.
GCMAL(pf)- Zhejiang Orient Gene
Malaria Pf Rapid Test 5.0 15.5 35.8 25.3 18.5 0.0 0.0 9.5 20.0 70.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
402a Biotech Co., Ltd.
Medical Diagnostech 9.8 12.0 29.6 29.8 18.8
GMD Malaria Pf test GMDMALPF001 0.5 0.5 6.5 26.0 66.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
(Pty) Ltd (399) (399) (399) (399) (399)
Guangzhou Wondfo
One Step Malaria HRP2 (P.f) Test W37-C 3.8 18.8 38.5 30.8 8.3 0.0 0.5 7.5 30.0 62.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Biotech Co., Ltd.
One Step Test for Malaria Pf HRP-II Ag
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 16.8 27.0 35.5 17.5 3.3 0.5 2.0 21.0 28.0 48.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
MERISCREEN Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 3.0 12.3 29.3 28.5 27.0 0.5 0.5 4.5 18.0 76.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 16.8 33.3 33.8 14.5 1.8 0.0 4.0 22.5 25.5 48.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 15.3 33.8 33.8 15.5 1.8 0.0 4.5 22.5 25.0 48.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH)
05FK130-40-0 Standard Diagnostics, Inc. 5.5 18.5 35.3 33.8 7.0 0.0 0.5 11.0 27.0 61.5 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
2 Lines
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Advy Chemical Private
RKMAL016 22.0 27.3 36.5 13.0 1.3 0.0 5.5 22.0 24.5 48.0 95.8 4.3 0.0 0.0 0.0 16.5 58.5 25.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA
Detection Kit Limited
Alere Trueline™ – Rapid test kit for Malaria Alere Medical Private
05FK60AI-40 9.8 14.0 31.8 36.0 8.5 1.0 0.5 9.5 28.5 60.5 50.3 44.8 5.0 0.0 0.0 3.0 10.0 67.5 19.5 0.0 NA NA NA NA NA NA NA NA NA NA
Ag Pf/Pan (HRP-II/pLDH) Limited
AllTest™ Malaria P.f./Pan Rapid Test Hangzhou AllTest Biotech
IMPN-402 21.3 29.8 40.0 8.8 0.3 2.5 3.0 26.0 33.5 35.0 79.3 20.0 0.8 0.0 0.0 6.0 38.5 51.5 4.0 0.0 NA NA NA NA NA NA NA NA NA NA
Cassette Co. Ltd.
ASAN Pharmaceutical 5.8 22.6 26.3 32.3 13.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K 1.0 1.0 7.5 20.0 70.5 42.0 52.0 6.0 0.0 0.0 2.5 10.0 67.5 19.0 1.0 NA NA NA NA NA NA NA NA NA NA
Co., Ltd (399) (399) (399) (399) (399)
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 2.8 20.3 40.3 28.0 8.8 1.0 0.5 10.5 25.0 63.0 28.0 58.5 13.5 0.0 0.0 2.0 6.0 75.0 15.0 2.0 NA NA NA NA NA NA NA NA NA NA
 Table A4.2 (continued)
200 parasites/µl 2000b parasites/μl 200 parasites/µl 2000b parasites/μl 200 parasites/µl 2000b parasites/μl
Percentage distribution Percentage distribution Percentage distribution of Percentage distribution of Percentage distribution Percentage distribution
Product Product code Manufacturer of Pf test band intensityc of Pf test band intensityc pan test band intensityc pan test band intensityc of Pv test band intensityc of Pv test band intensityc
(n=400) (n=200) (n=400) (n=200) (n=400) (n=200)
0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4
6.5 11.3 25.6 27.8 28.8
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0.5 0.5 4.0 16.5 78.5 52.3 41.5 6.3 0.0 0.0 3.5 16.5 62.0 18.0 0.0 NA NA NA NA NA NA NA NA NA NA
(399) (399) (399) (399) (399)
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 11.0 23.5 36.0 23.3 6.3 0.0 2.5 12.0 23.5 62.0 81.8 18.0 0.3 0.0 0.0 5.0 39.0 53.0 3.0 0.0 NA NA NA NA NA NA NA NA NA NA
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 2.3 10.3 25.8 39.5 22.3 0.5 0.0 3.5 23.0 73.0 14.8 62.5 22.8 0.0 0.0 2.0 2.0 50.0 40.5 5.5 NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 12.5 45.3 35.5 6.8 0.0 0.0 1.0 38.0 42.0 19.0 87.0 13.0 0.0 0.0 0.0 9.0 58.5 32.5 0.0 0.0 NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 3.3 14.0 26.3 26.5 30.0 0.5 0.0 3.0 13.0 83.5 9.8 55.8 33.8 0.8 0.0 1.0 1.0 43.5 45.5 9.0 NA NA NA NA NA NA NA NA NA NA
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 8.3 14.3 32.8 25.0 19.8 1.0 1.0 5.0 21.0 72.0 81.5 15.8 2.8 0.0 0.0 4.5 36.0 55.0 4.5 0.0 NA NA NA NA NA NA NA NA NA NA
Medsource Ozone
Is It... Malaria Pf PAN MPFPAN050 4.3 17.5 28.3 32.3 17.8 0.5 1.0 3.5 22.5 72.5 14.5 74.0 11.5 0.0 0.0 2.0 3.5 70.0 22.5 2.0 NA NA NA NA NA NA NA NA NA NA
Biomedicals Pvt. Ltd.
NGB-
NG-Test MALARIA Pf/Pan (pLDH) NG Biotech 4.0 15.5 31.3 31.8 17.5 1.0 0.5 4.0 22.0 72.5 58.3 35.3 6.5 0.0 0.0 2.5 29.0 62.0 6.5 0.0 NA NA NA NA NA NA NA NA NA NA
MAL-W23-005
Rapid 1-2-3 HEMA® CASSETTE MALARIA MAL-PF/Pan-
Hema Diagnostic Systems 4.5 11.5 31.0 29.3 23.8 0.0 0.0 5.5 19.0 75.5 61.8 36.3 2.0 0.0 0.0 2.5 20.0 70.0 7.5 0.0 NA NA NA NA NA NA NA NA NA NA
PF/PAN CAS/25
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria
ITP11003-TC25 InTec Products, Inc. 3.3 16.0 35.3 31.5 14.0 1.0 0.5 4.5 25.0 69.0 NA NA NA NA NA NA NA NA NA NA 99.0 1.0 0.0 0.0 0.0 99.0 0.5 0.0 0.0 0.5
(p.f/p.v.) Tri-line Test
12.3 56.1 31.6 0.0 0.0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 2.0 2.0 33.0 53.0 10.0 NA NA NA NA NA NA NA NA NA NA 99.0 1.0 0.0 0.0 0.0 99.0 1.0 0.0 0.0 0.0
(399) (399) (399) (399) (399)
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 9.8 22.0 35.0 25.8 7.5 0.5 1.0 13.5 21.0 64.0 NA NA NA NA NA NA NA NA NA NA 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH)
RMVM-03091 Access Bio Ethiopia 3.3 18.5 24.8 27.0 26.5 0.0 0.5 3.0 15.0 81.5 NA NA NA NA NA NA NA NA NA NA 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0
Ag Combo RDT
CareStart™ Malaria Pf/Pv (HRP2/pLDH)
RMVM-05072 Access Bio, Inc. 5.5 19.0 29.5 25.0 21.0 0.5 0.0 8.0 17.5 74.0 NA NA NA NA NA NA NA NA NA NA 98.3 1.8 0.0 0.0 0.0 98.0 2.0 0.0 0.0 0.0
Ag. Combo RDT
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 3.3 15.5 23.0 27.3 31.0 0.0 0.5 2.5 12.5 84.5 NA NA NA NA NA NA NA NA NA NA 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0
GCMAL(pf/pv)-
Zhejiang Orient Gene
Malaria Pf/Pv Rapid Test 5.8 15.0 37.0 26.8 15.5 1.0 0.0 10.5 20.5 68.0 NA NA NA NA NA NA NA NA NA NA 100.0 0.0 0.0 0.0 0.0 99.5 0.0 0.0 0.5 0.0
402a Biotech Co., Ltd.
Medical Diagnostech 9.8 12.0 29.6 29.8 18.8
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 0.5 0.5 6.5 18.0 74.5 NA NA NA NA NA NA NA NA NA NA 77.8 20.3 2.0 0.0 0.0 7.5 29.0 59.5 4.0 0.0
(Pty) Ltd (399) (399) (399) (399) (399)
Guangzhou Wondfo
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C 4.5 23.3 34.5 27.3 10.5 0.0 2.0 6.0 29.0 63.0 NA NA NA NA NA NA NA NA NA NA 99.8 0.2 0.0 0.0 0.0 99.0 1.0 0.0 0.0 0.0
Biotech Co., Ltd.
One Step Test for Malaria Pf/Pv Ag
MFLRPD-02 Meril Diagnostics Pvt. Ltd. 15.5 24.0 34.3 23.5 2.8 0.0 1.5 21.0 31.5 46.0 NA NA NA NA NA NA NA NA NA NA 99.5 0.5 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0
MERISCREEN Malaria Pf/Pv Ag
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 11.3 25.0 33.5 27.3 3.0 0.5 2.0 12.5 36.0 49.0 NA NA NA NA NA NA NA NA NA NA 60.3 36.3 3.5 0.0 0.0 72.5 24.5 3.0 0.0 0.0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Alere Medical Private
11108191040 9.5 13.3 31.5 37.8 8.0 1.0 0.5 8.0 29.5 61.0 NA NA NA NA NA NA NA NA NA NA 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0
Trueline Malaria Ag Pf/Pv Limited
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 5.8 12.0 27.3 31.5 23.5 0.5 1.0 3.0 21.0 74.5 14.0 53.3 32.0 0.8 0.0 0.0 3.5 36.0 47.0 13.5 99.3 0.8 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0
NA, not applicable
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species
a Denotes no visible band
b 3 (3%) of the 100 P. falciparum high parasite density dilution samples were at 5000 parasites/μl rather than 2000
c Calculations include invalid tests

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

115
 11 6
Table A4.3: Distribution of test band intensity scores (0-4) for phase-2 wild-type P. vivax samples at low (200) and high (2000) parasite density (parasites/µl)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl

Product Percentage distribution Percentage distribution Percentage distribution of Percentage distribution of Percentage distribution Percentage distribution
Product code Manufacturer of Pf test band intensityb of Pf test band intensityb pan test band intensityb pan test band intensityb of Pv test band intensityb of Pv test band intensityb
(n=140) (n=70) (n=140) (n=70) (n=140) (n=70)
0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Advy Chemical Private
RKMAL017 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Antigen Detection Test Limited
ADVANCED QUALITY™ ONE STEP Malaria
ITP11002-TC25 InTec Products, Inc. 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
(p.f) Test
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 99.3 0.7 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf (HRP2/pLDH) Ag
Combo 3-Line - HRP2 band 99.3 0.7 0.0 0.0 0.0 98.6 1.4 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf (HRP2/pLDH) Ag RMSM-05071 Access Bio, Inc.
98.6 0.0 0.0 1.4 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Combo 3-Line - Pf-pLDH band
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 95.0 5.0 0.0 0.0 0.0 98.6 1.4 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Shanghai Kehua Bio-
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
engineering Co., Ltd.
G C M A L ( p f ) - Zhejiang Orient Gene
Malaria Pf Rapid Test 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
402a Biotech Co., Ltd.
Medical Diagnostech
GMD Malaria Pf test GMDMALPF001 97.1 2.9 0.0 0.0 0.0 98.6 1.4 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
(Pty) Ltd
Guangzhou Wondfo
One Step Malaria HRP2 (P.f) Test W37-C 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Biotech Co., Ltd.
One Step Test for Malaria Pf HRP-II
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 99.3 0.7 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Ag MERISCREEN Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
SD BIOLINE Malaria Ag P.f. (HRP2/
05FK130-40-0 Standard Diagnostics, Inc. 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA
pLDH) 2 Lines
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Advy Chemical Private
RKMAL016 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 27.1 66.4 6.4 0.0 0.0 0.0 1.4 52.9 42.9 2.9 NA NA NA NA NA NA NA NA NA NA
Detection Kit Limited
Alere Trueline™ – Rapid test kit for Alere Medical Private
05FK60AI-40 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 2.1 39.3 55.7 2.9 0.0 0.0 0.0 11.4 71.4 17.1 NA NA NA NA NA NA NA NA NA NA
Malaria Ag Pf/Pan (HRP-II/pLDH) Limited
AllTest™ Malaria P.f./Pan Rapid Test Hangzhou AllTest Biotech
IMPN-402 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 15.0 70.7 14.3 0.0 0.0 0.0 0.0 31.4 61.4 7.1 NA NA NA NA NA NA NA NA NA NA
Cassette Co. Ltd.
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 0.0 30.0 65.7 4.3 0.0 0.0 0.0 1.4 58.6 40.0 NA NA NA NA NA NA NA NA NA NA
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 98.6 0.0 0.7 0.7 0.0 100.0 0.0 0.0 0.0 0.0 2.9 17.9 75.0 4.3 0.0 0.0 0.0 4.3 60.0 35.7 NA NA NA NA NA NA NA NA NA NA
BIOCREDIT Malaria Ag Pf/Pan (HRPII/
C32RHA25 RapiGEN Inc. 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 0.0 39.3 58.6 2.1 0.0 0.0 0.0 4.3 54.3 41.4 NA NA NA NA NA NA NA NA NA NA
pLDH)
 Table A4.3 (continued)
200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl 200 parasites/µl 2000 parasites/µl

Product Percentage distribution Percentage distribution Percentage distribution of Percentage distribution of Percentage distribution Percentage distribution
Product code Manufacturer of Pf test band intensityb of Pf test band intensityb pan test band intensityb pan test band intensityb of Pv test band intensityb of Pv test band intensityb
(n=140) (n=70) (n=140) (n=70) (n=140) (n=70)
0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4 0a 1 2 3 4
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 5.0 67.1 27.1 0.7 0.0 0.0 0.0 28.6 60.0 11.4 NA NA NA NA NA NA NA NA NA NA
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 99.3 0.0 0.7 0.0 0.0 97.1 1.4 1.4 0.0 0.0 0.0 10.7 73.6 15.0 0.7 0.0 0.0 1.4 30.0 68.6 NA NA NA NA NA NA NA NA NA NA
CareStart™ Malaria Pf/PAN (pLDH)
RMLM-05071 Access Bio, Inc. 99.3 0.7 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 96.4 3.6 0.0 0.0 0.0 21.4 50.0 25.7 2.9 0.0 NA NA NA NA NA NA NA NA NA NA
Ag RDT
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 1.4 0.7 61.4 33.6 2.9 1.4 0.0 0.0 5.7 92.9 NA NA NA NA NA NA NA NA NA NA
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 44.3 46.4 8.6 0.7 0.0 0.0 4.3 61.4 32.9 1.4 NA NA NA NA NA NA NA NA NA NA
Medsource Ozone
Is It... Malaria Pf PAN MPFPAN050 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 0.0 11.4 79.3 7.1 2.1 0.0 0.0 4.3 32.9 62.9 NA NA NA NA NA NA NA NA NA NA
Biomedicals Pvt. Ltd.
NGB-
NG-Test MALARIA Pf/Pan (pLDH) NG Biotech 96.4 3.6 0.0 0.0 0.0 95.7 4.3 0.0 0.0 0.0 31.4 53.6 15.0 0.0 0.0 0.0 11.4 65.7 22.9 0.0 NA NA NA NA NA NA NA NA NA NA
MAL-W23-005
Rapid 1-2-3 HEMA® CASSETTE MALARIA MAL-PF/Pan-
Hema Diagnostic Systems 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 0.0 39.3 58.6 2.1 0.0 0.0 0.0 14.3 64.3 21.4 NA NA NA NA NA NA NA NA NA NA
PF/PAN CAS/25
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria
ITP11003-TC25 InTec Products, Inc. 100.0 0.0 0.0 0.0 0.0 98.6 1.4 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 0.7 12.9 77.9 8.6 0.0 1.4 0.0 2.9 40.0 55.7
(p.f/p.v.) Tri-line Test
BIOCREDIT Malaria Ag Pf/Pv (pLDH/
C60RHA25 RapiGEN Inc. 100.0 0.0 0.0 0.0 0.0 98.6 1.4 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 0.7 0.0 49.3 48.6 1.4 2.9 0.0 0.0 1.4 95.7
pLDH)
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 2.9 47.1 49.3 0.7 0.0 1.4 0.0 14.3 71.4 12.9
CareStart™ Malaria Pf/Pv (HRP2/pLDH)
RMVM-03091 Access Bio Ethiopia 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 0.7 32.9 60.7 5.7 0.0 0.0 0.0 7.1 40.0 52.9
Ag Combo RDT
CareStart™ Malaria Pf/Pv (HRP2/pLDH)
RMVM-05072 Access Bio, Inc. 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 0.0 2.1 65.7 28.6 3.6 0.0 0.0 0.0 5.7 94.3
Ag. Combo RDT
careUS™ Malaria Combo Pf/Pv (HRP2/
RMV-M05082 WELLS BIO, INC 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 2.9 32.1 60.0 4.3 0.7 0.0 0.0 8.6 32.9 58.6
pLDH) Ag
GCMAL(pf/pv)- Zhejiang Orient Gene
Malaria Pf/Pv Rapid Test 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 15.0 65.0 20.0 0.0 0.0 0.0 0.0 38.6 51.4 10.0
402a Biotech Co., Ltd.
Medical Diagnostech
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 95.7 4.3 0.0 0.0 0.0 92.9 7.1 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 79.3 18.6 2.1 0.0 0.0 82.9 15.7 0.0 1.4 0.0
(Pty) Ltd
One Step Malaria HRP2/pLDH (P.f/P.v) Guangzhou Wondfo
W056-C 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 15.7 70.0 14.3 0.0 0.0 0.0 0.0 44.3 45.7 10.0
Test Biotech Co., Ltd.
One Step Test for Malaria Pf/Pv Ag
MFLRPD-02 Meril Diagnostics Pvt. Ltd. 99.3 0.7 0.0 0.0 0.0 98.6 0.0 1.4 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 5.7 51.4 40.0 2.9 0.0 0.0 0.0 8.6 71.4 20.0
MERISCREEN Malaria Pf/Pv Ag
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 3.6 67.9 28.6 0.0 0.0 0.0 0.0 45.7 48.6 5.7
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Alere Medical Private
11108191040 100.0 0.0 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 NA NA NA NA NA NA NA NA NA NA 5.0 42.9 48.6 3.6 0.0 0.0 0.0 11.4 71.4 17.1
Trueline Malaria Ag Pf/Pv Limited
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 99.3 0.7 0.0 0.0 0.0 100.0 0.0 0.0 0.0 0.0 0.0 18.6 70.7 10.0 0.7 0.0 0.0 0.0 32.9 67.1 9.3 49.3 39.3 2.1 0.0 0.0 0.0 21.4 38.6 40.0
NA, not applicable
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species 
a Denotes no visible band
b Calculations include invalid tests

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

117
 11 8
Table A4.4: Phase 2 P. falciparum test line false-positive rates for wild-type P. vivax samples at low (200) and high (2000) parasite density (parasites/µl)
P. vivax samples (n=35)
200 parasites/µl 2000 parasites/µl
Product Product code Manufacturer
False positive Pf infectiona (%) False positive Pf infectiona (%)
Lot 1 (n=70) Lot 2 (n=70) Overall (n=140) Lot 1 (n=35) Lot 2 (n=35) Overall (n=70)
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 0.0 0.0 0.0 0.0 0.0 0.0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 0.0 0.0 0.0 0.0 0.0 0.0
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 0.0 1.4 0.7 0.0 0.0 0.0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - HRP2 band 1.4 0.0 0.7 2.9 0.0 1.4
RMSM-05071 Access Bio, Inc.
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - Pf-pLDH band 0.0 2.9 1.4 0.0 0.0 0.0
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 0.0 0.0 0.0 0.0 0.0 0.0
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 0.0 0.0 0.0 0.0 0.0 0.0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 5.7 4.3 5.0 2.9 0.0 1.4
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 (69) 0.0 (139) 0.0 0.0 0.0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 2.9 2.9 2.9 2.9 0.0 1.4
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0
One Step Test for Malaria Pf HRP-II Ag
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 0.0 1.4 0.7 0.0 0.0 0.0
MERISCREEN Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 0.0 0.0 0.0 0.0 0.0 0.0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 0.0 0.0 0.0 0.0 0.0 0.0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 0.0 0.0 0.0 0.0 0.0 0.0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 0.0 0.0 0.0 0.0 0.0 0.0
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0.0 0.0 0.0 0.0 0.0 0.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 2.9 (69) 0 (69) 1.4 (138) 0.0 0.0 0.0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0.0 0.0 0.0 0.0 0.0 0.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0.0 0.0 0.0 0.0 0.0 0.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 1.4 0.0 0.7 2.9 2.9 2.9
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0.0 1.4 0.7 0.0 0.0 0.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0.0 0.0 0.0 0.0 0.0 0.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 0.0 0.0 0.0 0.0 0.0 0.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 4.3 (69) 2.9 3.6 (139) 5.7 2.9 4.3
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 0.0 0.0 0.0 0.0 0.0 0.0
 Table A4.4 (continued)
P. vivax samples (n=35)
200 parasites/µl 2000 parasites/µl
Product Product code Manufacturer
False positive Pf infectiona (%) False positive Pf infectiona (%)
Lot 1 (n=70) Lot 2 (n=70) Overall (n=140) Lot 1 (n=35) Lot 2 (n=35) Overall (n=70)
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0.0 0.0 0.0 0.0 2.9 (34) 1.4 (69)
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0.0 (69) 0.0 0.0 (139) 0.0 3.0 (33) 1.5 (68)
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0.0 0.0 0.0 0.0 0.0 (34) 0.0 (69)
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0.0 0.0 0.0 0.0 0.0 0.0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0.0 0.0 0.0 0.0 0.0 0.0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 7.1 1.4 4.3 8.6 5.7 7.1
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 1.4 0.0 0.7 2.9 0.0 1.4
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 0.0 0.0 0.0 0.0 0.0 0.0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0.0 1.4 0.7 0.0 0.0 0.0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species
a Pf positive line indicates a false-positive P. falciparum infection

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

119
 12 0
Table A4.5: Phase 2 pan (or P. vivax) test line false-positive rate for non-P. falciparum infection on phase 2 wild-type P. falciparum samples at low (200) and high (2000) parasite density (parasites/µl)
P. falciparum samples (n=100)
200 parasites/µl 2000a parasites/µl
Product Product code Manufacturer
False positive non-Pf infection (%) False positive non-Pf infection (%)
Lot 1 (n=200) Lot 2 (n=200) Overall (n=400) Lot 1 (n=100) Lot 2 (n=100) Overall (n=200)
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 2.5 0.0 1.3 1.0 1.0 1.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 1.0 1.5 1.3 2.0 2.0 2.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0.5 0.5 (199) 0.5 (399) 1.0 1.0 1.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 0.0 (199) 0.5 0.3 (399) 2.0 0.0 1.0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0.0 0.0 0.0 0.0 1.0 0.5
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0.0 0.0 0.0 0.0 0.0 0.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 1.0 0.5 0.8 1.0 0.0 0.5
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 1.0 1.5 1.3 1.0 0.0 0.5
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 0.0 0.5 0.3 1.0 1.0 1.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 1.0 3.0 2.0 1.0 0.0 0.5
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 0.5 1.0 (199) 0.8 (399) 1.0 1.0 1.0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 0.0 0.0 0.0 0.0 0.0 0.0
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 1.5 0.5 1.0 1.0 1.0 1.0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 1.0 (199) 1.0 1.0 (399) 1.0 (99) 1.0 1.0 (199)
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 1.5 2.0 1.8 2.0 2.0 2.0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0.0 0.0 0.0 0.0 0.0 0.0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 0.0 0.0 (99) 1.0 0.5 (199)
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 21.5 23.0 22.3 92.0 93.0 92.5
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0.5 0.0 0.3 1.0 1.0 1.0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 1.0 0.0 0.5 0.0 0.0 0.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 45.0 34.5 39.8 24.0 31.0 27.5
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0
Pf, Pv and Pan
PALUTOP +4 optima® - Pv-pLDH band 0.0 1.0 0.5 0.0 0.0 0.0
5499 ALLDIAG SA
PALUTOP +4 optima® - Pan-pLDH band 1.0 0.5 0.8 1.0 0.0 0.5
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species 
a 3 (3%) of the 100 P. falciparum high parasite density dilution samples were at 5000 parasites/μl rather than 2000
 Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 121
 12 2
Table A4.6: Phase-2 false-positive rate for P. falciparum test line results on all malaria-negative samples

Percentage of false positive Pf test lines Percentage of false positive Pf test lines Percentage of false positive Pf test lines
on cleana negative samples on samples containing on samples containing
Product Product code Manufacturer non-Plasmodium spp. infectious agentsb immunological factorsc
Lot 1 Lot 2 Overall Lot 1 Lot 2 Overall Lot 1 Lot 2 Overall
(n=116) (n=116) (n=232) (n=30) (n=30) (n=60) (n=54) (n=54) (n=108)
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 3.7 5.6 4.6
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 0.9 0.0 0.4 0.0 0.0 0.0 0.0 1.9 0.9
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 1.7 (115) 0.0 0.9 (231) 0.0 0.0 0.0 0.0 0.0 0.0
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 2.6 0.0 1.3 0.0 0.0 0.0 14.8 14.8 14.8
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 0.0 0.9 0.4 0.0 0.0 0.0 3.7 5.6 4.6
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line
- HRP2 band 0.9 0.0 0.4 0.0 0.0 0.0 3.7 3.7 3.7
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line RMSM-05071 Access Bio, Inc.
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
- Pf-pLDH band
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 1.7 0.0 0.9 0.0 3.3 1.7 3.7 3.7 3.7
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 0.0 0.0 0.0 0.0 0.0 0.0 1.9 1.9 1.9
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 1.7 1.7 1.7 6.7 0.0 3.3 11.1 9.3 10.2
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 0.9 0.0 (115) 0.4 (231) 3.3 3.3 3.3 3.7 5.6 4.6
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 7.4 7.4 7.4
One Step Test for Malaria Pf HRP-II Ag MERISCREEN
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 0.0 0.0 0.0 0.0 3.3 1.7 0.0 1.9 0.9
Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 0.0 0.0 0.0 0.0 0.0 0.0 11.1 18.5 14.8
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 0.0 0.0 0.0 0.0 0.0 0.0 14.8 14.8 14.8
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 0.0 (115) 0.0 0.0 (231) 0.0 0.0 0.0 5.6 3.7 4.6
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0.0 0.0 0.0 3.3 0.0 1.7 0.0 0.0 0.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan
05FK60AI-40 Alere Medical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 3.7 0.0 1.9

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
(HRP-II/pLDH)
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0.9 0.0 0.4 0.0 0.0 0.0 0.0 0.0 0.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0.9 1.7 1.3 3.3 0.0 1.7 1.9 3.7 2.8
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 1.7 (115) 0.9 1.3 (231) 0.0 0.0 0.0 3.7 3.7 3.7
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0.0 0.0 0.0 3.3 0.0 1.7 0.0 1.9 0.9
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0.0 0.0 0.0 0.0 3.3 1.7 1.9 3.7 2.8
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 0.9 0.9 0.9 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0.0 0.9 0.4 0.0 0.0 0.0 3.7 5.6 4.6
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0.0 (115) 0.0 0.0 (231) 0.0 0.0 0.0 3.7 5.6 4.6
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 1.7 0.0 0.9 0.0 3.3 1.7 5.6 5.6 5.6
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
 Table A4.6 (continued)

Percentage of false positive Pf test lines Percentage of false positive Pf test lines Percentage of false positive Pf test lines
on cleana negative samples on samples containing on samples containing
Product Product code Manufacturer non-Plasmodium spp. infectious agentsb immunological factorsc
Lot 1 Lot 2 Overall Lot 1 Lot 2 Overall Lot 1 Lot 2 Overall
(n=116) (n=116) (n=232) (n=30) (n=30) (n=60) (n=54) (n=54) (n=108)
NGB-
NG-Test MALARIA Pf/Pan (pLDH) NG Biotech 6.0 1.7 3.9 10.0 13.3 11.7 22.2 24.1 23.1
MAL-W23-005
MAL-PF/Pan-
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN Hema Diagnostic Systems 0.0 0.9 0.4 0.0 0.0 0.0 1.9 3.7 2.8
CAS/25
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-
ITP11003-TC25 InTec Products, Inc. 0.0 0.0 0.0 0.0 0.0 0.0 1.9 3.7 2.8
line Test
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0.0 (114) 0.0 0.0 (230) 3.3 0.0 1.7 0.0 0.0 0.0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0.0 (115) 0.0 (114) 0.0 (229) 3.3 0.0 1.7 1.9 5.6 3.7
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0.0 0.0 0.0 0.0 0.0 0.0 3.7 1.9 2.8
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0.0 0.0 (115) 0.0 (231) 0.0 0.0 0.0 1.9 1.9 1.9
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0.0 0.0 0.0 0.0 6.7 3.3 1.9 3.7 2.8
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 (115) 0.0 (231) 0.0 (28) 0.0 0.0 (58) 1.9 0.0 0.9
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 6.0 4.3 5.2 6.7 0.0 3.3 13.0 11.1 12.0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria
MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0.0 0.0 0.0 0.0 3.3 1.7 1.9 0.0 0.9
Pf/Pv Ag
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 0.0 0.9 (115) 0.4 (231) 0.0 0.0 0.0 3.7 3.7 3.7
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria
11108191040 Alere Medical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 3.7 0.0 1.9
Ag Pf/Pv
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium spp. 
a Blood samples from healthy volunteers with no known current illness or blood abnormality
b See Table A4.7 for details
c See Table A4.8 for details

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

123
 12 4
Table A4.7: Phase 2 false-positive rate for P. falciparum in samples containing specific non-malarial infectious pathogens
Percentage of false positives for Plasmodium spp. by infectious pathogen
Product Product code Manufacturer Chagas Dengue Leishmaniasis Schistosomiasis
Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=14) Lot 2 (n=14) Lot 1 (n=8) Lot 2 (n=8) Lot 1 (n=4) Lot 2 (n=4)
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - HRP2 band 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
RMSM-05071 Access Bio, Inc.
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - Pf-pLDH band 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 0.0 0.0 0.0 0.0 0.0 12.5 0.0 0.0
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 25.0 0.0 7.1 0.0 0.0 0.0 0.0 0.0
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 25.0 25.0 0.0 0.0 0.0 0.0 0.0 0.0
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
One Step Test for Malaria Pf HRP-II Ag
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 25.0
MERISCREEN Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0.0 0.0 7.1 0.0 0.0 0.0 0.0 0.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan
05FK60AI-40 Alere Medical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
(HRP-II/pLDH)
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 25.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 25.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0.0 0.0 0.0 7.1 0.0 0.0 0.0 0.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 0.0 25.0 0.0 0.0 0.0 0.0 0.0 0.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 25.0 25.0 7.1 21.4 12.5 0.0 0.0 0.0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
 Table A4.7 (continued)
Percentage of false positives for Plasmodium spp. by infectious pathogen
Product Product code Manufacturer Chagas Dengue Leishmaniasis Schistosomiasis
Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=14) Lot 2 (n=14) Lot 1 (n=8) Lot 2 (n=8) Lot 1 (n=4) Lot 2 (n=4)
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 25.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0.0 0.0 7.1 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0.0 0.0 0.0 0.0 0.0 25.0 0.0 0.0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0.0 (3) 0.0 0.0 (13) 0.0 0.0 0.0 0.0 0.0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 25.0 0.0 7.1 0.0 0.0 0.0 0.0 0.0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 12.5 0.0 0.0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species 

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

125
 12 6
Table A4.8: Phase 2 false-positive rate for P. falciparum in samples containing potentially cross-reacting blood immunological factors
Percentage of false positives for Plasmodium spp. by blood immunological factor

Product Product code Manufacturer Anti-mouse antibodies Anti-nuclear antibodies Rheumatoid factor Rapid plasma reagin (RPR)
positive
Lot 1 (n=6) Lot 2 (n=6) Lot 1 (n=24) Lot 2 (n=24) Lot 1 (n=12) Lot 2 (n=12) Lot 1 (n=12) Lot 2 (n=12)
Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 33.3 33.3 0.0 4.2 0.0 0.0 0.0 0.0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 0.0 16.7 0.0 0.0 0.0 0.0 0.0 0.0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 66.7 66.7 0.0 0.0 33.3 33.3 0.0 0.0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 33.3 33.3 0.0 4.2 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - HRP2 band 33.3 33.3 0.0 0.0 0.0 0.0 0.0 0.0
RMSM-05071 Access Bio, Inc.
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - Pf-pLDH band 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 33.3 33.3 0.0 0.0 0.0 0.0 0.0 0.0
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 16.7 16.7 0.0 0.0 0.0 0.0 0.0 0.0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 50.0 50.0 8.3 0.0 8.3 0.0 0.0 16.7
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 33.3 33.3 0.0 4.2 0.0 0.0 0.0 0.0
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 33.3 33.3 0.0 0.0 16.7 16.7 0.0 0.0
One Step Test for Malaria Pf HRP-II Ag
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 0.0 16.7 0.0 0.0 0.0 0.0 0.0 0.0
MERISCREEN Malaria Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 16.7 66.7 0.0 0.0 41.7 50.0 0.0 0.0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 33.3 33.3 0.0 0.0 50.0 50.0 0.0 0.0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 50.0 33.3 0.0 0.0 0.0 0.0 0.0 0.0
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 33.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0.0 16.7 4.2 0.0 0.0 8.3 0.0 0.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 0.0 33.3 0.0 0.0 16.7 0.0 0.0 0.0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0.0 0.0 0.0 0.0 0.0 8.3 0.0 0.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 16.7 33.3 0.0 0.0 0.0 0.0 0.0 0.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0.0 0.0 0.0 0.0 16.7 25.0 0.0 0.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0.0 33.3 0.0 0.0 16.7 8.3 0.0 0.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 50.0 33.3 0.0 4.2 0.0 0.0 0.0 0.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 33.3 16.7 33.3 25.0 8.3 25.0 8.3 25.0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 16.7 33.3 0.0 0.0 0.0 0.0 0.0 0.0
 Table A4.8 (continued)
Percentage of false positives for Plasmodium spp. by blood immunological factor

Product Product code Manufacturer Anti-mouse antibodies Anti-nuclear antibodies Rheumatoid factor Rapid plasma reagin (RPR)
positive
Lot 1 (n=6) Lot 2 (n=6) Lot 1 (n=24) Lot 2 (n=24) Lot 1 (n=12) Lot 2 (n=12) Lot 1 (n=12) Lot 2 (n=12)
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0.0 33.3 0.0 0.0 0.0 0.0 8.3 0.0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 16.7 33.3 0.0 4.2 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 33.3 16.7 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 16.7 16.7 0.0 0.0 0.0 0.0 0.0 0.0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 16.7 33.3 0.0 0.0 0.0 0.0 0.0 0.0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 16.7 0.0 0.0 0.0 0.0 0.0 0.0 0.0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 16.7 0.0 12.5 16.7 25.0 0.0 0.0 16.7
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0.0 0.0 4.2 0.0 0.0 0.0 0.0 0.0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 33.3 33.3 0.0 0.0 0.0 0.0 0.0 0.0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 33.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species 

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

127
 12 8
Table A4.9: Phase 2 false-positive rate of pan or P. vivax test line results on all malaria-negative samples

Percentage of false positive pan test Percentage of false positive non-Pf Percentage of false positive non-Pf
lines on "clean"a negative samples test lines on samples containing non- test lines on samples containing
Product Product code Manufacturer Plasmodium spp. infectious agentsb immunological factorsc
Lot 1 Lot 2 Overall Lot 1 Lot 2 Overall Lot 1 Lot 2 Overall
(n=116) (n=116) (n=232) (n=30) (n=30) (n=60) (n=54) (n=54) (n=108)
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan
05FK60AI-40 Alere Medical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
(HRP-II/pLDH)
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0.0 0.9 0.4 0.0 0.0 0.0 0.0 1.9 0.9
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0.0 0.0 0.0 0.0 0.0 0.0 0.0 1.9 0.9
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 0.0 (115) 0.9 0.4 (231) 0.0 0.0 0.0 5.6 1.9 3.7
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 4.3 3.4 3.9 0.0 0.0 0.0 0.0 1.9 0.9
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0.0 0.0 0.0 0.0 0.0 0.0 3.7 3.7 3.7
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 1.7 0.9 1.3 3.3 0.0 1.7 13.0 14.8 13.9
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0.0 (115) 0.0 0.0 (231) 0.0 0.0 0.0 5.6 9.3 7.4
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 0.9 0.0 0.4 3.3 3.3 3.3 20.4 18.5 19.4
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 3.4 4.3 3.9 16.7 3.3 10.0 5.6 9.3 7.4
NGB-
NG-Test MALARIA Pf/Pan (pLDH) NG Biotech 37.9 27.6 32.8 46.7 46.7 46.7 68.5 81.5 75.0
MAL-W23-005
MAL-PF/Pan-
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN Hema Diagnostic Systems 0.0 0.0 0.0 0.0 0.0 0.0 7.4 7.4 7.4
CAS/25
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0.9 0.0 0.4 0.0 0.0 0.0 16.7 14.8 15.7
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0.0 (114) 0.0 0.0 (230) 0.0 0.0 0.0 0.0 0.0 0.0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0.0 (115) 0.0 (114) 0.0 (229) 0.0 0.0 0.0 3.7 3.7 3.7
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0.0 0.0 0.0 0.0 0.0 0.0 5.6 3.7 4.6
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0.0 0.0 (115) 0.0 (231) 0.0 0.0 0.0 11.1 11.1 11.1
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0.0 0.0 0.0 0.0 0.0 0.0 1.9 0.0 0.9
GCMAL(pf/pv)-
Malaria Pf/Pv Rapid Test Zhejiang Orient Gene Biotech Co., Ltd. 0.0 0.0 (115) 0.0 (231) 0.0 (28) 0.0 0.0 (58) 1.9 1.9 1.9
402a
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 19.0 21.6 20.3 20.0 16.7 18.3 37.0 46.3 41.7
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 1.7 0.9 1.3 0.0 0.0 0.0 0.0 0.0 0.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 23.3 22.6 (115) 22.9 (231) 53.3 36.7 45.0 64.8 61.1 63.0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Pf, Pv and Pan
PALUTOP +4 optima® - Pv-pLDH band 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0
5499 ALLDIAG SA
PALUTOP +4 optima® - Pan-pLDH band 0.0 0.0 0.0 0.0 0.0 0.0 3.7 3.7 3.7
NA, not applicable
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species 
a Blood samples from healthy volunteers with no known current illness or blood abnormality
b See Table A4.7 for details
c See Table A4.8 for details
 Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 129
 13 0
Table A4.10: Heat stability testing results for P. falciparum test line on a P. falciparum sample at low parasite density (200 parasites/µl). Positivity rate at baseline (room temperature)
and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity

Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band

Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 15 0 3.0 15 0 3.0 15 0 2.9 15 0 2.1 15 0 3.0 15 0 2.5 15 0 2.9 15 0 3.0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 2.9 15 0 3.1 15 0 3.0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 15 0 3.9 15 0 4.0 15 0 3.7 15 0 3.6 15 0 3.4 15 0 3.6 15 0 3.9 15 0 3.7
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 15 0 3.0 15 0 3.0 15 0 2.9 15 0 3.0 15 0 3.0 15 0 3.0 15 0 2.9 15 0 3.0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 15 0 3.1 15 0 3.3 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.1
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 15 0 3.9 15 0 3.5 15 0 3.9 15 0 3.6 15 0 3.4 15 0 3.4 15 0 3.9 15 0 3.5
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - HRP2 band 15 0 2.9 15 0 3.6 15 0 3.0 15 0 3.0 15 0 3.1 15 0 3.0 15 0 4.0 15 0 3.1
RMSM-05071 Access Bio, Inc.
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - Pf-pLDH band 15 0 1.8 15 0 1.0 15 0 1.2 15 0 1.1 15 0 1.4 15 0 1.1 15 0 1.8 15 0 1.1
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 15 0 3.8 15 0 3.4 15 0 4.0 15 0 3.5 15 0 3.6 15 0 3.1 15 0 3.9 15 0 3.4
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 15 0 2.8 15 0 3.0 15 0 2.0 15 0 2.0 15 0 1.6 15 0 2.0 15 0 3.0 15 0 3.0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 15 0 3.3 15 0 3.9 15 0 3.5 15 0 3.0 15 0 3.5 15 0 3.1 15 0 3.9 15 0 2.9
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 15 0 3.0 15 0 3.0 15 0 2.9 15 0 2.9 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 15 0 3.0 15 0 3.3 15 0 3.0 15 0 3.0 15 0 3.0 14 1 2.9 15 0 3.2 15 0 3.0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 15 0 2.8 15 0 3.4 15 0 3.4 15 0 2.9 15 0 2.8 15 0 3.0 15 0 3.4 15 0 3.0
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 15 0 3.0 15 0 3.0 15 0 2.9 15 0 2.9 15 0 3.0 15 0 3.0 15 0 3.2 15 0 2.9
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 15 0 2.3 15 0 2.9 15 0 2.2 15 0 2.0 15 0 2.0 15 0 2.0 15 0 2.4 15 0 2.4
Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 15 0 3.0 15 0 3.0 15 0 3.6 15 0 3.0 15 0 3.8 15 0 3.1 15 0 4.0 15 0 3.0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 15 0 1.5 15 0 2.0 15 0 1.9 15 0 2.0 14 1 2.3 15 0 2.0 15 0 2.5 15 0 2.0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 15 0 2.0 15 0 2.4 15 0 2.0 15 0 2.0 15 0 2.2 15 0 2.0 15 0 2.1 15 0 2.0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 15 0 2.8 15 0 3.0 15 0 3.0 15 0 2.7 15 0 2.9 15 0 3.0 15 0 2.9 15 0 2.9
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 15 0 2.0 15 0 2.4 15 0 2.0 15 0 1.9 15 0 2.0 15 0 1.9 14 0 2.1 15 0 1.9
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 15 0 2.9 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 15 0 2.0 15 0 2.0 15 0 2.0 15 0 2.1 15 0 2.3 15 0 2.0 15 0 2.0 15 0 2.1
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 15 0 2.9 15 0 2.9 15 0 2.9 15 0 2.9 15 0 2.7 15 0 2.9 15 0 3.1 15 0 3.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 15 0 2.8 15 0 3.0 15 0 2.7 15 0 3.0 15 0 3.0 15 0 2.9 15 0 2.7 15 0 3.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 15 0 3.0 15 0 3.0 15 0 3.1 15 0 3.0 15 0 3.3 15 0 3.1 15 0 3.3 15 0 3.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 15 0 3.0 15 0 2.9 15 0 2.9 15 0 2.0 15 0 2.0 14 0 2.0 15 0 3.0 15 0 3.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 15 0 3.0 15 0 3.4 15 0 3.0 15 0 3.0 15 0 2.9 15 0 3.0 15 0 3.0 15 0 3.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 15 0 1.4 15 0 1.5 15 0 1.3 14 0 1.4 15 0 1.3 13 0 1.4 15 0 1.4 15 0 1.6
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 15 0 3.0 15 0 3.6 15 0 3.1 15 0 3.0 15 0 3.1 15 0 3.0 15 0 3.9 15 0 3.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 2.9
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 15 0 2.9 15 0 2.9 15 0 3.0 13 0 3.0 15 0 3.0 15 0 3.0 15 0 3.7 15 0 2.9
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 15 0 3.1 15 0 3.1 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.3 15 0 3.0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 15 0 3.5 15 0 3.7 15 0 3.0 15 0 3.0 15 0 3.1 15 0 3.0 15 0 3.5 15 0 3.0
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 15 0 2.9 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 13 0 1.0 15 0 1.0 15 0 1.0 11 0 1.0 4 1 1.0 13 0 1.0 15 0 1.0 15 0 1.0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 15 0 3.0 15 0 3.0 15 0 3.0 15 0 2.0 15 0 2.0 15 0 1.8 15 0 3.0 15 0 3.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 15 0 3.0 15 0 3.0 15 0 3.7 15 0 3.0 15 0 2.9 15 0 3.0 15 0 3.6 15 0 2.9
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 15 0 2.6 15 0 3.1 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.7 15 0 2.9
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 15 0 3.0 15 0 3.1 15 0 3.9 15 0 2.9 15 0 3.0 15 0 3.0 15 0 3.7 15 0 3.0
 Table A4.10 (continued)
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity

Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band

Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 15 0 3.1 15 0 3.1 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.1 15 0 3.0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 15 0 3.1 15 0 3.9 15 0 3.4 15 0 3.0 15 0 3.1 15 0 3.0 15 0 3.6 15 0 3.1
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 15 0 3.0 15 0 3.0 15 0 3.0 15 0 2.9 15 0 3.0 15 0 3.0 15 0 3.4 15 0 2.9
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 15 0 2.7 15 0 3.0 15 0 2.7 15 0 2.1 15 0 2.1 15 0 2.0 15 0 2.7 15 0 2.9
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 15 0 2.9 15 0 2.9 15 0 3.0 15 0 2.0 15 0 2.9 15 0 2.9 15 0 2.7 15 0 3.0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 15 0 3.0 15 0 2.9 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.0 15 0 3.2 15 0 3.0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 15 0 3.0 15 0 3.2 15 0 3.2 15 0 2.9 15 0 3.1 15 0 3.0 15 0 3.9 15 0 3.0
ND, not determined
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species

Table A4.10a: Heat stability testing results for pan test line of combination RDTs on a P. falciparum sample at low parasite density (200 parasites/µl).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity

Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band

Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0 0 ND 0 0 ND 0 0 ND 0 0 ND 0 0 ND 0 0 ND 0 0 ND 0 0 ND
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 14 0 1.0 0 0 ND 15 0 1.0 6 0 1.0 10 0 1.0 0 0 ND 7 0 1.0 4 0 1.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0 0 ND 0 0 ND 0 0 ND 0 0 ND 0 0 ND 5 0 1.0 3 0 1.0 0 0 ND
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 10 0 1.0 13 0 1.0 8 0 1.0 7 0 1.0 0 0 ND 3 0 1.0 11 0 1.0 15 0 1.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 0 0 ND 15 0 1.0 12 0 1.0 15 0 1.0 15 0 1.0 15 0 1.0 10 0 1.0 15 0 1.0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 12 0 1.0 12 0 1.0 7 0 1.0 1 0 1.0 0 0 ND 2 0 1.0 8 0 1.0 10 0 1.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0 0 ND 0 0 ND 0 0 ND 0 0 ND 0 0 ND 0 0 ND 0 0 ND 0 0 ND
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 15 0 1.0 15 0 1.0 15 0 1.0 15 0 1.0 6 0 1.0 15 0 1.0 15 0 1.0 14 0 1.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0 0 ND 0 0 ND 1 0 1.0 1 0 1.0 0 0 ND 0 0 ND 0 0 ND 0 0 ND
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 15 0 1.0 15 0 1.0 15 0 1.0 15 0 1.0 15 0 1.0 15 0 1.0 13 0 1.0 15 0 1.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 1 0 1.0 0 0 ND 0 0 ND 1 0 1.0 2 0 1.0 2 0 1.0 0 0 ND 0 0 ND
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 14 0 1.0 14 0 1.0 15 0 1.0 13 0 1.0 13 0 1.0 15 0 1.0 14 0 1.0 15 0 1.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 6 0 1.0 10 0 1.1 13 0 1.4 13 0 1.2 10 0 1.4 10 0 1.2 4 0 1.3 11 0 1.3
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 0 0 ND 0 0 ND 0 0 ND 0 0 ND 1 0 1.0 9 0 1.0 5 0 1.0 0 0 ND
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 15 0 1.9 15 0 1.0 15 0 1.6 15 0 1.0 15 0 1.8 15 0 1.0 15 0 2.0 15 0 1.0
ND, not determined
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

131
 13 2
Table A4.11: Heat stability testing results for P. falciparum test line on a P. falciparum sample at high parasite density (2000 parasites/µl).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity

Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band

Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - HRP2 band 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
RMSM-05071 Access Bio, Inc.
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - Pf-pLDH band 5 0 2.0 5 0 2.0 5 0 2.0 5 0 1.6 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 3.8 5 0 3.8 5 0 4.0 5 0 4.0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 5 0 4.0 5 0 3.8 5 0 4.0 5 0 4.0 5 0 4.0 5 0 3.8 5 0 4.0 5 0 4.0
Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 5 0 4.0 5 0 4.0 5 0 4.0 5 0 3.8 5 0 3.8 5 0 4.0 5 0 4.0 5 0 4.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 3.2 5 0 4.0 5 0 4.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 5 0 4.0 5 0 4.0 5 0 3.6 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 5 0 2.6 5 0 2.8 5 0 3.0 5 0 3.2 5 0 2.8 5 0 3.2 5 0 2.8 5 0 3.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
 Table A4.11 (continued)
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity

Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band

careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 3.8 5 0 4.0 5 0 4.0 5 0 4.0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 3.8 5 0 4.0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 4 1 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0 5 0 4.0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species

Table A4.11a: Heat stability testing results for pan test line of combination RDTs on a P. falciparum sample at high parasite density (2000 parasites/µl).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity

Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band

Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 5 0 1.0 5 0 1.0 5 0 1.0 5 0 1.0 5 0 1.0 5 0 1.0 5 0 1.0 5 0 1.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 5 0 2.2 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 4 0 1.0 5 0 1.0 5 0 1.6 5 0 2.0 5 0 2.0 5 0 1.2 5 0 2.0 5 0 2.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 1.6 5 0 2.0 5 0 2.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 1.6 5 0 2.0 5 0 2.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 5 0 1.6 5 0 2.0 5 0 1.8 5 0 1.8 5 0 1.0 5 0 2.0 5 0 1.8 5 0 1.8
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 5 0 1.8 5 0 1.0 5 0 1.0 5 0 1.0 5 0 1.0 5 0 1.0 5 0 1.2 4 0 1.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 5 0 2.0 5 0 3.0 5 0 2.4 5 0 2.0 5 0 3.0 5 0 2.0 5 0 2.0 5 0 2.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 4 0 1.0 5 0 1.6 5 0 1.2 5 0 1.4 5 0 2.0 5 0 1.8 5 0 1.0 5 0 1.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 5 0 1.2 5 0 1.6 5 0 1.8 5 0 1.0 5 0 2.0 5 0 1.6 5 0 1.0 5 0 1.0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0 5 0 2.0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 5 0 2.8 5 0 2.0 5 0 3.0 5 0 2.0 5 0 3.0 5 0 2.4 5 0 3.0 5 0 2.0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

133
 13 4
Table A4.12: Heat stability testing results for P. falciparum test line on parasite-negative samples.
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
positive
positive
positive
positive
positive
positive
positive

Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - HRP2 band 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
RMSM-05071 Access Bio, Inc.
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - Pf-pLDH band 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 0 0 0 0 2 0 0 0 1 0 0 0 3 0 0 0
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag MPHRPD-01 Meril Diagnostics Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
PALUTOP + pf® 5531 ALLDIAG SA 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 0 0 0 0 2 0 0 0 1 0 1 1 1 0 0 0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
 Table A4.12 (continued)
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
positive
positive
positive
positive
positive
positive
positive

Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

135
 13 6
Table A4.12a: Heat stability testing results for pan or P. vivax test line of combination RDTs on parasite-negative samples.
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
positive
positive
positive
positive
positive
positive
positive

Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 0 0 0 0 1 0 0 0 0 0 3 0 0 0 0 0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 0 0 0 0 2 0 0 0 0 0 1 0 0 0 1 0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 4 0 2 0 4 0 4 0 3 0 3 1 3 0 3 0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 2 0 1 0 2 0 3 0 3 0 2 0 1 0 3 0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 2 0 1 0 1 0 4 0 4 0 3 0 3 0 3 0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Pv and Pan
PALUTOP +4 optima® - Pv-pLDH band 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5499 ALLDIAG SA
PALUTOP +4 optima® - Pan-pLDH band 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species
 Table A4.13: Heat stability testing results for P. falciparum test line on P. vivax samples at low parasite density (200 parasites/µl).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
positive
positive
positive
positive
positive
positive
positive

Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - HRP2 band 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
RMSM-05071 Access Bio, Inc.
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - Pf-pLDH band 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
(continued)

Annexes

137
 13 8
Table A4.13: Heat stability testing results for P. falciparum test line on P. vivax samples at low parasite density (200 parasites/µL).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C (continued)
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
positive
positive
positive
positive
positive
positive
positive

NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0 0 0 0 0 0 0 0 4 0 2 0 0 0 0 0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 Table A4.14: Heat stability testing results for P. falciparum test line on P. vivax samples at high parasite density (2000 parasites/µl).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=2) Lot 2 (n=2) Lot 1 (n=2) Lot 2 (n=2) Lot 1 (n=2) Lot 2 (n=2) Lot 1 (n=2) Lot 2 (n=2)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
positive
positive
positive
positive
positive
positive
positive

Pf only
Adv Dx™ Malaria Pf Rapid Malaria Antigen Detection Test RKMAL017 Advy Chemical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ADVANCED QUALITY™ ONE STEP Malaria (p.f) Test ITP11002-TC25 InTec Products, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Alere™ Malaria Ag P.f 05FK140-40-0 Standard Diagnostics, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Aspen® Malaria Ag Pf AS0015 Aspen Laboratories Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BioTracer™ Malaria P.f Rapid Card 17912 Bio Focus Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf (HRP2) Ag RDT RMOM-03091 Access Bio Ethiopia 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - HRP2 band 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0
RMSM-05071 Access Bio, Inc.
CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-Line - Pf-pLDH band 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
careUS™ Malaria Pf (HRP2) Ag RMO-M05082 WELLS BIO, INC 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
DIAQUICK Malaria P.f. Cassette W06200 DIALAB 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ICT MALARIA P.F. CASSETTE TEST ML01 ICT INTERNATIONAL 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
KHB® Malaria Ag (HRP2) Pf Rapid Test R-409-50-C Shanghai Kehua Bio-engineering Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Malaria Pf Rapid Test GCMAL(pf)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
GMD Malaria Pf test GMDMALPF001 Medical Diagnostech (Pty) Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Malaria HRP2 (P.f) Test W37-C Guangzhou Wondfo Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Test for Malaria Pf HRP-II Ag MERISCREEN Malaria
MPHRPD-01 Meril Diagnostics Pvt. Ltd. 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0
Pf HRP-II Ag
PALUTOP + pf® 5531 ALLDIAG SA 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Parahit f® Ver 1.0 - Dipstick 55IC103-50 ARKRAY Healthcare Pvt Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Parahit® f Ver 1.0 - Device 55IC104-50 ARKRAY Healthcare Pvt Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
SD BIOLINE Malaria Ag P.f. (HRP2/pLDH) 2 Lines 05FK130-40-0 Standard Diagnostics, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
(continued)

Annexes

139
 14 0
Table A4.14: Heat stability testing results for P. falciparum test line on P. vivax samples at high parasite density (2000 parasites/µL).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C (continued)
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=2) Lot 2 (n=2) Lot 1 (n=2) Lot 2 (n=2) Lot 1 (n=2) Lot 2 (n=2) Lot 1 (n=2) Lot 2 (n=2)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
positive
positive
positive
positive
positive
positive
positive

NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0 0 0 0 0 0 1 0 2 0 2 0 0 0 0 0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 Table A4.15: Heat stability testing results for P. vivax test line on P. falciparum samples at low parasite density (200 parasites/µL).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
positive
positive
positive
positive
positive
positive
positive

Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 1 0 3 0 4 0 8 0 3 0 4 0 1 0 0 0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 6 0 5 0 9 0 13 0 10 0 11 0 6 0 8 0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

141
 14 2
Table A4.16: Heat stability testing results for P. vivax test line on P. falciparum samples at high parasite density (2000 parasites/µL).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5) Lot 1 (n=5) Lot 2 (n=5)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
positive
positive
positive
positive
positive
positive
positive

Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 3 0 4 0 5 0 5 0 5 0 5 0 5 0 5 0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 0 0 0 0 1 0 2 0 2 0 0 0 0 0 0 0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0
Pf, Pv and Pan
PALUTOP +4 optima® 5499 ALLDIAG SA 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
 Table A4.17: Heat stability testing results for pan or P. vivax test line of combination tests on a P. vivax sample at low parasite density (200 parasites/µl).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4) Lot 1 (n=4) Lot 2 (n=4)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity

Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band

Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 4 0 1.0 4 0 1.0 0 0 0.0 4 0 1.0 4 0 1.0 4 0 1.0 3 0 1.0 4 0 1.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 4 0 2.0 4 0 1.5 4 0 2.0 4 0 1.5 4 0 2.0 4 0 1.5 4 0 1.8 4 0 1.3
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 3 0 1.0 4 0 1.0 4 0 1.0 4 0 1.0 4 0 1.0 4 0 1.0 4 0 1.0 3 0 1.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 1.8 4 0 1.3 4 0 2.0 4 0 2.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 4 0 2.0 4 0 2.0 3 0 2.0 4 0 2.0 3 0 1.7 4 0 2.0 4 0 2.0 4 0 1.8
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 4 0 1.8 4 0 1.0 4 0 2.0 4 0 1.3 4 0 1.0 4 0 1.0 4 0 2.5 4 0 1.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 4 0 2.0 4 0 1.5 4 0 1.0 4 0 1.8 4 0 1.0 4 0 1.0 4 0 1.5 4 0 1.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 0 0 0.0 2 0 1.0 0 0 0.0 0 0 0.0 0 0 0.0 0 0 0.0 0 0 0.0 0 0 0.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.5 4 0 2.0 4 0 2.5 4 0 2.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 4 0 1.0 4 0 1.0 4 0 1.0 4 0 1.0 4 0 1.0 4 0 1.0 3 0 1.0 4 0 1.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 4 0 1.3 4 0 1.5 3 0 1.0 4 0 1.0 1 0 1.0 4 0 1.0 4 0 1.0 4 0 1.0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 4 0 1.5 4 0 2.0 4 0 2.0 4 0 2.0 4 0 1.8 4 0 1.8 4 0 1.5 4 0 2.0
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 4 0 2.0 4 0 1.0 4 0 2.0 4 0 1.3 4 0 1.0 4 0 1.0 4 0 2.0 4 0 1.8
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 4 0 2.0 4 0 1.8 4 0 2.0 4 0 1.3 4 0 2.0 4 0 1.5 4 0 2.0 4 0 2.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.3 4 0 2.0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 4 0 2.0 4 0 1.5 4 0 2.0 4 0 1.3 4 0 1.5 4 0 1.0 4 0 2.0 4 0 1.8
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 4 0 1.3 4 0 2.0 4 0 1.8 4 0 1.0 4 0 1.5 4 0 1.3 4 0 1.0 4 0 1.0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 0 0 0.0 0 0 0.0 0 0 0.0 1 0 1.0 0 0 0.0 3 0 1.0 0 0 0.0 0 0 0.0
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 4 0 1.0 4 0 1.0 4 0 1.0 4 0 1.0 4 0 1.8 4 0 1.0 4 0 1.0 4 0 1.0
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 4 0 1.5 4 0 2.0 4 0 1.8 4 0 1.0 4 0 1.3 4 0 1.0 4 0 2.0 4 0 1.3
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 4 0 1.0 4 0 1.0 4 0 1.8 4 0 1.0 4 0 2.0 4 0 1.0 4 0 1.0 4 0 1.0
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 4 0 2.0 4 0 1.8 4 0 2.0 3 0 1.0 4 0 2.0 4 0 1.5 4 0 1.8 4 0 1.0
Pf, Pv and Pan
PALUTOP +4 optima® - Pv-pLDH band 4 0 2.0 4 0 1.8 4 0 2.0 4 0 1.0 4 0 1.3 4 0 1.8 4 0 2.0 4 0 1.0
5499 ALLDIAG SA
PALUTOP +4 optima® - Pan-pLDH band 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.0 4 0 2.8 4 0 2.0
ND, not determined
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

143
 14 4
Table A4.18: Heat stability testing results for pan or P. vivax test line of combination tests on a P. vivax sample at high parasite density (2000 parasites/µL).
Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35°C and 45°C
Baseline testing 35°C 45°C Room temperature
Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15) Lot 1 (n=15) Lot 2 (n=15)
Product Product code Manufacturer

No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.

invalid
invalid
invalid
invalid
invalid
invalid
invalid
invalid

positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity
positive
intensity

Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band
Mean band

Pf and Pan
Adv Dx™ Malaria Pan/Pf Rapid Test Detection Kit RKMAL016 Advy Chemical Private Limited 2 0 3.0 2 0 2.5 2 0 2.5 2 0 2.0 2 0 2.5 2 0 3.0 2 0 2.5 2 0 2.0
Alere Trueline™ – Rapid test kit for Malaria Ag Pf/Pan (HRP-II/pLDH) 05FK60AI-40 Alere Medical Private Limited 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 4.0 2 0 3.0 2 0 3.5 2 0 3.0
AllTest™ Malaria P.f./Pan Rapid Test Cassette IMPN-402 Hangzhou AllTest Biotech Co. Ltd. 2 0 2.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0
Asan Easy Test® Malaria Pf/Pan Ag AM4650-K ASAN Pharmaceutical Co., Ltd 2 0 4.0 2 0 3.5 2 0 3.5 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0
Aspen® Malaria Ag Pf/Pv AS0060 Aspen Laboratories Pvt. Ltd. 2 0 4.0 2 0 4.0 2 0 3.5 2 0 3.0 2 0 4.0 2 0 3.0 2 0 4.0 2 0 3.0
BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C32RHA25 RapiGEN Inc. 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 2.0 2 0 3.0 1 0 3.0 2 0 3.0
Biosynex® Malaria Pf/Pan 0584_K25 Biosynex 2 0 3.0 2 0 3.0 2 0 3.5 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0
BioTracer™ Malaria P.f/PAN Rapid Card 17012 Bio Focus Co., Ltd. 2 0 4.0 2 0 4.0 2 0 4.0 2 0 2.0 2 0 3.5 2 0 3.0 2 0 3.5 2 0 4.0
CareStart™ Malaria Pf/PAN (pLDH) Ag RDT RMLM-05071 Access Bio, Inc. 1 0 1.0 2 0 1.0 2 0 1.0 2 0 1.0 1 0 1.0 1 0 1.0 0 0 0.0 1 0 1.0
CareStart™ Malaria Screen RDT RMAM-05071 Access Bio, Inc. 2 0 4.0 2 0 4.0 2 0 4.0 2 0 3.5 2 0 4.0 2 0 4.0 2 0 4.0 2 0 4.0
ICT MALARIA DUAL TEST ML03 ICT INTERNATIONAL 2 0 3.0 2 0 2.0 2 0 3.0 2 0 2.0 2 0 2.0 2 0 2.0 2 0 3.0 2 0 2.0
Is It... Malaria Pf PAN MPFPAN050 Medsource Ozone Biomedicals Pvt. Ltd. 2 0 3.5 2 0 4.0 2 0 3.5 2 0 2.5 2 0 3.5 2 0 3.5 2 0 4.0 2 0 4.0
NG-Test MALARIA Pf/Pan (pLDH) NGB-MAL-W23-005 NG Biotech 2 0 2.5 2 0 3.0 2 0 2.5 2 0 2.0 2 0 2.0 2 0 2.0 2 0 2.0 2 0 2.0
Rapid 1-2-3 HEMA® CASSETTE MALARIA PF/PAN MAL-PF/Pan-CAS/25 Hema Diagnostic Systems 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0
Pf and Pv
ADVANCED QUALITY™ ONE STEP Malaria (p.f/p.v.) Tri-line Test ITP11003-TC25 InTec Products, Inc. 2 0 4.0 2 0 3.5 2 0 4.0 2 0 3.5 2 0 3.5 2 0 3.0 2 0 4.0 2 0 3.5
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) C60RHA25 RapiGEN Inc. 2 0 4.0 2 0 4.0 2 0 4.0 2 0 4.0 1 1 4.0 2 0 4.0 2 0 4.0 2 0 3.5
Biosynex® Malaria Pf/Pv 0581_K25 Biosynex 2 0 3.0 2 0 3.0 2 0 3.5 2 0 2.5 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT RMVM-03091 Access Bio Ethiopia 2 0 4.0 2 0 3.0 2 0 3.5 2 0 3.0 2 0 3.0 2 0 3.0 2 0 2.0 2 0 3.0
CareStart™ Malaria Pf/Pv (HRP2/pLDH) Ag. Combo RDT RMVM-05072 Access Bio, Inc. 2 0 4.0 2 0 4.0 2 0 4.0 2 0 3.5 2 0 4.0 2 0 4.0 2 0 4.0 2 0 4.0
careUS™ Malaria Combo Pf/Pv (HRP2/pLDH) Ag RMV-M05082 WELLS BIO, INC 2 0 4.0 2 0 3.0 2 0 3.5 2 0 2.5 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0
Malaria Pf/Pv Rapid Test GCMAL(pf/pv)-402a Zhejiang Orient Gene Biotech Co., Ltd. 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 1 1 2.0 2 0 3.0 2 0 3.0
MD Malaria Pf/Pv (pLDH) Test MDMALLDH004 Medical Diagnostech (Pty) Ltd 0 0 0.0 0 0 0.0 0 0 0.0 1 0 1.0 0 0 0.0 0 0 0.0 0 0 0.0 0 0 0.0

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
One Step Malaria HRP2/pLDH (P.f/P.v) Test W056-C Guangzhou Wondfo Biotech Co., Ltd. 2 0 3.0 2 0 3.0 2 0 2.5 2 0 2.5 2 0 3.0 2 0 3.0 2 0 3.0 2 0 2.5
One Step Test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag MFLRPD-02 Meril Diagnostics Pvt. Ltd. 2 0 3.0 2 0 3.5 2 0 3.0 2 0 3.0 2 0 2.5 2 0 2.0 2 0 3.5 2 0 3.0
QuickProfile™ Malaria Pf/Pv Antigen Test 71050 Lumiquick Diagnostics Inc. 2 0 3.0 2 0 3.0 2 0 3.0 2 0 2.0 2 0 2.5 2 0 3.0 2 0 3.0 2 0 2.5
Rapid Test Kit for Malaria Ag Pf/Pv-Alere Trueline Malaria Ag Pf/Pv 11108191040 Alere Medical Private Limited 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.5 2 0 3.0 2 0 3.0 2 0 3.0
Pf, Pv and Pan
PALUTOP +4 optima® - Pv-pLDH band 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 3.0 2 0 4.0 2 0 3.0
5499 ALLDIAG SA
PALUTOP +4 optima® - Pan-pLDH band 2 0 3.0 2 0 4.0 2 0 4.0 2 0 3.0 2 0 4.0 2 0 4.0 2 0 4.0 2 0 4.0
Pf, Plasmodium falciparum  Pv, Plasmodium vivax  pan, Plasmodium species
Annex 5: Introducing RDT-based malaria diagnosis
into national programmes
Introduction of parasite-based diagnosis at small clinics and diagnosis can hinder strengthening of appropriate malaria
at village level for case management poses many challenges, case management. A focal person or persons should be
not only of logistics but also in managing the health-seeking available to coordinate the overall implementation plan and
and health-providing behaviour of patients and health to ensure that the various agencies involved understand the
workers. These can be addressed by a clear, time-bound process and their own roles.
strategic plan covering planning, implementation, monitoring
and evaluation of the diagnosis programme, which must begin Examples of successful wide-scale introduction of malaria
well before RDTs are procured. Furthermore, funding for the RDTs by various national programmes and comprehensive
programme must include a significant component for planning technical guidance on achieving universal access to malaria
and coordination, sensitization, information, education and diagnostic testing have been reported (14–15). Figures A5.1
communication, training, quality assurance, monitoring, and A5.2 give examples of the steps and timelines for RDT
supervision and logistics, in addition to procurement. In implementation and budget components for a malaria diag-
the absence of such funding, much of the expenditure on nosis programme, respectively. These will have to be modified
RDTs will be wasted, and loss of confidence in RDT-based considerably for each programme.

Key challenges
Changing past thinking that “fever equals malaria
unless proven otherwise”.
Introducing RDTs will disprove this statement. To have an impact on malaria
diagnosis and treatment, RDTs must be seen to provide an accurate diagnosis
by both health workers and patients, that is, they must be as good or better
than those relied on previously. A health worker requires a good alternative
to antimalarial medicines for the management of parasite-negative febrile
patients. To achieve and maintain confidence in RDT-based diagnosis, a
good quality assurance system must be in place. There must be satisfactory
education of health workers and widespread community sensitization.
Health workers should have understanding of other causes of fever in order
to devise appropriate management algorithms for parasite-negative cases.

Changing and enforcing regulatory requirements

At the national level, regulation might be required to control the importation
and use of malaria RDTs, and new procedures for storage, distribution and
inventory management, such as those used for medicines, might be necessary.

Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 145
 14 6
Figure A5.1. Example of malaria RDT implementation steps and timelinea
RDT IMPLEMENTATION TIMELINE

Coordinating group
Appoint malaria diagnosis coordinator(s)
Policy recommendations Written MoH endorsement

Programme planning
Guidelinesb Written MoH endorsement
Case management of fever of unknown origin
Case management of malaria
RDT (and microscopy) quality assurance
RDT transport and storage
Decide districts for initial / phased implementation
Fever management algorithm Written MoH endorsement
Community sensitization
General health care providers’ education
Determine / designate transport and storage methods

Regulatory issues
Define collaborative roles (NMP and regulatory body)
Write/adopt regulatory guidelines
Create RDT registry for reference
Dsseminate regulatory criteria

Product selection, supply chain management

Select several products
Samples for ease-of-use assessment
Final decision on RDT
Negotiate specifications with manufacturer
Competitive bidding and procurement Dependent on registration process

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Receive first batch (of staggered delivery)
Distribution to field
Procure gloves
Procure sharps boxes
Procure other associated materials

RDT quality control

Write sentinel site SOP
Set up/engage field-based quality control monitoring sites
Decide on lot-testing site Determine site Commence testing
Post-marketing surveillancec
 Figure A5.1 (continued)
Training
Conduct case management training for fever May be conducted earlier, or already in place
Modify RDT instructions and training manual
Field-test modified training/instructions
Training of trainers and supervisors
Health worker training

Advocacy, communication, social mobilization

Engaging civil society organizations
Community sensitization
Engaging opinion leaders
General health care education

Monitoring and evaluation

Develop/adopt appropriate record forms
Define methods for capturing different indicators
Integrate RDTs into the routine health information
management system
Plan for a post-introduction programme review

MoH, ministry of health; NMP, national malaria programme

a Adapted with permission from FIND and Uganda National Malaria Control Programme
b May already be in place
c Sentinel site microscopy, possibly positive control wells in future

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
Annexes

147
 Figure A5.2. Components of the budget for a malaria diagnosis programmea
Activities for
Activities specific to Activities specific to
Component management of malaria
microscopy RDTs
and non-malaria fevers
Preparation of technical guidelines, standard operating procedures and checklists
Guidelines Laboratory supervisionb RDT transport and storage Fever management algorithm

Standard operating procedures for Other tests used at primary

Microscopy performance RDT performance
diagnostic testing care level

Proficiency testing, validation

Other standard operating procedures RDT storage
of routine slide results

Training manuals for

Training manual for
Training material Training manual for RDTs integrated management of
microscopy
fevers

Checklists for supervision Laboratory visitsb Health facility visits

Procurement and supply of commodities
Urine dipsticks, haemoglobin
Microscopes and related
Diagnostic tests RDT kits meter, haematocrit meter,
supplies
glucometer

Antibiotics, zinc, inhaled

Medicines Artemisinin-based combination therapy
salbutamol, rehydration salts

Other commodities Gloves, lancets, alcohol, cotton-wool, timers, sharps boxes

Distribution of commodities to the field All items listed above

Quality management system
Pre-shipment testing Lot-testing

Training of focal people Quality management system for focal people

Monitoring the quality management Quality monitoring supervision visits and compilation of
system health information management data
Training of health workers
Tutors for RDT performance outside laboratories and clinical
Training of tutors Expert microscopists
management of fever cases

Training of health workers Microscopists Health workers Clinicians

Training of supervisors Laboratory supervisorsb Clinical supervisors

Supervision
Supervisory visits Laboratory visitsb Health facility visits
Advocacy, communication and social mobilization
Communication on other
Design of strategies and material Communication on the need for malaria testing
causes of fever

Dissemination of key messages Through each delivery channel

Monitoring and evaluation
Updating the health information Add row for RDTs in laboratory report and column Column for other test results
management system for malaria test results in clinicians’ book in clinicians’ book

Train health workers in the new health Training of person in charge or focal person for reporting on
information management system health information management in health facilities
a Adapted with permission (14)
b For simplicity, activities specific to laboratories are listed under ‘Microscopy’, although both microscopy and RDT are generally performed in laboratories.

14 8 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
References
1. Gamboa D, Ho MF, Bendezu J, Torres K, Chiodini PL, Barnwell JW, et al. A large proportion of P. falciparum isolates in the
Amazon region of Peru lack pfhrp2 and pfhrp3: implications for malaria rapid diagnostic tests. PLoS One, 2010:5:e8091.
2. Bharti PK, Chandel HS, Ahmad A, Krishna S, Udhayakumar V, Singh N. Prevalence of pfhrp2 and/or pfhrp3 gene deletion
in Plasmodium falciparum population in eight highly endemic states in India. PLoS One 2016;11:e0157949.
3. Berhane A, Mihreteab S, Mohammed S, Embaye G, Hagos F, Zehaie A, et al. PfHRP2 detecting malaria
RDTs: alarming false negative results in Eritrea. Poster 879. In: 65th annual meeting of the American Society for
Tropical Medicine and Hygiene. Oakbrook Terrace, IL; 2016.
4. Cheng Q, Gatton M, Barnwell J, Chiodini P, McCarthy J, Bell D, et al. Plasmodium falciparum parasites lacking
histidine-rich protein 2 and 3: a review and recommendations for accurate reporting. Malaria J 2014;13:283.
5. Parr JB, Verity R, Doctor SM, Janko M, Carey-Ewend K, Turman BJ, et al. Pfhrp2-deleted Plasmodium falciparum
parasites in the Democratic Republic of Congo: a national cross-sectional survey. J Infect Dis. 2016;. doi:10.1093/infdis/
jiw538
6. Amoah LE, Abankwa J, Oppong A. Plasmodium falciparum histidine rich protein-2 diversity and the implications for
PfHRP 2: based malaria rapid diagnostic tests in Ghana. Malaria Journal. 2016;15:101. doi:10.1186/s12936-016-1159-z.
7. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 1 (2008).
Geneva: World Health Organization; 2009.
8. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 2 (2009).
Geneva: World Health Organization; 2010.
9. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 3 (2010–11).
Geneva: World Health Organization; 2011.
10. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 4 (2012).
Geneva: World Health Organization; 2012.
11. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 5 (2013).
Geneva: World Health Organization; 2014.
12. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 6 (2014–2015).
Geneva: World Health Organization; 2015.
13. Recommended selection criteria for procurement of malaria rapid diagnostic tests. Geneva: World Health Organization;
2016.
14. Universal access to malaria diagnostic testing: an operational manual. Geneva: World Health Organization; 2011.
15. Thiam S, Thior M, Faye B, Ndiop M, Diouf ML, Diouf MB, et al. Major reduction in anti-malarial drug consumption in
Senegal after nation-wide introduction of malaria rapid diagnostic tests. PLoS One 2011;6:e18419.

Annexes

Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016) 149
 Notes

15 0 Malaria Rapid Diagnostic Test Performance – Results of WHO product testing of malaria RDTs: round 7 (2015–2016)
151
Global Malaria Programme FIND
World Health Organization Campus Biotech
20, Avenue Appia Building B2, Level 0
1211 Geneva 27 9, Chemin des Mines
Switzerland 1202 Geneva, Switzerland
P.O. Box 87
infogmp@who.int CH - 1211 Geneva 20
www.who.int/malaria
T: + 41 (22) 710 05 90
info@finddiagnostics.org
www.finddiagnostics.org

ISBN 978 92 4 151268 8