Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

ADMINISTRATIVE ORDER
No. 2016 - OOH

SUBJECT: Guidelines for the Nationwide Implementation of Dengue Rapid

Diagnostic Test (RDT)

I. RATIONALE
The Philippines ranked first in the Western Pacific Region among countries with most
number of dengue cases from 2013 to 2015. A total of 200,415 suspected dengue cases
and 598 deaths were reported nationwide in 2015. There is no specific medicine against
dengue and treatment for dengue involves supportive measures such as fluid management
and monitoring of warning signs. Early detection and prompt management are very
critical. Mortality rate is reduced to <l% as compared to 20% death rate if proper
management is initiated early (WHO, 2016).

The introduction of the Rapid Diagnostic Test (RDT) for Dengue Non-Structural protein
1 (NSI) antigen, complements the overarching 4S Strategy of the National Dengue
Prevention and Control Program specifically in seeking early consultation. The 4S
Strategy includes: Search and Destroy, Seek Early Consultation, Self-Protection
Measures and Saying Yes to fogging when there is an impeding outbreak. Through the
Dengue NSI RDT, test results are produced within the day making early detection,
prompt treatment and timely referral possible.

The early recognition of dengue through clinical examination, complemented with a

simple and rapid diagnostic tool is the cornerstone of its early diagnosis. Hence, the
introduction and adoption of Dengue NSl RDT by the National Dengue Prevention and
Control Program shall upgrade our existing facilities at the point-of-care and strengthen
the diagnosis and management capabilities of our Rural Health Units.

II. OBJECTIVE
This issuance shall provide technical and procedural guidelines on the nationwide
implementation of Rapid Diagnostic Test at the Rural Health Units (RHUs) and other
point of care.

III. SCOPE
This issuance shall apply to the DOH - Central Office, Regional Offices, DOH —
ARMM, Philippine Health Insurance Corporation and Rural Health Units.

IV. DEFINITION OF TERMS:

1. Rapid Diagnostic Test (RDT) — a collection of reagents and other materials for
in- vitro diagnostics, intended to be used for the detection of either antigen or
antibody from clinical samples, usually blood, within a shorter period.

2. Dengue Non-Structural protein 1 (NSI) RDT- is an immuno-chromatography

based test used to detect the Dengue virus non-structural protein 1 antigen in
human serum, plasma, or whole blood to suggest acute Dengue infection.

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 3. Suspected Dengue Case- a person with an acute febrile illness of 2-7 days
duration with 2 or more of the following: headache, body malaise, retro-orbital
pain, myalgia, arthralgia, anorexia, nausea, vomiting, diarrhea, flushed skin, rash
(petechial, Hermann’s sign). (Refer to PIDSR Manual of Procedures, 3"d Edition
2014).

4. Probable Dengue Case- a suspected case and with a laboratory test result of at
least CBC with leucopenia with or without thrombocytopenia and/or a positive
Dengue NS1 antigen test or dengue IgM antibody test. (Refer to PIDSR Manual of
Procedures, 3rd Edition 2014).

5. Confirmed Dengue Case- a suspected case with positive result for viral culture
isolation, and/or Polymerase Chain Reaction (PCR). ( Refer to PIDSR Manual of
Procedures, 3"d Edition 2014).

V. GENERAL GUIDELINES
1. Aligned with the Dengue Program 4S strategy of “Seeking Early Consultation”, a
suspected dengue case shall be eligible for Dengue NS1 RDT test if the signs
and/or symptoms manifest between day one and day five of the illness. THE
DENGUE NS1 RDT SHALL NOT BE USED TO A PATIENT BEYOND FIVE
DAYS OF ILLNESS.
2. Dengue NS1 RDT shall be used in support for the clinical diagnosis of suspected
dengue. However, it shall not be the sole basis for the final diagnosis of dengue.
(RT-PCR, Hemagglutination Inhibition test and virus isolation remain to be the
“confirmatory test” for the detection of dengue virus in human blood.)
3. Dengue NS1 RDT shall be performed by a health care worker, such as medical
technologist, nurse, midwife, barangay health worker (BHW), and other health
professional who has undergone appropriate training on its use.
4. The performance of Dengue NS1 RDT shall be supported by a quality assurance
system.

VI. SPECIFIC GUIDELINES

A. Screening and Early Diagnosis of Patient
1. An initial assessment of a suspected dengue case based on history of illness and
physical examination shall be guided by AO 2012-0006: Revised Dengue Clinical
Case Management Guidelines 2011 prior to using dengue NS1 RDT. (Refer to
Annex 1: Guide in the Initial Assessment of Suspected Dengue Case,) The Dengue
NS1 RDT shall only be performed to a patient who fits the criteria of a
SUSPECTED DENGUE CASE.
2. Serum, plasma or whole blood specimen shall be used for Dengue NS1 RDT.
Capillary blood shall be used if the health facility has limited laboratory
equipment or there is no medical technologist available to perform the
venipuncture.
3. A positive result shall be defined as probable dengue case. However, a negative
result does not rule out Dengue infection and therefore shall be correlated with the
clinical information of the patient. The health provider shall rule out a window or
convalescence period, wherein the virus may no longer be detected and antibody
titer starts to rise. In this case, other laboratory tests may be performed.

B. Performing the Test

1. Specimen from the capillary blood may be obtained from a finger prick. (Refer to
Annex 2: Methods for Collecting Specimen.)
2. The dengue NS1 RDT shall be performed and the result shall be made available
during the time of consultation. It shall observe the same day testing and
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releasing of result.

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 C. Recording and Reporting
1. All positive results shall be recorded as PROBABLE DENGUE CASE, while
negative cases shall be recorded as SUSPECTED DENGUE CASE and shall be
reported using the PIDSR Case Report Form (CRF) (Refer to Annex 4). Those
with invalid interpretation after the second test shall still be recorded as
SUSPECTED DENGUE CASE.
2. For interpretation of invalid results, the test shall be repeated on the same day
when the first test is done. The result of the second test shall be used as basis of
the final interpretation. Two invalid results shall still be classified as
SUSPECTED DENGUE CASE and shall be managed accordingly.
3. The frequency for reporting shall follow the PIDSR reporting system.

D. Quality Assurance Program

1. Lot Testing
a. Pre-shipment lot testing:
RITM shall subject fifteen percent (15%) of RDT kits to evaluation prior to
shipment to health facilities.
b. Post-shipment lot testing:
RITM shall evaluate the RDT kits sent to three selected health facilities
and then returned to RITM.
c. Report of the pre-shipment and post shipment testing shall be available
after 2 weeks of receipt of the RDT kits.
2. External Quality Assurance
a. RITM shall conduct a proficiency testing to health facilities at least every
two years.
b. Health facility passing the EQA shall receive a certificate valid for 2 years.
c. Health facility that will not pass the EQA shall subject to onsite
assessment, retraining, and close monitoring of performance until all
recommendations are satisfactorily met.
3. Validation
a. RITM and DPCB shall select 50 health facilities to send samples for
validation.
b. Selected health facility shall store one sample per week collected from the
agreed day and shall be sent to RITM on a quarterly basis.
c. RITM shall perform testing of these samples.

VII. ROLES AND RESPONSIBILITIES

A. Department of Health (DOft)
1. Disease Prevention and Control Bureau (DPCB)
The DOH-DPCB shall be responsible for the overall execution of the policy
and guidelines on the introduction of Dengue Rapid Diagnostic Test (RDT)
for the early diagnosis of dengue infection at the point of care level. The
DPCB shall undertake the following tasks:
a) Lead in the formulation and dissemination of policy and guidelines for the
use of dengue RDT;
b) Facilitate the orientation and/or training of concerned Regional Offices;
c) Oversee the procurement and distribution of dengue RDT supplies from
the central to the peripheral health units. Ensure that the supplies are
stored at room temperature not exceeding 30°C;
d) Provide funds and coordinate with RITM for the quality assurance system
of the dengue RDT kits; and
e) Coordinate with EB for the data about dengue cases specifically on the
PROBABLE DENGUE CASES. Monitor and evaluate the implementation

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 jointly with the region and provincial/city/municipal health offices and
concerned technical partners.

2. Research Institute for Tropical Medicine (RITM)

a) Provide technical assistance for the implementation of the RDT testing in
the following areas: training on proper collection, handling, trañlpT›rt dññ
storage of specimens and kits; testing; and reporting of results. '. !' =- i› !:-.
'
b) Perform lot testing of RDTs pre and post shipment.
c) Provide proficiency panel to serve as EQAS to health facilities.
d) Provide feedback and recommendations on the performance of RDT and
health facilities to DPCB.

3. Epidemiology Bureau (EB)

a) Provide accurate, timely and complete data as basis for program use such
as policy decisions, strategic directions and prioritization of resources;
b) Enhance the current PIDSR dengue case definition to include reporting of
PROBABLE DENGUE CASE based on the result of the dengue RDT and
reporting form; and
c) Strengthen reporting of dengue cases at the RHU level using the PIDSR
reporting system.

4. PhilHeaIth
a) Review as necessary the dengue benefit package to include dengue RDT
result as one of the basis of claim both in public and in private sectors.

5. Department of Health Regional Offices (DOH-RO)

a) Ensure the dissemination, orientation and/or training of the Regional
Office staff on the dengue RDT implementation policy and guidelines for
its adoption and implementation in different localities within their
respective regions;
b) Integrate the monitoring of dengue RDT implementation in their existing
monitoring teams;
c) Ensure the availability and continuous supply of dengue RDT kits at the
RHUs for their regular provision of dengue services;
d) Strengthen existing communication/advocacy plans to continuously promote
the 4S Laban sa Dengue Strategy alongside with the use of dengue RDT;
e) Support and ensure the implementation of the quality assurance system for
dengue RDT; and
f) Ensure timely submission of dengue report using PIDSR reporting system
including dengue RDT data.

B. Local Government Units

1. Provincial/City/Municipal Health Office (P/C/MHO)
a) Strengthen existing communication/advocacy plans to continuously
promote the 4S Laban sa Dengue Strategy alongside with the use of
dengue RDT;
b) Conduct orientation/training of concerned staff on the use of dengue RDT;
c) Advocate with municipalities/cities to adopt and support the use of dengue
RDT;
d) Support the quality assurance system of dengue RDT; and
e) Provide weekly report to the region using the PIDSR reporting system.

2. Rural Health Units (RHUs)

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a) Strengthen existing communication/advocacy plans to continuously
promote the 4S Laban sa Dengue Strategy alongside with the use of den e
RDT;

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 b) Implement the use of dengue RDT for screening and early diagnosis of
dengue cases;
c) Ensure proper storage of dengue RDT kits to ensure longer shelf life; and
d) Ensure timely submission of dengue report using PIDSR reporting system
including dengue RDT data.

VIII. REPEALING CLAUSE

No previous Orders inconsistent in part or in whole to this Administrative Order are being
rescinded or amended.

IX. EPPECTIVITY
This Order shall take effect immediately.

PAULYN E . ROSELL-UBIAL, MD, MPH, CESO II

Secretary of Health

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 ANNEXES

Annex 1. Guide in the Initial Assessment of a Suspected Dengue

Case (Please refer to Administrative Order No. 2012-0006)

Include both w ith w arnf ng and w fWho u/ w arnfng s f gns as per AO No. 2012-0006
Patient history • Date of onset of
should include: fever/illness o Quantity of oral
intake
• Assessment of dengue “warning signs”
• Diarrhea
• Seizures, impaired consciousness, behavioral changes
• Urine output (frequency, volume and time of last voiding)
• Other important relevant histories:
o Family member/s or neighbors with dengue, or travel to
dengue- endemic areas
o Co-existing conditions such as infancy, pregnancy, obesity,
diabetes mellitus, hypertension, etc.
o Jungle trekking and swimming in waterfall (consider
leptospirosis, typhus, malaria)
o Recent unprotected sexual or drug use behavior (consider acute
HIV seroconversion illness)

Annex 2: Methods for Collecting Specimen

1. Serum samples
a. Collect 3 to 5ml of whole blood using red or yellow top tubes following the
usual guidelines for venipuncture. Allow blood to clot at room temperature for
30 minutes.
b. Process into serum.
c. Aliquot at least lml of serum for validation testing in RITM.
2. Capillary blood samples
a. Collect at least 3 drops of capillary blood following the usual guidelines for
capillary blood collection.
b. The puncture should be one quick, continuous and deliberate stroke, to achieve a
good flow of blood and to prevent the need to repeat the puncture.
c. Wipe away the first drop of blood because it may be contaminated with tissue
fluid or debris.
d. Avoid squeezing the finger or heel too tightly because this dilutes the specimen
with tissue fluid (plasma) and increases the probability of haemolysis
e. Place 3 drops of blood directly onto the Dengue NSl-Ag RDT sample well.

Methods for Testing Specimen

1. PRE-ANALYTIC
a. Bring out the Dengue NSl-Ag RDT kit from the refrigerator and equilibrate at
room temperature for 30 minutes. Do not perform the test unless the kit is at
room temperature (20-25 °C).
b. Mix by vortex mixer and spin down the samples for around 10-20 seconds.
c. Prepare the working area: place the absorbent liner with biohazard bags on top
of the bench.
 d. Prepare test protocol by filling up all information and arrange samples in the
same order as reflected in the testing protocol.

2. ANALYTIC
a. Remove the cassette from the foil pouch and place it on a table just prior to use.
b. Label the cassette with the corresponding Laboratory ID.
c. Place 3 drops of serum or whole blood into the sample well. If using a
micropipette, add l00ul of serum or whole blood.
d. Incubate at room temperature for 20 minutes.
e. Read the results by grading the intensity of the band as follows:

Absence of pink band

+/- Faint/shadow band
+ Faint full band
Light pink band
Pink band
Dark pink band

f. Record the reading into the protocol.

g. A second reader is to validate the results.

3. POST ANALYTIC
a. Results are to be interpreted as follows:

Result Appearance Interpretation Recommendation

Two purple band at •{ Positive Report as Dengue NSl-
C and T zones , I* Ag Positive
One purple band at Report as Dengue NSl-
C zone , Ag Negative
No visible band “" Invalid Review and repeat the
test. The procedures may
One purple band at Invalid not follow correctly or
T zone
the kit has deteriorated.

Specimen Handling, Transport and Storage

A. Handling and Storage of Dengue NS l-Ag RDT

1. The Dengue NS l-Ag RDT kits shall be transported at temperatures between 2-25°C.
2. The Dengue NSI-Ag RDT kits shall be stored inside a refrigerator between 2-8°C
until expiration date.
3. A single pouch of RDT corresponds to the number of samples to be tested. The
RDTs shall not be repeatedly taken in and out of the refrigerator to maintain its
stability.

B. Storage and Transport of Serum Samples for Validation

1. Aliquots of samples stored for validation testing shall be sent to RITM following
usual system of sample referral.
2. The vials shall be placed inside a resealable plastic bag and sent together with the
information sheet.
3. Place the bag into the transport box with 4 to 6 frozen ice packs.
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 Annex 3: Dengue RDT Laboratory Request Form

To be filled out by Health Worker Case Number:

Name of Collection Unit: RHU- STA. TERESITA Date of Request:

Name of Requesting Physician: Contact #:

Name of Patient: Age: Sex: [ ] M [ ] F

Address: Contact #:

Signs and Symptoms: [ ] fever: number of [ ] body malaise

days: [ ] retro-orbital pain
[ ] headache [ ] anorexia
[ ] muscle pain [ ] vomiting
[ ] join pain [ ] flushed skin
[ ] diarrhea [ ] others:
[ ] rash

Duration of Signs & Symptoms: days

Reason for Examination: [ ] Diagnosis Type of Specimen: [ ] venous blood, mL

[ ] Follow up [ ] Capillary blood, mls

Repeat Collection? [ ] No [ ] Yes Reason:

Test Requested: Dengue NSI RDT Specimen Date Collection:

Name of Specimen Collector: Designation:

Signature over Printed Name

Cut here

REPUBLIC OF THE PHILIPPINES

PROVINCE OF BATANGAS
MUNICIPALITY OF SANTA TERESITA
MUNICIPAL HEALTH OFFICE

Dengue RDT Laboratory Result Form

Name of Patient: ____________________________ Case Number: ____________

Age:____ Sex: [ ] M [ ] F Date Received: ___________

Laboratory Result:

DENGUE NS1 Ag : _____________

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Date of Examination: ______________ Examined by: JUDELYN G. MANUEL, RMT
Signature over Printed Name

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Annex 4: PIDSR Dengue Case Report Form

we.

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Annex S. Dengue NSI RDT Registry

Rzaxzks
 Instruction on How to Use the Dengue NS1 RDT Registry

This Dengue NSI RDT Registry is to be filled-out properly using blue or black pen by the
Medical Technologist or trained worker assigned in the facility to perform the Dengue NS l
Rapid Diagnostic Test (RDT). Positive examination result should be written in the Registry
using red pen for easier identification.
1. Write down the name of region, province and municipality where the facility is
located.
2. Write down the name of the person who is filling-out the form and his/her contact
number.
3. Write down the quarter and year the Dengue NSI RDT was performed. It is
advisable to use a new sheet of the Registry for a different quarter.
4. Fill in columns as follows:

Column 1. Date of Collection/ Examination —date the specimen is collected

and examined. Write date in mm/dd/yy format.
Column 2.’ Case Number- consecutive number assigned to a person as s/he
comes in the facility. One person shall receive one case number
only regardless of how many times he/she submitted specimens for
testing. Write Case Number using the following format: year-xxxx.
(ie.2016-0001, 2016-0002, and so on)
Column 3. Write family name first, all in capital letters, then the first name and
middle initial of the patient.
Column 4. Age-write age in complete years as of the last birthday or months if
less than one (I) year old.
Column 5: Sex-write F for female, write M for male.
Column 6. Address- write complete address of the person and his/her contact
number.
Column 7: Duration of Signs and Symptoms- number of interval days since the
first signs and symptoms appear and before the blood specimen is
drawn.
Column 8. Result of Dengue NSI RDT- write P for positive result, N for
negative result and I for indeterminate result. Repeat test if the
result is indeterminate and follow the same instructions above in
writing result.
Column 9: Examined by-write name of the Medical Technologist or health
worker who performed the test. Do not affix signature only.
Case Classification-identify patient as follows:
a. Dengue without Warning Signs
• Suspect case- person with acute febrile illness of 2-7
days duration plus two of the following: headache, body
malaise, myalgia, arthralgia, retro-orbital pain, anorexia,
nausea, vomiting, diarrhea, flushed skin, rash (petechial,
Herman’s sign). Write S for suspect case.
• Probable case-a suspect case with a laboratory test result
positive with Dengue NS l RDT. Write P for probable
dengue case.
b. Non-Dengue case- a suspect case ruled out for dengue
disease and becomes suspect for other diseases upon result
of Dengue NS I RDT. Write ND for Non-Dengue case.
Column 11.
Decision of Health Worker- health worker decides on the
intervention to be provided to the person after laboratory test that
may include the following:
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 •Home Care/ Home Management. Write HC or HM.
•Refer to physician or hospital. Write Refer.
•Consider other diseases or other tests. Write other disease
or other test.
Column 12. Remarks- write any remarks including but not limited to what
happened to the specimen or patient (ie. repeat collection, repeat
examination, rejected specimen, etc.)

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Annex 6: Dengue NSI RDT Monthly Consolidation Report Form

D £N TbTNSI RDT

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