Please only refer to the current product lot insert enclosed with the kits package for execution

and reporting

0123 130219004M: 100 tests

130619004M: 150 tests

TM
MAGLUMI HIV Ab/Ag Combi (CLIA)
INTENDED USE
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The kit has been designed for the simultaneously qualitative determination of HIV-1 p24
antigen and antibodies to HIV-1, HIV-2 in human serum and plasma.
The test has to be performed on MAGLUMI series Fully-auto chemiluminescence
Shenzhen New Industries immunoassay (CLIA) analyzer (Including Maglumi 600, Maglumi 800, Maglumi 1000,
Biomedical Engineering Co., Ltd. Maglumi 1000 Plus, Maglumi 2000, Maglumi 2000 Plus, Maglumi 4000, Maglumi 4000
No.16, Jinhui Road, Plus).
Pingshan New District, Catalog Number Specification
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Shenzhen, 518122, P.R.China 130219004M 100 tests

Tel: 0086-755-21536601 130619004M 50 tests

Fax:0086-755-28292740
SUMMARY AND EXPLANATION OF THE TEST
The human immunodeficiency virus (HIV) is a subgroup of retrovirus that causes the
FOR PROFESSIONAL USE ONLY acquired immunodeficiency syndrome (AIDS). HIV is transmitted by sexual contact,
Store at 2-8°C exposure to blood or blood products, and prenatal infection of a fetus or perinatal
infection of a newborn.
Early after infection with HIV, but prior to seroconversion, HIV antigen(s) may be
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CAUTION: COMPLETELY READ THE detected in serum or plasma specimens. The HIV structural protein most often used as
INSTRUCTIONS BEFORE PROCEEDING
the marker of antigenemia is the core protein, p24. The viremia of HIV infection is about
one to two weeks, the level of p24 antigen increases significantly in the blood soon after
initial infection, and a peak appears in 20 to 30 days. The level of p24 declines as the
SYMBOLS EXPLANATIONS disease progresses. HIV p24 antigen can also be detectable in the late phase of HIV
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disease (AIDS) as a result of excessive viremia. Therefore, the detection of p24 antigen
MANUFACTURER may shorten the window period, and provide early diagnosis.
HIV-1 is the virus that was initially discovered and is the cause of the majority of HIV
infections globally, and HIV-2 infection is endemic in West Africa. Phylogenetic analysis
classifies HIV-1 into group M, N and O. HIV antigen and antibody test may give the
CONSULT INSTRUCTIONS FOR USE
serological evidence of infection with HIV. Group M viruses have spread throughout the
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world; groups N and O are relatively rare and endemic to west central Africa. The
clinical course of HIV-2 infection is generally characterized by a longer asymptomatic
KIT COMPONENTS stage, lower plasma HIV-2 viral loads, and lower mortality rates compared with HIV-1
infection. However, HIV-1/HIV-2 antibodies can be detected from shortly after the acute
phase to the end stage of AIDS. Therefore, the highly sensitive HIV-1/HIV-2 antibodies
IN VITRO DIAGNOSTIC MEDICAL DEVICE assay is irreplaceable for the serodiagnosis of HIV infection. False negative results may
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be obtained by only testing the antibody during the window period, an interval of three
weeks to six months between the times of HIV infection. The body makes antibodies to
BATCH CODE
try to fight HIV, although the antibodies cannot eradicate the virus. Antibody testing is
often done in two parts. First a sensitive screening test is performed on the blood. If the
screening test is positive, a second test is done to confirm that HIV antibodies are
CATALOGUE NUMBER
present. What is more, repeatedly reactive samples must be confirmed according to
recommended confirmatory tests, including Western Blot, HIV RNA tests and so on.
USE BY
PRINCIPLE OF THE TEST
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Sandwich chemiluminescence immunoassay:

TEMPERATURE LIMITATION The HIV Ab/Ag Combi assay is a two-step immunoassay.
( STORE AT 2-8 °C) Use ABEI to label anti-HIV-1 p24 monoclonal antibodies and the HIV-1/HIV-2
recombinant antigens (HIV-1 envelope protein (gp41 and gp120) and HIV-2 envelope
protein (gp36)); and use another anti-HIV-1 p24 monoclonal antibodies and
SUFFICIENT FOR HIV-1/HIV-2 recombinant antigens (HIV-1 envelope protein (gp41 and gp120) and
HIV-2 envelope protein (gp36)) to coat magnetic microbeads.
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In the first incubation, sample (or calibrator/control, if applicable), the magnetic

microbeads and ABEI labeled anti-HIV-1 p24 monoclonal antibodies are mixed
KEEP AWAY FROM SUNLIGHT
thoroughly and incubated at 37°C. The antibodies to HIV-1 and/or HIV-2 present in
the sample bind to the HIV-1 and HIV-2 recombinant antigens to form a complex, and
the HIV-1 p24 antigen present in the sample bind to the anti-HIV-1 p24 monoclonal
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THIS WAY UP antibodies. After washing, ABEI labeled HIV-1 and HIV-2 recombinant antigens are
added, and bind to the complex. Following another wash cycle, the rest unbound
materials are removed, Starter 1+2 is added to initiate a flash chemiluminescent
reaction. The light signal is measured by a photomultiplier within 3 seconds as RLU
which is proportional to the concentration of HIV-1 p24 antigen and antibodies against
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HIV-1 and/or HIV-2 present in samples.

KIT COMPONENTS
Material Supplies
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Component 100 tests 50 tests

Magnetic Microbeads: coated with anti-HIV-1
p24 monoclonal antibodies and HIV-1/HIV-2
recombinant antigens. containing BSA, 2.5 mL 2.0 mL
0.09%NaN3.

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 Please only refer to the current product lot insert enclosed with the kits package for execution and reporting

Calibrator Low: low concentration of HIV-1 have been tested and may be used with this assay. Other types of blood collection tube
p24 antigen (recombinant), containing BSA, have not been verified.
3.0 mL 2.0 mL
0.09%NaN3. Follow manufacturers’ instructions carefully when using plasma collection containers
and gel separator containers.
Calibrator High: high concentration of HIV-1
Separate serum or plasma by centrifugation after standing whole blood at room
p24 antigen (recombinant), containing BSA, 3.0 mL 2.0 mL
temperature.
0.09%NaN3.
ABEI-1 Label: anti-HIV-1 p24 monoclonal
Specimen Conditions
antibodies labeled with ABEI, containing BSA, 17.5 mL 10.0 mL  Do not use specimens with the following conditions:
0.09%NaN3.
(a) heat-inactivated specimens;
ABEI-2 Label: HIV-1 and HIV-2 recombinant
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(b) Cadaver specimens;
antigens labeled with ABEI, bovine serum, 22.5 mL 12.5 mL (c) Obvious microbial contamination.
0.09% NaN3.
 Use caution when handling patient specimens to prevent cross contamination.
All reagents are provided ready-to-use.
Use of disposable pipettes or pipette tips is recommended.
 Inspect all samples for bubbles. Remove bubbles with an applicator stick prior to

Reagent Vials in kit box analysis. Use a new applicator stick for each sample to prevent cross
Internal Quality Control: contamination.
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Negative Control: containing BSA, 0.09%NaN3. 2.0 mL  Serum specimens should be free of fibrin, red blood cells or other particulate

Positive Control 1: Anti-HIV-1 positive, containing BSA, matter.

2.0 mL  Ensure that complete clot formation in serum specimens has taken place prior to
0.09%NaN3.
Positive Control 2: Anti-HIV-2 positive, containing BSA, centrifugation. Some specimens, especially those from patients receiving
2.0 mL anticoagulant or thrombolytic therapy, may exhibit increased clotting time. If the
0.09%NaN3.
Positive Control 3: HIV-1 p24 antigen (recombinant), specimen is centrifuged before a complete clotting, the presence of fibrin may
2.0 mL cause erroneous results.
containing BSA, 0.09%NaN3.
Internal quality control is only applicable with MAGLUMI system. For instructions for
Preparation for Analysis.
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use and target value refer to Quality Control Information data sheet. User needs to
 Specimens must be mixed thoroughly after thawing by low speed vortexing or by
judge results with their own standards and knowledge.
gently inverting, and centrifuged prior to use to remove red blood cells or
particulate matter to ensure consistency in the results. Multiple freeze-thaw cycles
Accessories Required But Not Provided
of specimens should be avoided.
MAGLUMI Series:
 All samples (patient specimens or controls) should be tested within 3 hours of
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Reaction Module REF: 630003 being placed on board the MAGLUMI System. Refer to the SNIBE service for a
more detailed discussion of onboard sample storage constraints.
Starter 1+2 REF: 130299004M  To ensure consistency in results, specimens must be transferred to a centrifuge

tube and centrifuged at ≥1,000 RCF (Relative Centrifugal Force) for 15 minutes
Wash Concentrate REF: 130299005M
before testing if they contain fibrin, red blood cells, or other particulate matter, or
Light Check REF: 130299006M they were frozen and thawed.
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Please order accessories from Shenzhen New Industries Biomedical Engineering Co.,
Storage
Ltd (SNIBE) or our representative.
 Samples can be stored for 24 hours at 2 °C ~ 8 °C, and for 90 days or less at

-20 °C. Avoid repeated freezing and thawing. Stored samples should be
thoroughly mixed prior to use (Vortex mixer).
 Please ask local representative of SNIBE for more details if you have any doubt.
Preparation of the Reagent Integral
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Mix contents of new (unopened) reagent packs by gently inverting pack Shipping
several times. Resuspension of the microbeads takes place Before shipping specimens, it is recommended that specimens be removed from the
automatically prior to use. Visually verify that the microbeads are serum separator, red blood cells or clot. When shipped, specimens must be packaged
completely resuspended in brown color. In case microbeads are not and labeled in compliance with applicable state, federal and international regulations
resuspended, it is recommended to perform a gentle horizontal motion covering the transport of clinical specimens and infectious substances. Specimens
must be shipped frozen (dry ice).
until the microbeads are completely resuspended.
Do not interchange integral components from different reagents or lots!
WARNING AND PRECAUTIONS FOR USERS
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Storage and Stability

 .
 Sealed: Stored at 2-8°C until the expiration date.
 For use in IN-VITRO diagnostic procedures only.
 Opened at 2-8°C: Minimum stability is 4 weeks.
 Package insert instructions must be carefully followed. Reliability of assay results
 On-board: Minimum stability is 4 weeks.
cannot be guaranteed if there are any deviations from the instructions in this
 To ensure the best kit performance, it is recommended to place opened kits in the
package insert.
refrigerator after the end of the intraday test work. It is still possible to keep on
using the kit beyond the opened or on-board period if the controls are found within Safety Precautions
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the expected ranges. CAUTION: This product requires the handling of human specimens.
 Keep upright for storage to facilitate later proper resuspension of microbeads.
 All samples, biological reagents and materials used in the assay must be
 Keep away from sunlight.
considered potentially able to transmit infectious agents. They should therefore be
disposed of in accordance with the prevailing regulations and guidelines of the
CALIBRATION AND TRACEABILITY agencies holding jurisdiction over the laboratory, and the regulations of each
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1) 2-Point Recalibration country. Disposable materials must be incinerated; liquid waste must be
Via the measurement of calibrators, the predefined master curve is adjusted decontaminated with sodium hypochlorite at a final concentration of 5% for at least
(recalibrated) to a new, instrument-specific measurement level with each calibration. half an hour. Any materials to be reused must be autoclaved using an overkill
approach. A minimum of one hour at 121°C is usually considered adequate,
2) Frequency of Recalibration
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though the users must check the effectiveness of their decontamination cycle by
 After each exchange of lots (Reagent Integral or Starter Reagents).
initially validating it and routinely using biological indicators.
 Every 2 weeks and/or each time a new Integral is used  It is recommended that all human sourced materials be considered potentially
(recommended). infectious and handled in accordance with the 29 CFR. 1910.1030 Occupational
 After each servicing of MAGLUMI series Fully-auto chemiluminescence exposure to bloodborne pathogens. Biosafety Level 2 or other appropriate
immunoassay (CLIA) analyzer. biosafety practices should be used for materials that contain or are suspected of
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 If controls are beyond the expected range.

containing infectious agents.
 Whenever room temperature changes exceed 5 °C (recommended).
 This product contains Sodium Azide; this material and its container must be

disposed of in a safe way.

SPECIMEN COLLECTION AND PREPARATION  Safety data sheets are available on request.
Sample material: serum and plasma may be used (including serum collected in serum
separator tubes). The anticoagulants, potassium EDTA, lithium and sodium heparin

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 Please only refer to the current product lot insert enclosed with the kits package for execution and reporting

Handling Precautions history, and other laboratory results. All initially reactive should be redetermined in
 Do not use reagent kits beyond the expiration date. duplicate with the HIV Ab/Ag Combi. If the concentration values <1.0 AU/mL are found
 Do not mix reagents from different reagent kits. in both cases, the samples are considered negative for antibodies and p24 antigen
 Prior to loading the Reagent Kit on the system for the first time, the microbeads against HIV. And repeatedly reactive samples must be confirmed according to
requires mixing to re-suspend microbeads that have settled during shipment. recommended confirmatory algorithms.
 For microbeads mixing instructions, refer to the KIT COMPONENTS, Preparation

of the Reagent Integral section of this package insert. PERFORMANCE CHARACTERISTICS

 To avoid contamination, wear clean gloves when operating with a reagent kit and 1) Precision
sample. Precision for the HIV Ab/Ag Combi assay was determined as described in the CLSI
 Pay attention to the residual liquids which has dried on the kit surface. EP5-A2, low and high positive samples and controls containing different concentration
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 For detailed handling precautions during system operation, refer to the SNIBE of analyte were assayed in duplicate of two at two independent runs per day for 20
service information. testing days on MAGLUMI series Fully-auto chemiluminescence immunoassay
analyzer. The results are summarized in the following table:
TEST PROCEDURE
Mean Within-Run Between-Run Total
To ensure proper test performance, strictly adhere to the operating instructions of Sample
MAGLUMI series Fully-auto chemiluminescence immunoassay (CLIA) analyzer. Each (N=80) SD %CV SD %CV SD %CV
test parameter is identified via a RFID tag on the Reagent Integral. For further anti-HIV-1 (Low
2.991 0.16 5.35 0.05 1.67 0.16 5.35
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information please refer to the operating instructions of MAGLUMI series Fully-auto Positive)

chemiluminescence immunoassay analyzer. anti-HIV-2

(Low Positive) 2.004 0.08 3.99 0.03 1.50 0.09 4.49
+200 μL Sample, calibrator or controls
HIV-1 p24 Ag (Low
+150 μL ABEI-1 Label Positive) 2.099 0.11 5.24 0.06 2.86 0.13 6.19
+20 μL Magnetic microbeads anti-HIV-1 (High
98.258 2.6 2.65 1.75 1.78 3.14 3.20
Positive)
25 min Incubation
anti-HIV-2(High
400 μL Wash cycle Positive) 28.326 1.4 4.94 0.82 2.89 1.65 5.83
+200 μL ABEI-2 Label HIV-1 p24 Ag (High
41.685 1.02 2.45 0.12 0.29 1.03 2.47
Positive)
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15 min Incubation
400 μL Wash cycle anti-HIV-1 (Control) 48.348 1.72 3.56 0.91 1.88 1.95 4.03
3s Measurement anti-HIV-2 (Control) 9.496 0.34 3.58 0.52 5.48 0.62 6.53
HIV-1 p24 Ag
DILUTION (Control) 20.916 0.61 2.92 0.19 0.91 0.64 3.06
Sample dilution by analyzer is not available in this reagent kit.
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Negative Control 0.525 0.26 NA 0.12 NA 0.29 NA

Samples with concentrations above the measuring range can be diluted manually. After
Note: NA = Not Applicable
manual dilution, multiply the result by the dilution factor.
Please choose applicable diluents or ask SNIBE for advice before manual dilution must
2) Analytical Specificity
be processed.
The HIV Ab/Ag Combi assay was evaluated for potential cross-reactivity with other viral
infections and disease state specimens. The results are shown in the table below:
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QUALITY CONTROL
 Observe quality control guidelines for medical laboratories.
Number of Number of the HIV
Clinical Category expected negative Ab/Ag Combi
 Use suitable controls for in-house quality control. Controls should be run at least
samples positive result
once every 24 hours (a run cannot exceed 24 hours), once per reagent kit and
Hemolysis 12 0
after every calibration. The control intervals should be adapted to each
Lipemia 7 0
laboratory’s individual requirements. Values obtained should fall within the defined
ranges. Each laboratory should establish guidelines for corrective measures to be Icterus 10 0
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taken if values fall outside the range. Rheumatoid factor 14 0

ANA 9 0
LIMITATIONS OF THE PROCEDURE
CMV 11 0
1) Limitations
HTLV-1/2 5 0
Assay results should be utilized in conjunction with other clinical and laboratory data to
assist the clinician in making individual patient management decisions. SLE 8 0
A skillful operation and strict adherence to the instructions are necessary to obtain IAV 1 0
reliable results. EBV 8 0
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Procedural directions must be followed exactly and careful operation must be used to
HAV 6 0
obtain valid results. Any modification of the procedure is likely to alter the results.
Bacterial contamination of samples or repeated freeze-thaw cycles may affect the test HBV 20 0
results. HCV 7 0
Pregnant 37 0
2) Endogenous Interference
Total 155 0
The assay is unaffected by Bilirubin<30 mg/dL, Hemoglobin<500 mg/dL or
Triglycerides <2000 mg/dL.
3) Sensitivity
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Seroconversion sensitivity of the HIV Ab/Ag Combi assay has been evaluated by testing
3) HAMA
20 commercial seroconversion panels, which have been tested by commercially available
Patient samples containing human anti-mouse antibodies (HAMA) may give falsely
HIV Ab/Ag Combi assays. The HIV Ab/Ag Combi assa showed equivalent performance
elevated or decreased values. Although HAMA-neutralizing agents are added,
when compared to the results from other commercially available test.
extremely high HAMA concentrations may occasionally influence results.
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4) Clinical Sensitivity
RESULTS
The resulting sensitivity of confirmed positive samples is 100%. The data from this study
1) Calculation of Results
are summarized in the following table.
The analyzer automatically calculates the concentration of antibodies to HIV-1 and/or
Confirmed
HIV-2 in each sample by means of a calibration curve which is generated by a 2-point Specimen Type N Reactive %Sensitivity
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reactive
calibration master curve procedure. For further information please refer to the operating
Clinical HIV
instructions of MAGLUMI series Fully-auto chemiluminescence immunoassay (CLIA) 477 477 477 100.00
positive samples
analyzer. Seroconversion
48 48 48 100.00
samples
2) Interpretation of Results Genotype
76 76 76 100.00
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Results obtained with the HIV Ab/Ag Combi assay can be interpreted as follows: samples
 Non-reactive: A result less than 1.0 AU/mL (<1.0 AU/mL) is considered to be Total 601 601 601 100.00
negative.
 Reactive: A result greater than or equal to 1.0 AU/mL (≥1.0 AU/mL) is considered to
5) Clinical specificity
be positive.
In a group of randomly selected blood donors, hospitalized patients and pregnant women,
Assay results should be interpreted in conjunction with the patient’s clinical presentation,
the specificity of the HIV Ab/Ag Combi assay was found to be greater than 99.5% (RR).

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Specimen Confirmed
N Non-Reactive %Specificity
Type NonReactive
Clinical negative
699 699 699 100.00
samples
HTLV samples 5 5 5 100.00
Seroconversion
96 96 96 100.00
samples
Total 800 800 800 100.00
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REFERENCES
1. Matheron S, Pueyo S, Damond F, et al. Factors associated with clinical
progression in HIV-2 infected-patients: the French ANRS cohort[J]. Aids, 2003,
17(18): 2593-2601.
2. Brust S, Duttmann H, Feldner J, et al. Shortening of the diagnostic window with a
new combined HIV p24 antigen and anti-HIV-1/2/O screening test[J]. Journal of
virological methods, 2000, 90(2): 153-165.
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3. Andersson S, Norrgren H, da Silva Z, et al. Plasma viral load in HIV-1 and HIV-2
singly and dually infected individuals in Guinea-Bissau, West Africa: significantly
lower plasma virus set point in HIV-2 infection than in HIV-1 infection[J]. Archives
of internal medicine, 2000, 160(21): 3286-3293.
4. Meier T, Knoll E, Henkes M, et al. Evidence for a diagnostic window in fourth
generation assays for HIV[J]. Journal of clinical virology, 2001, 23(1): 113-116.
5. Beelaert G, Fransen K. Evaluation of a rapid and simple fourth-generation HIV
screening assay for qualitative detection of HIV p24 antigen and/or antibodies to
HIV-1 and HIV-2[J]. Journal of virological methods, 2010, 168(1): 218-222.
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6. Constantine N T, Zink H. HIV testing technologies after two decades of

evolution[J]. Indian J Med Res, 2005, 121(4): 519-38.
7. Ly T D, Martin L, Daghfal D, et al. Seven human immunodeficiency virus (HIV)
antigen-antibody combination assays: evaluation of HIV seroconversion sensitivity
and subtype detection[J]. Journal of clinical microbiology, 2001, 39(9): 3122-3128.
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8. Branson B M, Handsfield H H, Lampe M A, et al. Revised recommendations for

HIV testing of adults, adolescents, and pregnant women in health-care settings[J].
MMWR. Recommendations and reports: Morbidity and mortality weekly report.
Recommendations and reports/Centers for Disease Control, 2006, 55(RR-14):
1-17; quiz CE1-4.
9. Constantine N T, Zink H. HIV testing technologies after two decades of
en

evolution[J]. Indian J Med Res, 2005, 121(4): 519-38.

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