CAT. NO.

ITP02002
the colloidal gold conjugate is functional.
ADVANCED QUALITY™ Rapid Anti-HIV (1&2) Test REAGENTS AND MATERIALS SUPPLIED
(Whole blood / Serum / Plasma)
FOR IN VITRO DIAGNOSTIC USE • Test cards individually foil pouched with a desiccant.
• Plastic dropper
INTENDED USE
• Sample diluent
THE ADVANCED QUALITY™ RAPID ANTI-HIV(1&2) TEST IS A COLLOIDAL
• Safety lancet
GOLD ENHANCED, RAPID IMMUNOCHROMATOGRAPHIC ASSAY FOR THE
• Alcohol swab
QUALITATIVE DETECTION OF ANTIBODIES TO HUMAN
• Package insert
IMMUNODEFFICIENCY VIRUS (HIV) IN HUMAN WHOLE BLOOD, SERUM OR
PLASMA FROM ALL GROUPS (INCLUDING NEONATES, PREGNANT WOMEN, MATERIALS REQUIRED BUT NOT PROVIDED

ETC). THIS TEST IS A SCREENING TEST, AND ALL POSITIVES MUST BE • Positive and negative controls

CONFIRMED USING AN ALTERNATE TEST SUCH AS WESTERN BLOT. THE STORAGE AND STABILITY
TEST IS INTENDED FOR HEALTHCARE PROFESSIONAL USE ONLY. • The kit must be stored at 2 - 30°C.

SUMMARY WARNINGS AND PRECAUTIONS

The human immunodeficiency virus (HIV) is the causative agent of acquired 1. ALL positive results must be confirmed by an alternative method.
1 2. Treat all specimens as though potentially infectious. Wear gloves and
immune deficiency syndrome (AIDS) . The general method of detecting infection
with HIV is to observe the presence of antibodies to the virus by an EIA method protective clothing when handling specimens.
2 3. Dispose properly after use.
followed by confirmation with Western Blot . The Advanced Quality Rapid Anti-HIV
(1&2) Test is a simple, visual qualitative test that detects antibodies in human 4. Do not use kit materials beyond their expiration dates.
whole blood, serum or plasma. The test is based on immunochromatography and 5. Do not interchange reagents from different lot of kit.
can give a result within 15 minutes. 6. Do not re-use the test strips or any single use accessories.

PRINCIPLE OF THE PROCEDURE ASSAY PROCEDURES FOR FINGER BLOOD

The assay starts with a sample applied to the sample well and add provided 1. Bring the HIV test card, sample diluent, alcohol swab, safety lancet, plastic
sample diluent immediately. The HIV antigen-colloidal gold conjugate embedded dropper.
in the sample pad reacts with the HIV antibody present in whole blood, serum or 2. Remove test card from the sealed pouch.
plasma sample forming conjugate/HIV antibody complex. As the mixture is 3. To perform the HIV test, please follow the steps closely as following (from
allowed to migrate along the test strip, the conjugate/HIV antibody complex is picture 1 to picture 8).
captured by a second antibody immobilized on the membrane forming a colored
test band in the test region. A negative sample does not produce a test band due
to the absence of conjugate/HIV antibody complex. The antigens used in the
conjugate test are recombinant proteins that correspond to highly immunoreactive
regions of HIV1 and HIV2. A colored control band in the control region appears at Bring the safety lancet, Place the activated safety lancet
Clean the finger Pull out the knob
the end of test procedure regardless of test result. The control band indicates that and then twist the knob firmly on the finger. Push the
trigger to prick the finger
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 1. Collect whole blood specimens following regular clinical laboratory
procedures.
2. Heparinized capillary tubes must be used for collecting whole blood samples.
Do not use hemolyzed blood samples.
3. Whole blood specimens should be used immediately after collection.
Draw up blood into Add one drop of blood Add two drops of sample Wait for 15 minutes to Serum or plasma
the plastic dropper to the “S” well diluent to the “D” well interpret the results
1. Collect serum or plasma specimens following regular clinical laboratory
READING THE TEST RESULTS procedures.
1. Positive 2. Only those specimens that are clean, clear and with good fluidity can be used
for the assay.
3. Those specimens that are apparently hemolyzed, extremely thickened or with
very high fat leval are NOT suitable for the assay.
4. Storage: A specimen should be refrigerated if not used the same day of
collection. Specimens should be frozen if not used within 3 days of collecting.
Both purplish test band and purplish control band appear on the membrane. The
lower the antibody concentration, the weaker the test band. Avoid freezing and thawing the specimens more than 2-3 times before use.
2. Negative: 0.1% of sodium azide can be added to specimen as preservative without
affecting the results of the assay.
BEFORE TESTING
1. Bring the test card, sample diluents and specimens to room temperature.
2. Remove test card from the sealed pouch.
ASSAY PROCEDURE FOR WHOLE BLOOD, SERUM OR PLASMA
Only the purplish control band appears on the membrane. The absence of a test
band indicates a negative result. COLLECTED BY REGULAR CLINICAL LABORATORY PROCEDURES
3. Invalid: 1. Dispense 1 drop(10ul) of blood, serum or plasma to the “S” well of the test
card using the plastic dropper provided according to the figure.
2. Then add two drops of sample diluent to the “D” well.
3. Interpret test results at 15 minutes.

There should always be a purplish control band in the control region regardless of
test result. If control band is not seen, the test is considered invalid. Repeat the
test using a new test card.
Whole blood, serum or plasma collected following by regular clinical
Laboratory procedures can also be used for this test.
SAMPLE COLLECTION AND STORAGE
Positive Negative
Negative Invalid
Invalid
Whole Blood One drop of blood ,serum or plasma

2 drops of diluent

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Note: serum/plasma specimens from a variety of medical conditions unrelated to HIV
infection and 114 specimens with interfering substances were analyzed. The
1. It is normal to have a slightly lightened control band with very strong
results of this study are shown in following Table.
positive samples as long as it is distinctly visible.
ADVANCED QUALITY™ RAPID Anti-HIV (1&2)
2. Do not interpret the results after 20 minutes. Medical
POCT RESULTS
3. Applying sufficient amount of samples diluents is essential for a valid test Condition (n=207)
Reactive Non-reactive
result. If migration (the wetting of membrane) is not observed in the test
Multiparous women 0 13
window after one minute, add one more drop of diluents to “D” well.
4. The positive results could appear as soon as 1minute for a sample with Lupus 0 15

high level of HIV antibodies. Rheumatoid factor 1 18

Cytomegalovirus(CMV) 0 15
PERFORMANCE CHARACTERISTICS
Hepatitis A virus (HAV) 2 18
1. Specificity
Hepatitis B virus (HBV) 1 17
Clinical studies were done to evaluate the performance of Advanced Quality
Hepatitis C virus (HCV) 0 15
Rapid Anti-HIV(1&2) Test In USA and Canada. In both studies, 119 confirmed
negative serum samples (USA: 63 samples and Canada: 56 samples) were Syphilis 0 15

tested by Advanced Quality Rapid HIV Test using EIA and Western Blot as Toxoplasmosis 0 15

reference tests. Both studies gave 100% specificity for the test. Tuberculosis 0 15

2. Sensitivity Influenza 0 10

In both the studies mentioned above, Advanced Quality Rapid Anti-HIV (1&2) Multiple transfusions 0 10
Test was evaluated with 64 confirmed positive serum samples (32 samples Cirrhosis 0 13
each in USA and Canada). The sensitivity of Advanced Quality Rapid Colon cancer 0 11
Anti-HIV(1&2) Test was found to be 100% relative to consensus with EIA Chlamydia 0 7
results, supported by Western Blot assay. Interfering Substances ( n=114)

LIMITATIONS Elevated Bilirubin 0 20

1. Only samples that are clear and with good fluidity can be used in this test. Elevated Hemoglobin 0 20
2. Fresh samples are best but refrigerated and frozen samples can also be Elevated Triglycerides 0 20
used after thawing and balancing to the room temperature. If a sample Elevated Protein 0 20
has been frozen, it should be allowed to thaw in a vertical position. Bacterially Contaminated 0 20
3. Do not agitate the sample. Insert a pipette just below the surface of the Visual Hemolytic 0 5
sample to collect the specimen. Icteric 0 5

INTERFERING SUBSTANCES Lipemic 0 4

To assess the impact of unrelated medical conditions or interfering substances on
the specificity of the ADVANCED QUALITY™ Rapid Anti-HIV (1&2) Test. 207

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BIBLIOGRAPHY
1. Blattner, W., Gallo, R.C. and Temin. H.M. HIV causes AIDS. Science. 241:515,
1988.

2. Curran, J.W., Morgan. W.M., Hardy, A.M., et al. The epidemiology of AIDS:
Current status and future prospects. Science 1985; 229:1352:1352-7.

InTec PRODUCTS, INC.

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