THE ONE STEP RAPID ANTI-HIV(1&2) TEST IS A COLLOIDAL GOLD ENHANCED, RAPID IMMUNOCHROMATOGRAPHIC
ASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HUMAN
IMMUNODEFFICIENCY VIRUS (HIV) IN HUMAN URINE. THIS TEST IS A
SCREENING TEST, AND ALL POSITIVES MUST BE CONFIRMED USING AN
ALTERNATE TEST SUCH AS WESTERN BLOT..
The human immunodeficiency virus (HIV) is the causative agent of acquired 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 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 urine. The test is based on immunochromatography and can
give a result within 15 minutes.
PRINCIPLE OF PROCEDURE
The assay starts with a diluent prepared sample applied to the
sample well. The HIV antigen -colloidal gold conjugate embedded in the sample pad
reacts with the HIV antibody present in urine sample forming conjugate-HIV antibody complex. As the mixture is allowed to migrate along the
test strip, the conjugate-HIV antibody complex is 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 the end
of test procedure regardless of test result. The control band
indicates that the colloidal gold conjugate is functional.
REAGENTS AND MATERIALS SUPPLIED
• Test cards / test strips individually foil pouched with a
• Plastic dropper
• Sample Diluent
• Package Insert
MATERIALS REQUIRED BUT NOT PROVIDED
• Positive and negative controls
SPECIMEN COLLECTION AND STORAGE
1. urine may be used in this test.
2. urine specimens should be refrigerated at 2-8°C up to 3 days.
3. Shipped specimens should be packed in compliance with federal
and international regulations covering the transportation of
4. 0.1% sodium azide can be added to the specimen as a preservative
without affecting the results of the assay.
The kit must be stored at 2 - 30°C.
WARNINGS AND PRECAUTIONS
1.ALL positive results must be confirmed by an alternative method.
2.Treat all specimens as though potentially infectious. Wear gloves
and protective clothing when handling specimens.
3.Devices used for testing should be autoclaved before disposal.
4. Do not use kit materials beyond their expiration dates.
5. Do not interchange reagents from different lot of kit.
1. Bring the device/strips, sample diluent, and specimens to room
2. Remove test card/test strips from the sealed pouch.
For test cards:
1. Dispense 1 drop (10 µl) of urine specimen to the circular sample
well of the test card using a pipette accoding to the figure.
2. Add two drops of Sample Diluent to the sample well immediately
after the specimen is added.
3. Interpret test results at 15 minutes.
For test strips:
1. Dispense 1 drop (10 µl) of urine specimen to the upper edge of the
sample pad of the test strip by using a pipette. .
2. Add two drops of Sample Diluent to the lower edge of the sample
pad immediately after the specimen is added.
3. Interpret test results at 15 minute.
1. Applying sufficient amount of sample diluent is essential for a
valid test result. If migration (the wetting of membrane) is not
observed in the test window after one minute, add one more drop of
diluent to sample well.
2. The positive results could appear as soon as 1 minute for a
sample with high levels of HIV antibodies.
3. Do not interpret result after 20 minutes.
INTERPRETATION OF RESULTS
Negative: Only one colored band appears on the control (C) region. No
apparent band on the test (T) region.
Positive : In addition to a pink colored control (C) band, a distinct pink
colored band will also appear in the test (T) region.
Invalid: A total absence of color in both regions is an indication of
procedure error and/or the test reagent has deteriorated.
Note: It is normal to have a slightly lightened control band with very
strong positive samples as long as it is distinctly visible.
1. Only samples that are clear and with good fluidity can be used
in this test.
2. For diagnostic use only.
STORAGE AND STABILITY
The test kit can be stored at room temperature (18 to 30°C) in the
sealed pouch to the date of expiration. The test kit should be kept
away from direct sunlight, moisture and heat.
1. For in vitro diagnostic use only.
2. Do not use test kit beyond expiry date.
3. The test device should not be reused
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