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
The human immunodeficiency virus (HIV) is the causative agent of
acquired immune deficiency syndrome (AIDS). The general methodof
with HIV is to observe the presence of antibodies to the virus by
an EIA method followed by confirmation with Western Blot.
TheAdvanced 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. Weargloves
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.