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HIV 1/2 Urine Home Use Test Cassette
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 methodof detecting infection
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 desiccant
• 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 etiologic
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 temperature(18~25℃).
2. Remove test card/test strips from the sealed pouch.
Contact Person: Ms. Anna Lee