SUMMARY

The human immunodeficiency virus (HIV) is the causative agent of acquiredimmune deficiency syndrome (AIDS). The general method of detecting infectionwith HIV is to observe the presence of antibodies to the virus by an EIA methodfollowed by confirmation with Western Blot. The Advanced Quality Rapid Anti-HIV(1&2) Test is a simple, visual qualitative test that detects antibodies in humanurine. The test is based on immunochromatography and can give a result within15 minutes.

PRINCIPLE OF THE PROCEDURE

The assay starts with a diluent prepared sample applied to the sample well. TheHIV antigen -colloidal gold conjugate embedded in the sample pad reacts with theHIV antibody present in urine sample forming conjugate-HIV antibody complex.As the mixture is allowed to migrate along the test strip, the conjugate-HIVantibody complex is captured by a second antibody immobilized on themembrane forming a colored test band in the test region. A negative sampledoes not produce a test band due to the absence of conjugate/HIV antibodycomplex. The antigens used in the conjugate test are recombinant proteins thatcorrespond to highly immunoreactive regions of HIV1 and HIV2. A coloredcontrol band in the control region appears at the end of test procedure regardlessof test result. The control band indicates that the colloidal gold onjugate isfunctional.

REAGENTS AND MATERIALS SUPPLIED

STORAGE AND STABILITY

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 andprotective 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.