INTRODUCTION

 

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..

 

SUMMERY

 

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.

 

PRINCIPLEOF 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