INTRODUCTION

This test kit is a serological, lateral flow chromatographic immunoassay for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) p24 antigen, human immunodeficiency virus type 1 antibody and type 2 antibody in human whole blood, serum and plasma samples.

INTENDED USE

HIV Antigen/Antibody Rapid Test Kit is a qualitative membrane-based immunoassay for the detection of HIV-1 p24 antigen, HIV type 1 and HIV type 2 antibody in human whole blood, serum and plasma samples. The test card consists of a burgundy- colored pad containing colloidal gold particles coated with anti-HIV-1 p24 antibody, recombinant HIV-1 antigen and recombinant HIV-2 antigen and a nitrocellulose membrane strip containing test lines (Ag/Ab line) and a control line (C). The Ab line is coated with recombinant HIV-1 antigen , recombinant HIV-2 antigen for the detection of HIV type 1 , HIV type 2 antibody and Ag line is coated with monoclonal anti-HIV-1 p24 antibody for the detection of HIV-1 p24 antigen. When an adequate volume of sample is added to the sample well(S) of the test card, the sample migrates by capillary action across the test card and interacts with the immobilized antigen and antibody respectively. If the sample contains HIV type 1 and/or HIV type 2 antibody and/or HIV-1 p24 antigen, a colored line will appear in the Ag or Ab line region. Absence of Ag and Ab line suggests is a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of sample has been applied to enable migration through the test and control lines, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test card.