INTRODUCTION

The HIV 1/2 Antibody Rapid Test Kit is a one step rapid test for the qualitative detection of HIV 1/2 antibodies in human whole blood/serum/plasma at specified cut- off level.

INTENDED USE

HIV 1/2 Antibody Rapid Test Kit is a rapid immunochromatographic test for the visual detection of HIV antibodies in whole blood/serum/plasma samples in the diagnosis of HIV infection. HIV 1/2 Antibody Rapid Test Kit adopts double antigen sandwich method. When specimen is added into the test device, the specimen is absorbed into the device by capillary action, mixes with the antigen-dye conjugate, and flows across the pre- coated membrane, in which HIV 1/2 antigens are coated respectively. When the HIV 1/2 antibody levels are at or above the target cutoff (the detectionlimit of the test), HIV 1/2 antibodies in the specimen binds to the antigen-dye conjugate and are captured by HIV 1 or/and 2 antigens immobilized in the relative site of test region(T) of the device. This produces a colored Test band in the appropriate test region and indicates a positive result. When the HIV 1/2 antibody levels are zero or below the target cut off. There is not a visible colored band in the test region (T) of the device. This indicates a negative result.