Anti-HIV Rapid test is for the qualitative determination of antibodies to HIV type 1 and/or 2(HIV1/2) in human serum or plasma

INTENDED USE

The HIV Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of antibodies to human immunodeficiency virus (HIV) type 1 and/or 2(HIV1/2) in human serum or plasma. It is intended for the screening of blood donors and for aid in the diagnosis of clinical conditions related to infection with HIV-1 and/or HIV-2.Performance characteristics Sensitivity The following results were obtained on testing the performance of the HIV (1&2) ELISA Test Kit:Samples Number tested Number positiveAnti-HIV positive 466 466Specificity The specificity of the HIV(1&2) ELISA Test Kit was investigated in an independent laboratory of 9805 serum samples from healthy blood donors tested, 19 samples were found be reactive(99.8%).In this study the specificity obtained was 99.8%.