Rapid Anti-HIV 1/2 Test
is a rapid visual test
for the qualitative detection of human immunodeficiency virus (HIV)

INTENDED USE

Rapid Anti-HIV 1/2 Test is a rapid visual test for the qualitative detection of antibodies specific to human immunodeficiency virus (HIV) in human blood serum. This is a screening test, and all positives must be confirmed using an alternate test such as Western Blot. The test is intended for healthcare professional use only.

PERFORMANCE CHARATERISTICS

Specificity

Clinical studies were done to evaluate the performance of Rapid Anti-HIV(1&2) Test In USA and Canada. In both studies, 119 confirmed negative serum samples (USA: 63 samples and Canada: 56 samples) were tested by Rapid Anti-HIV(1&2) Test using EIA and Western Blot as reference tests.  Both studies gave 100% specificity for the test. 

 Sensitivity

In both the studies mentioned above, Rapid Anti-HIV(1&2) Test was evaluated with 64 confirmed positive serum samples (32 samples each in USA and Canada). The sensitivity of Rapid Anti-HIV(1&2) Test was found to be 100% relative to consensus with EIA results, supported by Western Blot assay.