A 10-minute, US Food and Drug Administration-approved HIV test

Abstract

It is now an established fact that rapid HIV tests have important applications in a number of testing situations. Currently, four rapid HIV assays have been approved by the US Food and Drug Administration, including the one discussed in this review. A rapid, lateral flow HIV assay was evaluated at the University of Maryland, USA, one of several sites involved in the clinical evaluation. Samples used in the evaluation totaled 9000 and consisted of serum, plasma and venous whole-blood sets of samples from 3000 study subjects that included population groups considered to be at high risk for HIV infection (n=1000), from HIV-positive individuals (n=1000), and from population groups considered at low risk for HIV infection (n=1000). US Food and Drug Administration-licensed screening and confirmatory assays were used as reference tests. The rapid assay exhibited a sensitivity of 100% across all three sample media and exhibited a specificity of 99.8% using whole blood and plasma and 99.7% using serum. This rapid assay is an excellent addition to the existing US Food and Drug Administration-approved rapid HIV tests, and provides versatility by allowing the testing of venipuncture and fingerstick whole-blood samples in addition to serum and plasma.