OraSure Investigates False Positives on HIV Test

Last month, a number of clinics and healthcare centers in the New York, Los Angeles, and San Francisco regions reported a higher-than-expected incidence of false positives on the saliva-based OraQuick Advance HIV test, which is manufactured by OraSure Technologies Inc. (Bethlehem, PA). Although most of the affected centers found only mildly elevated false-positive incidence rates, one San Francisco clinic reported that 25% of the population that tested positive using OraQuick showed no evidence of infection on more-traditional, blood-based follow-up HIV tests.

FDA approved OraQuick for HIV-1 testing in November 2002 and for HIV-2 testing in March 2004. The 20-minute test uses saliva to detect the presence of HIV antibodies. Following FDA's recent announcement that it was considering an HIV test for at-home use, OraQuick was widely believed to be a likely candidate for approval. However, many industry analysts now believe that the reports of false positives will delay expansion of FDA's approval for any HIV test from clinically supervised settings to at-home use.