FDA Panel Recommends Approval for OraSure’s In-Home Consumer HIV Test, Despite Some Concerns about False Positive Results

Sensitivity and specificity of test kit for over-the-counter sale does not equal that of HIV assays performed in licensed and accredited clinical laboratories

Despite concerns about the potential for false positive results, an in-home rapid HIV test kit designed to be sold to consumers in pharmacies and other retail outlets cleared one more hurdle on the path to winning clearance by the Food and Drug Administration (FDA) to come to market.

On May 15, the 17 voting members of FDA’s Blood Products Advisory Committee (BPAC), concluded that the benefits of the OraQuick in-home HIV test outweigh the potential risks for consumers, according to a story published at cbsnews.com. The FDA advisory panel’s decision came despite earlier reported concerns regarding decreased accuracy of the OTC test when performed by consumers as compared to results from the professional-use version.