Over-the-counter HIV test awaits approval

WASHINGTON -- The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly check themselves for the virus, without medical supervision.

The OraQuick In-Home HIV test could play a significant role in slowing the spread of HIV, according to briefing documents posted online. But FDA reviewers on Friday also raised concerns about the accuracy of the test, a mouth swab that returns results in about 20 minutes.

The review came one day after an FDA advisory panel endorsed the HIV pill Truvada for preventive use. If the FDA follows the panel's advice, the daily medication would become the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS.

Public health experts estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the country are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.

In a trial conducted by the company OraSure Technologies Inc., the test correctly detected HIV in those carrying the virus 93 percent of the time. That rate is below the FDA-recommended 95 percent threshold. The FDA estimates the test would miss about 3,800 HIV-positive people per year, if approved.

The test was more accurate at correctly clearing patients who do not have the disease. In company studies, OraQuick correctly identified HIV-negative users 99 percent of the time.

On Tuesday, the FDA will ask a panel of outside experts whether the test should be approved for over-the-counter sales. The agency is not required to follow the group's advice, though it usually does.