First rapid DIY HIV test kit sold over the counter gets FDA nod

The U.S. Food and Drug Administration has approved the first over-the-counter, self-administered AIDS test to detect HIV type 1 and type 2 antibodies, according to a company statement. The test could boost the number of people willing to test themselves for HIV and consequently reduce the number of new HIV cases produced because individuals unwittingly transmitted the virus.

It is the first rapid, diagnostic home test approved for an infectious disease, according to a company statement.

The test, developed by OraSure Technologies (NASDAQGS:OSUR) in Bethlehem, Pennsylvania, involves swabbing upper and lower gums and putting the sample in a vial, which produces a result in up to 40 minutes. A statement from the FDA said that users who get a positive result should get additional testing in a medical setting for confirmation. It’s expected to be available in October.

HIV is the virus that causes acquired immune deficiency syndrome or AIDS. About 20 percent of people with HIV don’t know they are infected with the virus, according to a study by the Centers for Diseases Control and Prevention.

The test is modeled after the company’s OraQuick ADVANCE HIV 1/2 Antibody Test, used by hospitals, clinics, community-based organizations and physicians’ offices. That test got FDA approval in 2004.

The in-home HIV test is expected to produce one false positive for every 5,000 test results in uninfected individuals, and one false negative result for every 12 test results in HIV-infected individuals, according to an FDA statement. In May, an FDA advisory panel voted unanimously to recommend approval of the over-the-counter test kit.

About 1.2 million adults and adolescents had HIV in the United States at the end of 2008, according to CDC estimates.

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