Over-The-Counter, At-Home HIV Test Gets FDA's OK

In another bid to stop the spread of the HIV virus that can lead to AIDS, the Food and Drug Administration announced today that it has approved for sale the first over-the-counter, self-administered HIV test kit that doesn't need to be sent to a laboratory to determine the result.

The OraQuick In-Home HIV Test should be on sale online and at 30,000 retail outlets by this October, according to the test's manufacturer, OraSure Technologies of Bethlehem, Pa.

In the statement announcing the approval, Dr. Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, says that "knowing your status is an important factor in the effort to prevent the spread of HIV. The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

Last month on NPR's Talk of the Nation, Dr. Anthony Fauci, director of the NIH National Institute of Allergy and Infectious Diseases, said "the benefit of making this type of test available far outweigh the risks. If you just look at the numbers ... there are about 1.1 to 1.2 million people infected in this country. Twenty percent of them do not know that they are infected. About 50 to 70 percent of the new infections that occur in this country, occur from people who do not know they are infected infecting their partner. And any way that we can get people tested to be aware of their HIV status I think would be very, very important."

According to The Associated Press, the OraQuick test "is designed to detect the presence of HIV using a mouth swab within 20 minutes. ... The FDA has already approved other HIV test kits designed to be used at home, but those kits must be sent to a laboratory to be developed."

The at-home test, OraSure says, "is an over-the-counter version of the company's OraQuick ADVANCE HIV 1/2 Antibody Test, the market leading rapid HIV test with millions of units sold to hospitals, clinics, community-based organizations and physician offices."

No price for the kit is mentioned in the company's materials.