FDA approves at-home HIV test, available in Oct.

Jul 6 2012

The FDA has approved an at-home HIV test that gives results in under 40 minutes. The tests should be available in stores in October.

The New York Times: Rapid H.I.V. Home Test Wins Federal Approval
After decades of controversy, the Food and Drug Administration approved a new H.I.V. test on Tuesday that for the first time makes it possible for Americans to learn in the privacy of their homes whether they are infected (McNeil, 7/3).

Los Angeles Times: FDA Approves New Home-Use HIV Test
The test, manufactured by OraSure, already had been approved for medical clinics. The new at-home test, called OraQuick, will be sold in supermarkets and pharmacies beginning in October (Duncan, 7/4).

The Wall Street Journal: FDA Approves OraSure's Home HIV Test
The Food and Drug Administration Tuesday approved a home HIV test that will be sold in retail stores so people wouldn't have to go to a health facility to learn if they have the virus. The test, made by OraSure Technologies Inc., has been available to health-care professionals. The test, called the OraQuick In-Home HIV test, uses a mouth swab to collect saliva. The swab is then inserted into a test tube where results are made available within a 20 to 40 minutes (Corbett Dooren, 7/3).

NPR: New Home Test For HIV May Cut Down New Infections
No infectious disease has ever been detectable by a test that consumers can buy over the counter and get quick results at home. But HIV isn't just any infection. It's a stubborn pandemic virus that's still making people sick and killing them 31 years after it first appeared -- even though infection is easily prevented and effectively treated. The Food and Drug Administration's approval of the OraQuick In-Home HIV Test carries the hope that it can help identify some of the nearly quarter-million Americans infected by HIV who don't know it (Knox, 7/3).

Medscape: FDA Approves First At-Home HIV Test
The FDA has approved the first at-home, over-the-counter HIV test, which could potentially inform thousands of Americans about their HIV status. The OraQuick In-Home HIV Test can detect antibodies of the virus from a saliva sample. It can provide results without a laboratory in 20 to 40 minutes (Vashi, 7/3).

Marketplace: FDA Approves At-Home HIV Test
So soon, consumers are gonna be able to go to the drug store, buy an HIV test kit and get their results in private -- all in less than an hour. Marketplace's Adriene Hill reports on the pros and cons of a product that many couldn't have imagined back in the 80s, when the AIDS epidemic was at its height (Hill 7/4).

CNN: FDA Approves First At Home Rapid HIV Test
Much like a pregnancy test, one line shows up if the test is negative, two lines means a positive test. Test results take about 20 minutes. A positive reading does not mean a definite human immunodeficiency virus, but that additional testing should be scheduled with a health professional. However, the FDA also cautions that a negative test result "does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months" (Young, 7/3).