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U.S. News

FDA Approves at-Home HIV Test, Available in October

July 5, 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).

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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).

Back to other news for July 2012


This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.



  
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily Health Policy Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
 
See Also
Quiz: Are You at Risk for HIV?
10 Common Fears About HIV Transmission
More on Home HIV Testing

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