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FDA Committee Recommends Approval of First Home HIV Test


A U.S. Food and Drug Administration (FDA) advisory committee this week unanimously recommended approval of the OraQuick In-Home HIV Test. While the test can sometimes give false-negative or false-positive results, the committee decided the benefits of more people learning their HIV status outweigh the potential risks.

The home test -- an over-the-counter (OTC) version of OraSure Technologies' OraQuick ADVANCE Rapid HIV-1/2 test for professional use -- detects antibodies to both HIV-1 and HIV-2 in 20 minutes in samples of oral fluid collected by swabbing the gums. A positive test is indicated by colored lines, somewhat like a home pregnancy test.

The full FDA is not required to follow advisory committee recommendations, but is usually does so. If granted final approval, this will be the first "do-it-yourself" HIV test. A currently available test allows people to take a fluid sample at home and mail it to a laboratory for analysis, with a counselor providing results by phone. The new test provides results directly and can be done entirely without participation of medical professionals or trained counselors.

The cost of the home test has not yet been announced, but OraSure said it would be less than $60.

Members of the Blood Products Advisory Committee expressed concern about inaccurate results that could mislead people into having unsafe sex or deferring treatment, but ultimately the committee voted 17 to 0 that the test was safe and effective, and that the benefits of more people learning their HIV status outweigh the potential risks.

According to clinical trial data described in background material provided ahead of the committee meeting, the in-home test has a sensitivity (ability to identify true-positives) of 92.98% and a specificity (ability to rule out true-negatives) of 99.98%. It is expected to produce 1 false-positive result for every 3750 true-negative results. Specificity was higher, however, when the same test was administered by a professional.

HIV antibody testing is not accurate until the body has had enouh time after exposure to produce antibodies, a so-called "window period" of 2-3 months.

The Centers for Disease Control and Prevention (CDC) estimates that 1 in 5 people with HIV in the U.S. do not know their status. Studies have shown that a large proportion of new infections -- as many as 70% -- are transmitted from people who are unaware they are HIV positive.

OraSure estimated that if 1 million individuals use the new in-home test, 9087 previously undiagnosed HIV positive people would be identified, with the potential to prevent more than 700 onward transmissions annually.

FDA reviewers were more optimistic, projecting that the home test would be used by up to 2.8 million people, leading to 45,000 new diagnoses and potentially preventing as many as 4000 new infections per year.

This assumes, of course, that people who test positive will practice safer sex and enter care, which recent research shows often does not happen.

"There are people who need to get tested who will not do so in a traditional medical setting," the National Association of People With AIDS  (NAPWA) stated in a press release applauding the decision. "We hope many of them take advantage of a home test kit to learn their status, so they can seek treatment for their infections, stay healthy, and take steps not to infect their partners."

"I know from traveling and listening to feedback that many people, including some who have chosen not to know their status using conventional methods, find it intrusive to discuss their sexual history with complete strangers," wrote Tom Donohue, founding director of Who’s Positive, in an op-ed for The Advocate. "An OTC test puts the power in the hands of the person wanting to know their status to decide where they will do this, who they will tell, and how they tell it."

NAPWA urged OraSure and the FDA to provide 24-hour toll-free hotlines for people who need help coping with their test results or finding treatment and support resources.

"We know there are risks in allowing people to test themselves for HIV without counseling, but we also know we are still seeing more than 50,000 new HIV infections every year, and a large majority of them come from sexual contact with people who do not know they have the virus," said NAPWA vice president Stephen Bailous. "Reducing the number of undetected, untreated HIV infections will bring the number of new infections down. In-home testing is one of many new testing and treatment options that promise to bring the end of AIDS in America."

Background material considered by the Blood Products Advisory Committee are available on the FDA website.



U.S. Food and Drug Administration. 2012 Meeting Materials, Blood Products Advisory Committee.FDA web site.

OraSure Technologies. OraQuick In-Home HIV Test Receives Unanimous Positive Recommendation From FDA Advisory Committee. Press release. May 15, 2012.

National Association of People With AIDS. NAPWA salutes FDA Advisory Committee for recommending approval of OTC home HIV test, urges public education about implications of both positive and negative test results. Press release. May 16, 2012.

M Perrone. FDA panel backs first rapid, take home HIV test. Associated Press. May 15, 2012.

T Donohue. Op-ed: The Case for a Rapid Home HIV Test. The Advocate. May 5, 2012.