FDA Approves First Ever HIV Home Test

Last week, the FDA approved OraQuick, the first ever fully-private, over-the-counter HIV test. The test, which relies on a mouth swab and delivers results in 20-40 minutes, should be available in some 30,000 stores by October, according to an executive at OraSure, the company that manufactures OraQuick.

The widespread availability of such a test is obviously great news. The Times notes that the chances of an HIV-positive person spreading the disease is up to 96% lower if they're on anti-viral medication, and, according to the Center for Disease Control and Prevention, 20 percent of the 1.2 million Americans infected with HIV don't know they have it, with some 50,000 new infections occur each year. OraSure will also host a "24-hour question line, and advertise to high-risk groups, including gay men, blacks and Hispanics."

Dr. Anthony S. Fauci, the longtime AIDS researcher and director of the National Institute of Allergy and Infectious Diseases, called the new test a "positive step forward" and one that could help bring the 30-year-old epidemic under control.

Dr. Robert Gallo, who headed the National Institutes of Health lab that developed the first American blood test for the virus in 1984, called the F.D.A. approval "wonderful because it will get more people into care."

The test is not perfect. Due in some part to user error, it's 99.98% accurate when the user does not have HIV but only 92% accurate when it comes to positive tests. As the Times points out commenter Brinmat corrected, "only about one person in 5,000 would get a false negative positive test" while "about one person in 12 could get a false positive negative." The FDA noted that any positive test should be followed-up with a test at a doctor's office.

And, of course, there's some trifling bullshit about age restrictions. The FDA only approved use those 17 and older, so anyone youngish looking will probably have to show ID, which puts a damper on some of the privacy benefits and might scare off teenagers. Still, though, OraQuick is major progress.