FDA panel backs over-the-counter HIV test kit

Orasure swab HIV oral test

A lot of people fear going to the doctors to get tested for sexual health for various reasons: Shyness, embarrassment, denial, fear that something could actually be wrong with your body. While those feelings are completely natural, that doesn’t make it less important for you to visit the doctors regularly especially if you have an active sex life. But now that the Food and Drug Administration is in talks to approve a 20-minute HIV test kit, you may soon be able to face your fears in the privacy of your own home.

The unanimous vote by the FDA came through on Tuesday, passing the OraQuick HIV test as an acceptable method of a take-home exam for the AIDS virus. The kit utilizes a cotton swab that could produce negative or positive results in just 20 minutes. However, it’s important to note the OraQuick HIV test will not be as accurate as a real blood test at a medical clinic. The kit is much like an over-the-counter pregnancy test that can help get you some quick answers, but a visit to the doctors will always be more thorough.

Although the panel of experts has voted for the OraQuick HIV kit, an official approval is still pending. In a consumer trial, the kit was able to accurately test for those carrying the HIV virus 93 percent of the time. According to the New York Times, this means “the test would miss about 3,800 HIV-positive people per year, while correctly identifying 45,000, if approved for U.S. consumers.” Despite the less than perfect percentage, the panel agreed the benefits far outweigh the disadvantages, as there are no side effects for letting consumers test themselves at home. Previous methods of in-home HIV tests required patients to mail in blood samples as they await results.

“Over-the-counter testing has the potential to reach a far greater number of people who want to know their HIV status on their own terms,” said Tom Donohue, founder of HIV awareness group Who’s Positive.

The United States government estimates that one-fifth, or approximately 240,000 people, of the 1.2 million HIV carriers are not aware they are infected. The over-the-counter kit could help patients get treatment sooner than later, and prevent them from spreading the infection when they realize they carry the virus. Infected patients should also call a toll-free helpline to get medical advice if their tests reveal a positive result. The professional version of the Orasure’s OraQuick HIV test currently sells for $17.50, and there are currently no words on how much the consumer version is expected to cost, if approved.

Image Credit: Flickr / Wheeler Cowperthwaite

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