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Know Your Status: Over-The-Counter HIV Test Approved In U.S.
July 4, 2012
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Big health news: the U.S. Food and Drug Administration has approved the first ever over-the-counter HIV test. Why is a home test kit such a big deal? Well, according to U.S. estimates, one-fifth of the 1.2 million HIV carriers in the States don't know they're infected - and in Canada, as many as 26 percent of HIV carriers may be unaware of their status. Being able to test at home could increase detection and reduce the risk of new infections.

The OraQuick test uses saliva collected in a mouth swab to detect HIV. Results take 20 to 40 minutes to appear. But the test isn't perfect: the FDA said in its approval announcement that the home test only correctly detected people carrying the virus 92 percent of the time in a consumer trial conducted by Orasure, the company that makes the kits. That means OraQuick could miss one in 12 people with HIV who use the kit. In terms of false positives, the test is supposed to be 99 percent accurate in ruling out HIV in patients without the virus.

OraQuick is expected to roll out in October at various mainstream retailers across the U.S., as well as online. The cost has not been announced, but Orasure says it will cost less than $60 per kit.

There is no word so far about whether Canada will consider approving this test or something similar. A Canadian government study found that at the end of 2008, 65,000 people in this country were living with HIV infection, up from 57,000 at the end of 2005. And the study estimates that 26 percent of all infected Canadians are unaware that they have the disease, while a full 35 percent of heterosexuals who have HIV don't know they are infected.

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