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FDA Approves HIV Home-Use Test Kit

Hugh Pickens writes "The LA Times reports that the Food and Drug Administration has approved the first over-the-counter HIV test kit, allowing people to test themselves in private at home and get preliminary results in less than 30 minutes. The test, which works by detecting antibodies in a swab from the gums, should not be considered final — in trials, the test failed to detect HIV in 1 in every 12 patients known to be infected, and returned false positives in 1 in 5,000 cases. The new at-home test, called OraQuick, will be sold in supermarkets and pharmacies and manufacturer, OraSure, has not said how much the test will cost, only that it will be more than the $18 cost for the professional kit. The federal Centers for Disease Control and Prevention estimates that of the 1.2 million people in the U.S. with HIV, 1 in 5 is not aware of the infection and that a disproportionate number of the 50,000 new cases of HIV each year is linked to people who have not been tested. Chip Lewis, a spokesman for Whitman-Walker Health, which provides AIDS care in Washington, says at-home testing could reach some people who didn't want to go to a clinic but removing medical professionals from the process could cause problems. 'It's not like a home pregnancy test,' says Lewis. 'You need really a lot of information about how to read the test, how to use the test properly.'" Back in May, we reported that a panel of FDA experts recommended approval of an over-the-counter HIV test.

2 of 186 comments (clear)

  1. Re:This will end badly... by ShanghaiBill · · Score: 5, Insightful

    People (as a group), who have proven themselves to be not the best logicians time and time again, will take this as proof they are in the clear and start spreading it around.

    People who feel they need to use this test are already spreading it around. If this stops 11 of 12, that is a good thing. Just because something isn't perfect, doesn't make it worthless. Life is not black and white.

  2. Re:It's only 92% accurate ... by fuzzyfuzzyfungus · · Score: 5, Insightful

    Eh, this isn't the 1980s anymore. Are hard-partying homosexual intravenous drug users still a high risk demographic? Sure.

    Has AIDS become something of a crossover hit, especially but not exclusively in the developing world, with substantial uptake among behaviorally prosaic demographics? Oh yes, yes it has...

    At the risk of sounding blunt to the point of crassness, if the 'AIDS = Ass Cancer' theory of epidemiology were actually accurate, we wouldn't still be talking about it. It's hard for a virus that has no significant animal vectors and can't survive outside the body worth a damn to hang on if it can only burn its way through crazy-high-risk demographics. There just aren't that many of those, and they tend to die.