FDA advisory panel recommends approval of home HIV test.

The AP (5/16, Perrone) reports in a story appearing on over 470 news sites that the Food and Drug Administration Blood Products Advisory Committee in a unanimous 17-0 vote, "recommended approval of the first rapid, over-the-counter HIV test." The committee concluded that "the benefits of the OraQuick HIV test outweigh its potential risks for consumers," chiefly that it "does not appear to be as accurate as professionally-administered diagnostics." The expected benefit from the test is that people who have HIV and have not been tested will be more likely to test themselves, though "the FDA estimated the test would miss about 3,800 HIV-positive people per year, while correctly identifying 45,000, if approved for US consumers."

        The Wall Street Journal (5/16, A6, Dooren, Subscription Publication) reports the panel concluded that the hoped for benefits were greater than the "potential risks of false positive and false negative results." The test works on saliva collected on a swab and inserted into material in a test tube.

        The Washington Post (5/16, Sun) reports the test would offer "an important additional tool for many Americans who are reluctant to get tested." It also notes that "a national poll conducted last spring by the Kaiser Family Foundation found that 44 percent of Americans between ages 18 and 65 said they had never been tested for HIV. Asked to list reasons why they had not been tested, 64 percent said they did not believe they were at risk of contracting HIV, 29 percent said their doctor had never recommended testing and 12 percent said they did not know where to go for testing."

        The Philadelphia Inquirer (5/16, Sapatkin) reports, "The panel overcame considerable unknowns and concerns the test cannot pick up newly acquired infections to focus on a bigger picture."