FDA Panel Backs First Rapid, Take Home HIV Test
WASHINGTON (AP) - American consumers may soon be able to test themselves for the virus that causes AIDS in the privacy of their own homes, after a panel of experts on Tuesday recommended approval of the first rapid, over-the-counter HIV test.
The 17 members of the Food and Drug Administration advisory panel voted unanimously that the benefits of the OraQuick HIV test outweigh its potential risks for consumers. While the test, which uses a mouth swab to return a result in 20 minutes, does not appear to be as accurate as professionally-administered diagnostics, panelists said it could provide an important way to expand HIV testing.
The FDA will make its final decision on whether to approve the product later this year, weighing the opinion of the panel.
Government officials estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.
Based in Bethlehem, Pa., Orasure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2004. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.
But a trial conducted by the company showed the home test only correctly detected HIV in those carrying the virus 93 percent of the time. The FDA estimated the test would miss about 3,800 HIV-positive people per year, while correctly identifying 45,000, if approved for U.S. consumers. The test could prevent 4,000 new transmissions of the virus annually, though the figure could vary depending on how many people purchase the test. While it’s not clear why the test was less accurate in consumer trials, company researchers said they expected the test’s sensitivity to drop when used by consumers versus professionals.
Panelists stressed that the test’s labeling should state that a negative reading does not automatically mean the person does not have HIV, because of imperfect results. Panelists also stressed the importance of a toll-free number to put those who test positive in touch with counseling and medical care.