FDA Recommends Approval Of First Home HIV Test
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WASHINGTON (CBSDC/AP) — A panel of HIV specialists is recommending that U.S. regulators approve the first over-the-counter HIV test designed to quickly return a result in the privacy of a person’s own home, a new option which could expand testing for the virus that causes AIDS.
The 17 members of the Food and Drug Administration advisory panel voted unanimously that the benefits of OraQuick HIV test outweigh its potential risks for consumers. The test kit uses a mouth swab sample to detect the presence of HIV within 20 minutes.
The manufacturer OraSure already sells a version of the test to doctors and other health professionals. Studies showed the test was less accurate when used by consumers, but panelists said that the benefits of expanding HIV testing outweigh a small decrease in test accuracy.
The Centers for Disease Control and Prevention estimates there are 1.2 million people in the United States living with HIV infection. Roughly 20 percent of those infected are unaware they are carrying the virus.
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