FDA reviews first rapid, take-home test for HIV

The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly test themselves for the virus at home, without medical supervision.

Public health experts estimate one-fifth of all HIV carriers in the U.S., about 240,000 people, are not aware of their status. FDA reviewers said the OraQuick In-Home HIV test could play a significant role in slowing the spread of HIV, according to briefing documents posted today. But they also raised concerns about the test's accuracy.

In a trial by the company OraSure, the test correctly detected HIV in those carrying the virus 93 percent of the time. If the test was approved for U.S. consumers, FDA estimates it would miss about 3,800 HIV-positive people per year.


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