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FDA approves first rapid, take home HIV test



Published: Tue, July 3, 2012 @ 1:35 p.m.

WASHINGTON (AP) — The Food and Drug Administration has approved the first over-the-counter HIV test, allowing Americans to test themselves for the virus that causes AIDS in the privacy of their homes.

The OraQuick test from Orasure is designed to detect the presence of HIV using a mouth swab within 20 minutes.

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.

FDA officials said the test is aimed at people who might not otherwise get tested.

"The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research.


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