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FDA approves first over-the-counter HIV test

The OraQuick test detects the presence of HIV in saliva that is collected using a mouth swab.

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One in about 300 HIV-infected patients have a natural ability to fight off the deadly AIDS virus. (RODGER BOSCH /AFP/Getty Images)

Americans can now test themselves for HIV in the privacy of their homes after the Food and Drug Administration on Tuesday approved the first over-the-counter test for the virus that causes AIDS.

OraQuick detects the presence of HIV in saliva that is collected using a mouth swab. Results can be expected in 20 to 40 minutes, The Associated Press reported.

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Experts stressed that any positive result should be confirmed through additional testing in a medical setting, according to Agence France-Presse.

About 1.2 million people in the US are infected with HIV, and about 50,000 infections are diagnosed each year, although government officials estimate that as many as one-fifth of carriers do not know they are infected, according to the Wall Street Journal.

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Medical officials are hoping to better those numbers with easier -- and more discreet -- testing.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, told the Wall Street Journal. "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."

Based in Bethlehem, Pa., OraSure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2002. When used by professionals, the test is 99 percent accurate, according to the AP.

Trials by OraSure have shown the home version to be about 92 percent accurate.

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