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Rapid oral HIV test wins FDA approval


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Mayo Clinic
AIDS (Disease)
Centers for Disease Control & Prevention
Food and Drug Administration (FDA)
OraSure Technologies Incorporated

(CNN) -- The U.S. government approved Friday the first rapid test -- which collects material from a swab from the mouth -- to detect the presence of the virus that causes AIDS.

Food and Drug Administration officials said the test can provide results within 20 minutes by using a swab to collect oral mucosal transudate, or OMT, from the mouth. In the past, rapid HIV tests required blood samples.

"Where the rapid test is available, those tested get their results within minutes," Health and Human Services Secretary Tommy Thompson said in a statement. "This oral test provides another important option for people who might be afraid of a blood test."

Health-care professionals must supervise the oral test, and they are responsible for delivering results to the person undergoing testing. Positive results must be confirmed by another, more specific test before being considered diagnostic.

The test, which is not approved for in-home or direct consumer use, is more than 99 percent accurate, according to the FDA.

The kit, with the trade name OraQuick Rapid HIV-1/2 Antibody Test, was developed by OraSure Technologies Inc. of Bethlehem, Pennsylvania.

The person being tested must place the device's absorbent pad above the teeth and against the outer gum, then swab once around the upper and lower outer gums.

The tester then puts the device into a vial containing a solution, according to the test's maker. The appearance of two reddish lines in a window on the device indicates the presence of HIV-1, the form of the virus that predominates in North America.

An OraSure Technologies spokeswoman said she did not know how much the test would cost. Also, it has not been approved to screen blood donors, she said.

An estimated one-fourth of about 900,000 HIV-infected people in the United States do not know they are infected, according to the Centers for Disease Control and Prevention. About 31 percent who get tested and are positive never receive their results, the CDC said.

CNN producer Brad Wright contributed to this report.

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