TUESDAY, July 3 (HealthDay News) -- The first over-the-counter test to detect antibodies to the virus that causes AIDS has been approved by the U.S. Food and Drug Administration, the agency said Tuesday.
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The OraQuick In-Home HIV Test allows anonymous users to swab the upper and lower gums and obtain results within 40 minutes, the FDA said in a news release.
A positive result does not mean the test user is necessarily infected with HIV, but that additional testing should be done by a medical professional, the agency said. Similarly, a negative result does not guarantee that the test user is not infected with HIV, particularly if possible exposure to the virus has come within the prior three months, the FDA warned.
Some 1.2 million people in the United States are infected with HIV, and about one-in-five is not aware that they're infected, the FDA said, citing estimates from the U.S. Centers for Disease Control and Prevention. About 50,000 people are newly infected each year, the FDA said.
The test is produced by OraSure Technologies, based in Bethlehem, Penn. A clinical version of the test for use in professional settings was approved in 2004.
-- Scott Roberts
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