US Health Regulators Approve First At-Home HIV Test

Posted July 3rd, 2012 at 2:10 pm (UTC-5)
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U.S. health regulators have approved the first over-the-counter, self-administered test for HIV, enabling Americans to test themselves for the virus that causes AIDS.

The Food and Drug Administration approved the OraQuick In-Home HIV Test on Tuesday. The test detects HIV in saliva collected using a mouth swab and is designed to deliver results within 20 to 40 minutes.

Manufacturer OraSure Technologies says it plans to make the test available in stores and online starting in October.

U.S. government officials say one in five of the estimated 1.2 million HIV carriers in the U.S. do not know they are infected. The Centers for Disease Control and Prevention says many of the 50,000 new HIV infections each year are transmitted from people who are unaware of their status.

The FDA says the at-home test is aimed at providing another option for individuals to get tested.

But the agency cautioned that the test is not entirely accurate. Clinical studies have shown the home test will only correctly detect HIV in those carrying the virus in 92 percent of cases. The test is said to be more than 99 percent accurate in giving a negative result when a person does not have the virus.