First Over-The Counter H.I.V. Test Approved By The FDA


Americans who want to find out in the privacy of their homes whether they are inflicted with H.I.V can now use the FDA-approved OraQuick Test, by OraSure Technologies. The test is conducted by taking a swab of fluid from the gum line in the mouth and the results appear after 40­–50 minutes.

Many believe that this test could be the one that brings the 30-year AIDS epidemic to an end because it should help in reducing the stigma associated with the virus. For years the test was unapproved by the FDA for fear of how Americans would react to finding out they were positive with H.I.V. while at home and without any counseling. According to the New York Times, the CDC even warned the FDA that approving such a test would lead to lines of people at clinics needing treatment.

It is estimated that of the 1.2 million Americans infected, about 20% do not know they are H.I.V. positive. According to the CDC, 50,000 Americans become infected each year.

The test is 99% accurate when administered by a professional to one without H.I.V. However, when administered to someone infected with H.I.V. the accuracy went down to 92%. Additionally, about one person in 5,000 will get a false positive test, and about one person in 12 could get a false negative.

The test will only be available for those 17 and older which may lead to stores asking consumers for their ID. According to OraSure, the test should be available in October at most retail stores, as well as on-line.

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