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FDA approves first over-the-counter home use HIV test kit
Originally printed 7/12/2012 (Issue 2028 - Between The Lines News)
The U.S. Food and Drug Administration announced July 3 it has approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2).
The test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes. A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result.
There are about 50,000 new HIV infections every year. "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."
Clinical studies for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92 percent for test sensitivity, the percentage of results that will be positive when HIV is present. This means that one false negative result would be expected out of every 12 test results in HIV-infected individuals.
Information about the consumer support center and contact information is included in the test kit.
You can learn more by visiting http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/HIVHomeTestKits/ucm126460.htm