The FDA on Tuesday approved for the first time for home use an over-the-counter HIV test.
The OraQuick In-Home HIV Test provides results within 20 to 40 minutes. To use, an individual swabs a bit of oral fluid from the gums, places the sample into a developer vial and waits for the results.
"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research. "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."
In clinical studies, the test showed one false positive out of every 50,000 results and one false negative out of every 12 results. The CDC cautioned test takers that if a positive result is obtained, the patient should immediate proceed for an official test in a doctor's office.
According to the CDC, 1.2 million people in the United States are living with an HIV infection, with one in five are not aware they are infected. Doctors hope the test, which will be available in stores by October, will increase awareness about the importance of regular HIV testing.
by RTT Staff Writer
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