FDA approves OTC HIV test


SILVER SPRING, Md. — The Food and Drug Administration has approved over-the-counter sales of a test for the virus that causes AIDS, the agency said Tuesday.

The FDA announced the approval of the OraQuick In-Home HIV Test, calling it the first OTC, self-administered HIV test kit that detects the presence of antibodies to HIV, including the HIV-1 and HIV-2 strains.

People can use the test to collect an oral fluid sample by swabbing their upper and lower gums and then placing the sample into a developer vial. Test results appear in 20 to 40 minutes. The agency said, however, that a positive test does not necessarily mean a person has become infected; nor does a negative result mean a person is not infected if the infection has occurred within the past three months. According to clinical trials, 99.98% of test results will be negative when HIV is not present, meaning that one false positive would be expected out of every 5,000 test results in uninfected people.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," FDA Center for Biologics Evaluation and Research director Karen Midthun said. "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."

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