Known as the OraQuick In-Home HIV test, the test was developed by OraSure Technologies, Inc.
“The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods,” the FDA said in a new release.
“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Dr. Karen Midthun, 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.”
The FDA says clinical studies of the test showed a 92 percent sensitivity rate, which means that of every 12 HIV-infected individuals tested with the kit, one negative result could be expected.
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