FDA Approves Over-the-Counter HIV Test
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OraSure Technologies, Inc./Getty Images(WASHINGTON) — In what could be a breakthrough in preventing the transmission of HIV, the U.S. Food and Drug Administration on Tuesday approved a new over-the-counter test kit called OraQuick that the government says could help identify hundreds of thousands of previously undiagnosed cases of the infection.
“This is the first home-diagnostic HIV test that allows the consumer to obtain a sample by swabbing the upper and lower gum, putting it into a developing vial and waiting for test results to determine – in the privacy of their home – their HIV status,” FDA spokesperson Rita Chappelle said Tuesday.
The test offers a result in approximately 20 to 30 minutes.
There are an estimated 1.2 million people living with HIV in the U.S., and the Centers for Disease Control and Prevention says 1 in 5 cases are undiagnosed.
“This test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by people who typically would not seek out standard screening methods,” Chappelle said.
The test has been more than 99 percent accurate in diagnosing negative results — but one in every 12 tests gave a false positive. Chappelle says consumers should still exercise caution when using OraQuick: infections from within the past three months may not be detected.
“Regardless of the results, they should still follow up in a medical setting to get a confirmatory test.”
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