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FDA approves first over-the-counter HIV test kit

Photo: FDA

The OraQuick In-Home HIV Test will be available in stores and online (final packaging may be different).

The U.S. Food and Drug Administration announced on Tuesday the approval of the first over-the-counter, self-administered HIV test kit.

The OraQuick test detects the presence of HIV antibodies via a mouth swab, and returns a result in 20 to 40 minutes.

Of the roughly 1.2 million people carrying HIV in the U.S., 240,000 people, or one-fifth, don't know they're infected, says the CDC. 

Notes the FDA:

A positive result with this test does not mean that an inpidual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result.

Similarly, a negative test result does not mean that an inpidual is definitely not infected with HIV, particularly when exposure may have been within the previous three months.

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.

Orasure plans to start selling the test in October online and through retailers like Walgreens, CVS and Walmart.

The consumer version is expected to cost less than $60, but more than the one marketed to health professionals (which costs about $17.50).

The price increase, said Orasure CEO Doug Michels, will help pay for the toll-free call center and training.


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