Main | Tuesday, July 03, 2012

FDA Approves In-Home HIV Test

Back in May I told you that the FDA was evaluating an in-home HIV test. Today OraSure Technologies received approval to begin selling the test kit to drugstores and online. The FDA announced today's decision with a press release and a warning:
The OraQuick In-Home HIV Test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes. A positive result with this test does not mean that an individual 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 individual 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.
Bolding is mine. Shortly after my first post on this product, I managed to corner an OraSure executive backstage at the NYC AIDS Walk, where I grilled him about the possible abuses of the product by parents and partners and about the potential for self-harm upon a positive result. He told me that the company had considered all of that and had the position that those hopefully rares occurrences were outweighed by the potential for getting many more people on the necessary treatments.

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