The FDA has approved OraSure, the first-ever at-home HIV testing kit. It allows individuals to swab their gums and obtain test results in less than an hour. Still, the FDA notes that regardless of the outcome, the test’s results should not be overly trusted:
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.
In many ways, OraSure presents a catch-22. Because of the privacy and convenience it affords, many more individuals will hopefully use it to test their status. Unfortunately, the technology is not perfect: one out of every 12 tests performed in HIV-infected individuals returned false negative results. A negative OraSure result could create a false sense of security and dissuade people from ever getting a more reliable test that can’t be self-administered.