FDA Approves In-Home HIV Test

The Food and Drug Administration (FDA) has approved the first over-the-counter home use HIV test kit. The OraQuick In-Home HIV Test is a self-administered test to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). A version of the test for use by trained technicians in clinical settings was approved in 2004.

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 placing that sample into a developer vial; test results appear in 20 to 40 minutes. A positive result does not mean that an individual is definitely infected with HIV, but 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. OraSure Technologies, the manufacturer of the OraQuick In-Home HIV Test, said it will have a phone-based consumer support center that will be open 24 hours a day.

Psychiatric News has reported on advice from experts on managing neurocognitive impairment associated with HIV disease. Read about it here.

(Image: Orasure Technologies, Inc.)