FDA Approves First OTC HIV Test Kit

ORA-QUICK In-Home HIV test by OraSure Technologies
ORA-QUICK In-Home HIV test by OraSure Technologies

The FDA approved the OraQuick In-Home HIV Test (manufactured by OraSure Technologies), the first over-the-counter (OTC), self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2).

Individuals 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 20–40 minutes. A positive result 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 result. 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.

Clinical data for self-testing have shown that the OraQuick In-Home HIV Test has an expected performance of 92% for test sensitivity and 99.98% for test specificity. A version of this test for use by trained technicians in clinical settings was approved in 2004.

For more information visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310542.htm?source=govdelivery.