FDA approves new over-the-counter HIV testing kit for home use

On July, 03, the Food and Drug Administration approved an HIV testing kit for use at home. The kit, manufactured by OraSure, already had preliminary approval for use at a variety of clinics. Called OraQuick, the in-home testing kit will be available in markets and drug stores in October, allowing individuals to test in privacy and get the results in approximately 30 minutes. The FDA is hopeful that the new test kits will reach people who have avoided getting tested, which could lead to both early treatment and a reduction in the transmission rate of the virus.

The test works by the detection of antibodies, obtained from a swabbing sample that is taken from the gums. The FDA said that the test results could not be considered final, as it has returned false positive results in 1 out of every 5,000 cases. They urge anyone using the test to follow up with their doctor or other medical provider. Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said, ” The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”