FDA approves first at-home HIV test

July 19, 2012

FDA recently approved the first over-the-counter test for HIV, providing a confidential in-home testing option for the virus that causes AIDS with results in as little as 20 minutes.

FDA recently approved the first over-the-counter test for human immunodeficiency virus (HIV), providing a confidential in-home testing option for the virus that causes acquired immune deficiency syndrome (AIDS), with results in as little as 20 minutes.

“This new in-home rapid test-the same test doctors have used for years-will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting," said Douglas A. Michels, president and CEO of OraSure Technologies, the manufacturer of the OraQuick In-Home HIV Test.

The test is designed to detect the presence of antibodies to HIV-1 and HIV-2 through an oral fluid swab of the upper and lower gums inside the mouth. The fluid sample is then put into a developer vial for 20 to 40 minutes.

According to FDA, The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are living with HIV infection, and about 1 in 5 are not aware that they are infected. This test has the potential to identify large numbers of people with previously undiagnosed HIV infections who might not otherwise use traditional screening methods at clinics and other centers.

FDA stresses that outcomes are not absolute, especially when exposure may have occurred within the past 3 months. Clinical studies have indicated that the home test could result in 1 false negative for every 12 test results and 1 false positive for every 5,000 test results in uninfected individuals.