FDA approves first over-the-counter HIV test kit

SILVER SPRING, MD – The U.S. Food and Drug Administration approved on July 3, the OraQuick In-Home HIV Test. It is the first over-the-counter, self-administered HIV test kit for the detection of antibodies to human immunodeficiency virus type 1 (HIV 1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

The OraQuick In-Home HIV Test is designed for use by collecting an oral fluid sample by swabbing the upper and lower insides of the mouth and then placing the sample into a developer vial. Test results will be obtained within 20 to 40 minutes. A positive result with this test does not mean HIV infection, but rather that additional testing should be done in a medical setting for confirmation.

Similarly, a negative 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 for the identification of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “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.”

Clinical studies for self-testing have shown an expected performance of 92% for test sensitivity (the percentage of results that will be positive when HIV is present). This means that one false negative is expected out of every 12 test results in HIV-infected individuals.

Expected performances of 99.98% for test specificity (the percentage of results that will be negative when HIV is not present) have also been demonstrated during clinical studies. This means that one false positive would be expected out of every 5,000 test results in individuals uninfected with HIV.

OraSure Technologies, the manufacturer of OraQuick In-Home HIV Test will have a consumer support center available via phone 24 hours a day, seven days a week.  The center will be operational and available for education on HIV/AIDS, as well as on the proper method of administering the test and on what to do after obtaining the results.