FDA Approves OTC HIV Test for the First Time

At the beginning of July, the U.S. American Food and Drug Administration announced the approval of the first (over the counter) HIV tests. The OraQuick In-Home HIV Test from the U.S. American company enables the detection of the presence of antibodies and covers HIV type 1 and HIV type 2. To perform the test, an oral fluid sample by swabbing the gums inside the mouth is collected. The results are available after 20 to 40 minutes. It is hoped that these tests will help reaching populations at risk who wouldn't do an HIV screening. The tests aren't 100% reliable. Clinical studies have shown that one false negative result would be expected out of every 12 test results and that one false positive would be expected out of every 5,000 test results. In 2004, this test was approved for use by trained technicians in clinical settings.

The FDA news release can be found here.

Compiled by
Dr Robert Eicher
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)