On July 3, 2012, the U.S. Food and Drug Administration (FDA) approved the OraQuick In-Home HIV Test, the first over-the-counter self-administered HIV antibody test that can be performed entirely outside a medical setting.
The FDA’s Blood Products Advisory Committee unanimously voted to recommend approval of the test in May. Although the test can sometimes give false-negative or false-positive results, the FDA concluded that the benefits of more people learning their HIV status outweigh the potential drawbacks.
“As HIV medical providers and researchers on the front lines of the HIV pandemic, we strongly support expanded access to HIV testing to improve early detection of HIV infection,” said HIV Medicine Association chair Judith Aberg. “We also urge continued research and education in heavily affected areas and with low income and minority populations disproportionately affected by HIV to determine how the test instructions and accompanying support materials can raise the accuracy of the test results closer to the level obtained by professionals. Consumer information accompanying this test should also provide clear, ample guidance for people who test positive so they can be linked to confirmatory testing, medical care, and treatment and support services, as well as guidance and resources for those who test negative on how to avoid HIV infection.”