FDA Approves First Over-the-Counter HIV Test

Nelson Ayala

WASHINGTON — OraQuick, the first over-the-counter HIV test, has been approved by the Food and Drug Administration. Manufactured by Orasure, the test can detect the HIV virus from saliva collected with a mouth swab in 20-to-40 minutes.

FDA officials said that the test will help slow the spread of the HIV virus by providing Americans who would normally not get tested with a private and easy alternative.

"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," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, told the Associated Press.

An Orasure conducted trial showed the home test to be 92% accurate in detecting HIV carriers and 99% in identifying non-carriers. The OraQuick kit, however, has proved to be 99% accurate in recognizing both carriers and non-carriers when administered by health care professionals (Orasure has been providing a version of OraQuick to medical practitioners since 2002).

Orasure will launch the OraQuick test in October, making it available at Walgreens, Walmart, CVS and online pharmacies for an estimated retail price of just under $60. The company said part of OraQuick's cost will go towards setting up a toll-free call center to help answer test users' questions and provide counseling and referrals.