WASHINGTON — The Food and Drug Administration approved the first over-the-counter HIV test Tuesday, allowing people to test themselves in private at home and get preliminary results in less than 30 minutes.
“Knowing your status is an important factor in the effort to prevent the spread of HIV,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
The test, manufactured by OraSure, already had been approved for medical clinics. The new at-home test, called OraQuick, will be sold in supermarkets and pharmacies beginning in October.
Full story: FDA approves new home-use HIV test