WASHINGTON, D.C. -- Just a week after Walgreens announced it would provide HIV testing through its pharmacy in select cities, the Food and Drug Administration approved an over-the-counter HIV testing kit, made for at-home use.
The kit, called OraQuick In-Home HIV Test, is the first of its kind. OraQuick detects the presence of antibodies to human immunodeficiency virus type 1 and type 2 by testing a sample of fluid from a consumer's mouth.
OraQuick has been approved for sale in stores and online to anyone age 17 and older.
"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."
Along those lines, patients that receive a negative test result does not necessarily mean they are not infected with HIV, especially in the case that exposure was within the previous three month.
Clinic studies show OraQuick has an expected performance of 92 percent for sensitivity and 99.98 percent for specifying which type of HIV an individual might have.
According to the Centers for Disease Control and Prevention, about 1.2 million people in the U.S. are living with HIV infection, and about 1 in 5 of these people don’t know that they are infected, increasing the chance that they will unknowingly spread the infection.