The Food and Drug Administration (FDA) approved the OraQuick In-Home HIV Test Tuesday, the first over-the-counter self-test for the human immunodeficiency virus.
The HIV test kit works by the user obtaining a saliva sample in their mouth from the gumline, then placing the sample in a developer vial. The test results take 20 to 40 minutes.
The Center for Disease Control and Prevention estimated that 1.2 million people living in the U.S. are infected with HIV, and about 1 in 5 don’t know they are infected. This over-the-counter test will make it easier for individuals to test themselves in the anonymity of their own homes.
“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.”
The FDA urges that any person who obtains a positive result should get confirmation from a doctor, and those who have high-risk sex should be tested regularly.
Douglas Michels, OraSure’s chief executive, stated that the test kit would be available in 30,000 pharmacy retailers by October, and the test is only approved to people 17 and older.
The FDA stated on their website that the “OraQuick In-Home HIV Test has an expected performance of 99.98 percent for test specificity,” meaning one false positive may be expected from one out of 5,000 individuals who are uninfected, but one person in 12 could have a false negative.
OraSure Technologies, OraQuick’s manufacturer, will have a 24-hour consumer-support center hotline to help educate users on information about HIV and AIDS, and how to properly use the test kit.