The OraQuick test detects the presence of HIV in saliva collected using a mouth swab. The test is designed to return a result within 20 to 40 minutes.
Government officials estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.
FDA officials said the test is aimed at people who might not otherwise get tested.
"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," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research.
FDA stressed in its approval announcement that the test is not 100 per cent accurate.
A trial conducted by Orasure showed the home test correctly detected HIV in those carrying the virus only 92 per cent of the time. That means the test could miss one person for every 12 HIV-infected people who use the kit.
The test was accurate 99 per cent in ruling out HIV in patients not carrying the virus. That means the test would incorrectly identify one patient as having HIV for every 5,000 HIV-negative people tested.
The FDA previously approved several HIV test kits designed to be used at home, although those kits — which usually require a blood sample — must be sent to a laboratory to be developed.
Orasure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2002. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 per cent of the time.
While it's not clear why the test appears less accurate in consumer trials, company researchers said they expected the test's specificity to drop when used by consumers versus professionals.
Orasure plans to launch the test in October, selling it through retailers like Walgreens, CVS and Walmart, as well as online pharmacies. Whereas the test marketed to health professionals costs about $17.50, Orasure expects the consumer version to sell for more. The company is not announcing a price yet, but said it would be less than $60. CEO Doug Michels said the additional cost will help pay for a toll-free call centre to provide counselling and medical referrals to test users.
Shares of Orasure Technologies rose 59 cents, or 5 per cent, to $12.09.