The LIAAC Blog

News and thoughts from the Long Island Association for AIDS Care

FDA Approves Over-The-Counter Oral HIV Test

By Dr. Gail Barouh

The FDA has recently approved the first over-the-counter oral HIV test. (Other tests have been approved but require a blood sample that had to be sent to a laboratory.) The OraQuick test from Orasure will detect the presence of HIV, the virus that causes AIDS in saliva using a mouth swab.  This is the same test that we use at LIAAC and results can be read in 20 or 40 minutes.

In trials conducted by Orasure they found that the test only correctly detected HIV in those carrying the virus 92% of the time. That means the test could miss one person for every 12 HIV-infected people who uses the kit. The test was accurate 99% for showing those that do not have the virus. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99% of the time.  While it’s not clear why the test is less accurate in consumer trials, company representatives said they expect the test’s specificity to drop when used by consumers versus professionals. To summarize, trials concluded that home test users will receive more false negatives or false positives than if the test were done by a professional.

Without the benefits that one on one counseling can offer, I’m very concerned about people who test negative that have practiced, or will continue to practice unsafe sex because they see being negative as  a license to have unsafe sex.

The tests will be available to consumers in October and be sold through retailers like Walgreens, Walmart , CVS and online pharmacies. Although the company has not announced a price for the test yet it said it would “be less than $60.” The company will operate a toll-free call center to provide counseling and medical referrals to test users, the cost of which would be deferred by the cost of the test.

Although having over-the-counter HIV testing will make testing available to more people, LIAAC will continue to offer FREE HIV testing (as well as free testing for Hep C and other STD’s) which makes testing available to everyone. We also cannot stress the value of one on one, in person post-test counseling and referrals. For more information on FREE testing call 1-877-865-4222.

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