FDA Approves Over-the-Counter Rapid-Result HIV Test

The Food and Drug Administration has approved the first over-the-counter rapid-result HIV test, allowing Americans to test themselves for the virus that causes AIDS without needing to send samples to a lab.

In yet another move by governmental agencies to expand options for HIV testing, the FDA has approved an over-the-counter version of the OraQuick rapid-result HIV test for direct sale to the public, despite some potentially alarming issues with the accuracy of the test when performed by untrained testers. USA Today reports:

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…
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 percent accurate.
A trial conducted by [OraQuick producer] Orasure showed the home test only correctly detected HIV in those carrying the virus 92 percent of the time. That means that the test could miss one person for every 12 HIV-infected people who use the kit.
The test was accurate 99 percent 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.
Based in Bethlehem, Pennsylvania, 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 percent 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.

To support consumers, Orasure intends to provide a toll-free call center to provide counseling and medical referrals for users of the at-home OraQuick test. “Each of the call-center operators is bilingual in English and Spanish, they’ve gone through 160 hours of training on HIV counseling and testing,” Orasure CEO Doug Michels told USA Today. “So they are highly trained professionals and they’ll be there to support the consumer.” However, Michels did not address whether Orasure’s call centers would provide partner notification to help test-takers alert their sex or needle-sharing partners of their HIV test results, or if the company would report test results to any other agencies.

Even with these concerns, some researchers are optimistic that the FDA approval will have a positive impact upon the HIV pandemic. Dr. Anthony S. Fauci, the longtime AIDS researcher who heads the National Institute of Allergy and Infectious Diseases, told the New York Times that he considered the FDA’s approval of the over-the-counter OraQuick test a “positive step forward, noting his opinion that “if this enhances the number of people you can get into care, the advantages outweigh any objections.”