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| More False-Positive Results with Rapid Oral-Fluid HIV Tests |
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| Posted by Dr. Johanne Perez M.D |
| Wednesday, 09 July 2008 00:00 |
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Recent experience indicates that all reactive oral-fluid tests should be followed by whole-blood tests using finger sticks. Western blot confirmation is required for all positive rapid tests
From November 2007 through April 2008, the number of false-positive results with oral-fluid tests at New York City sexually transmitted disease clinics was much higher than expected, based on the manufacturer’s claims regarding specificity. In late May 2008, the clinics discontinued the use of oral-fluid testing and reinstituted finger-stick whole-blood testing as the initial rapid test for HIV. Comment: Point-of-care rapid HIV testing, whether with whole blood or oral fluid, has dramatically increased the number of people tested each year (by almost twofold in these clinics) and the proportion who receive their results. Although oral-fluid testing is more convenient, the specificity of OraQuick testing is lower with oral-fluid specimens than with whole blood. (Notably, the specificity is still above 98%, the FDA minimum threshold for rapid HIV tests.) The experience in New York City indicates that all reactive oral-fluid tests should be followed by whole-blood tests using finger sticks: If both tests are reactive, the true result is likely positive; if only the oral-fluid test is reactive, the true result is likely negative. In any case, Western blot testing is required to confirm positive results on rapid HIV tests. — Carlos del Rio, MD Published in AIDS Clinical Care July 7, 2008 Citation(s): Centers for Disease Control and Prevention (CDC). False-positive oral fluid rapid HIV tests — New York City, 2005–2008. MMWR Morb Mortal Wkly Rep 2008 Jun 20; 57:660. |
| Last Updated on Wednesday, 13 August 2008 15:10 |
The OraQuick Advance Rapid HIV-1/2 Antibody Test was approved by the FDA in 2002 and can be used to test either oral fluid or blood. In late 2005, counselors at several HIV testing programs in New York City reported an unusually high proportion of false-positive results from the OraQuick oral-fluid test. At the time, CDC investigators found no evidence of lot- or device-related problems and instead pointed to unidentified client- or site-specific factors.