Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
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San Francisco Chronicle (11.10.05) - Monday, December 12, 2005
Sabin Russell
CDC plans to advise that clinics immediately follow up positive oral test results by performing a rapid-result blood test, said Dr. Bernard Branson, associate director for laboratory diagnostics at the agency. "What we intend to suggest is that if someone is tested with oral fluid and is positive, that person, if it is possible at the clinic, should get a finger-stick test." The same OraQuick test is licensed to test oral fluid, blood droplets or blood drawn into a test tube. The blood-testing method also delivers results in 20 minutes; however, no comparable reliability issues have been raised for it. If the second test's result is negative, the patient would still need to undergo the more sophisticated Western Blot lab tests. Results for this can take a week, but in the meantime, the patient could be sent home with the assurance that the initial oral test's positive result was likely wrong.
CDC will probably issue the advisory in the next edition of its Morbidity and Mortality Weekly Report, Branson said.
Large-scale monitoring of the test showed an accuracy rate of 99.6 percent, which is comparable to the best blood tests available. But Branson said he is "not comfortable" with the clusters of false positives reported in San Francisco and New York.
Douglas Michels, CEO of test maker Orasure Technologies, said despite the San Francisco false positives, the test's performance has been within guidelines set by the Food and Drug Administration. The agency approved the test for professional use in March 2004 and is considering an application for over-the-counter sales. Michels declined to comment on the reported New York numbers and said he had not discussed with CDC a change in the recommendations for the test's use.
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