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June 18, 2008

NYC Clinics Halt OraQuick Oral HIV Testing

The rate of false HIV-positive results using oral fluid specimens with the OraQuick Advance Rapid HIV 1/2 test in New York City rose as high as 1.1 percent over the past eight months, causing the city’s Bureau of STD Control clinics to suspend saliva-based screening with the assay on May 27, Bloomberg reports (bloomberg.com, 6/16).

According to the article, however, OraQuick has proven successful nationwide, with a 0.2 percent false-positive rate over the past 17 months at 400 testing sites across the country.

“What’s happening in New York City appears to be a slight aberration,” said Ron Ticho, a spokesperson from Orasure Technologies, Inc., which developed, manufactures and markets the rapid test. “Performance results may fall slightly outside the expected range for a short period of time. That’s expected.”

HIV testing sites continue to use OraQuick to screen blood samples, and Bloomberg reports that the test's manufacturer, Orasure, is working with the Centers for Disease Control and Prevention and New York health officials to determine why the rate of false positives in the city is higher than the national average. False-negative aberrations have not been reported.

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JOHN HOPKINS, ATLANTA, GA., 2008-06-19 16:01:38
The false positive increase was something I noted in my district in 2005-2007. I reported this to the company, ORASURE, and they assured me that I was not correct, not that it was to be expected. I did begin to do finger sticks on the positive oral fluid test, but determined that that made no CENTS as I was burning two test and would have to do confimatory testing anyway. So we followed the positive ORAQUICK with the ORASURE test that are sent to the lab for EIA and Western Blot testing.

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