New York City STI Clinics Stop Use of Oral Fluid With HIV Tests Because of Rate of False Positives
June 18, 2008
New York City sexually transmitted infection clinics have stopped using oral fluid with OraSure Technologies' OraQuick Advance Rapid HIV 1/2 Antibody Test because of an increased rate of false positives, Bloomberg reports. According to city health officials, the rate of false positives from the test rose as high as 1.1% -- or about five times higher than the kit's label claims -- over the past eight months (Lauerman, Bloomberg, 6/16). In a statement, the New York City Department of Health and Mental Hygiene said its STI clinics have switched to OraSure's OraQuick ADVANCE Rapid HIV Test that screens blood (Health department release, 6/18).
According to OraSure spokesperson Ron Ticho, the test kit has performed better in other cities. He added that in more than 250,000 tests over the past 17 months at 400 sites in the U.S., the test had a 0.2% false positive rate. "What's happening in New York City appears to be a slight aberration," Ticho said Monday, adding, "Performance results may fall slightly outside the expected range for a short period of time. That's expected." Ticho noted that Orasure is following standard company procedure for investigating product performance and is cooperating with CDC and New York officials to understand the issue.
Bernard Branson, associate director for laboratory diagnostics at CDC's Division of HIV/AIDS Prevention, said the agency is investigating whether health officials in other cities are experiencing similar problems with the oral tests. New York -- as well as health departments in San Francisco, Minnesota and Utah -- recorded similar elevated rates of false positives with the test in 2004 and 2005, according to Bloomberg.
Branson added that Blank has filed a report with CDC and that the agency is considering publishing a notice in its Morbidity and Mortality Weekly Report. "When oral testing showed low numbers of false positives, that reassured everyone," Branson said, adding, "When that changes, people need to find out what the problem is and get to the bottom of it" (Bloomberg, 6/16).
This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.