NYC Clinics Stop Use Of Oral Fluid With HIV Tests
New York City sexuallytransmitted infection clinics have stopped have stopped using oral fluid with OraSure Technologies' OraQuick Advance Rapid HIV 1/2 Antibody Test because of an increasedrate of false positives, Bloomberg reports. According to city healthofficials, the rate of false positives from the test rose as high as 1.1% -- orabout five times higher than the kit's label claims -- over the past eightmonths (Lauerman, Bloomberg, 6/16). In a statement, the New YorkCity Department of Health and Mental Hygiene said its STI clinics have switchedto OraSure's OraQuick ADVANCE Rapid HIV Test that screens blood (Healthdepartment release, 6/18).
The OraQuick oral test requires users to swab their gums and then place theswab in a holder. After 20 minutes, one line appears on the strip if the testresult is negative and the person is HIV-negative, and two appear if the resultis positive and the person is HIV-positive. Positive results require afollow-up test with a medical professional for confirmation. The test initiallywas provided in the city in response to the number of new AIDS diagnoses amongpeople ages 13 to 26, which increased by 6% in 2006. In addition, aboutone-third of people tested for HIV at public health clinics with other tests donot return for the results, according to CDC (KaiserDaily HIV/AIDS Report, 4/1).
Susan Blank, city commissioner for STI prevention and control, said thatalthough the test meets U.S.standards and is still on the market, the city's 10 STI clinics stopped usingit to screen oral fluid for HIV on May 27. Health officials started noticingproblems in October 2007, and they continued through April, Blank said. Sheadded that although test results returned to normal in May, the city's clinicsstopped using the tests. "So far, false positives have not been linked tohandling, storage conditions, lot numbers, clinic sites and testoperators," Blank said.
According to OraSure spokesperson Ron Ticho, the oral test kit has performedbetter in other cities. He added that in more than 250,000 tests over the past17 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 tobe a slight aberration," Ticho said Monday, adding, "Performanceresults may fall slightly outside the expected range for a short period oftime. That's expected." Ticho noted that Orasure is following standardcompany procedure for investigating product performance and is cooperating withCDC and New Yorkofficials to understand the issue.
Bernard Branson, associate director for laboratory diagnostics at CDC's Division of HIV/AIDS Prevention, said the agency is investigating whetherhealth officials in other cities are experiencing similar problems with theoral tests. New York -- as well as healthdepartments in San Francisco, Minnesotaand Utah --recorded similar elevated rates of false positives with the test in 2004 and2005, according to Bloomberg.
Branson added that Blank has filed a report with CDC and that the agency isconsidering publishing a notice in its Morbidity and Mortality WeeklyReport. "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).
Reprintedwith permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, and sign upfor email delivery at kaisernetwork.org/email . The Kaiser Daily HIV/AIDS Reportis published for kaisernetwork.org, a free service of The Henry J. KaiserFamily Foundation.