NYC Stops Use of Rapid Oral HIV Test Due To High False Positive Rate

The always useful Kaiser Daily HIV Reports has an article about the unusually high false positive rate of OraSure's oral rapidHIV tests (OraQuick Advance Rapid HIV 1/2 Antibody Test) used in NYC which has led to their use being discontinued as of May 27, 2008. The NYC Department of Health and Mental Hygiene has switched to OraSure's blood-based rapid HIV test (OraQuick ADVANCE Rapid HIV Test).

From the June 16 Bloomberg article quoted in the Kaiser report:

The rate of false positives from the OraQuick Advance Rapid HIV 1/2 rose as high as 1.1 percent over the past eight months, or more than five times the level claimed in the kit's labeling, city health officials said. While the test meets U.S. standards and remains on the market, New York's sexually transmitted disease clinics stopped using it to screen saliva on May 27, said Susan Blank, director of the city's Bureau of STD control.

The $12 test is the only one cleared in the U.S. to test saliva for signs of HIV. It generated $32.7 million in 2007 sales, or about 40 percent of company revenue, Orasure said in February. The kit has performed better elsewhere, according to company spokesman Ron Ticho, who said Orasure is cooperating with U.S. regulators reviewing the New York results.

Nothing links the false positives to how the clinics have used the test, Blank said in a June 13 e-mail. ``So far, false positives have not been linked to handling, storage conditions, lot numbers, clinic sites and test operators,'' she wrote.