CDC To Issue Guidelines on Oral HIV Test

CDC plans to issue new guidelines on the use of OraQuick Advance oral HIV tests after a number of false positives recently were reported at clinics in San Francisco and New York City, the San Francisco Chronicle reports. The guidelines likely will be published in next week's Morbidity and Mortality Weekly Report.

Bernard Branson, associate director for Laboratory Diagnostics at CDC, said, "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, manufactured by OraSure Technologies, can test HIV antibodies by using blood from a finger stick, and that method has not had comparable issues with false positives, according to the Chronicle. Results also will have to be confirmed by a traditional blood test that takes about a week to process (Russell, San Francisco Chronicle, 12/10).

According to the San Francisco Department of Public Health, 14 public health clinics in the city in 2005 reported that 49 HIV-positive results from 9,400 OraQuick oral tests were later determined to be false positives.

Deanna Sykes, a researcher at the Office of AIDS, said the tests in San Francisco were determined to be properly administered and the number of false positives "might have something to do with the population they're testing" because some medical conditions produce antibodies similar to HIV (Vesely, Oakland Tribune, 12/10).

Teri Dowling, manager of HIV counseling and testing for the San Francisco Department of Public Health, said officials in New York City told her that clinics there have experienced an increase in false positive results.

Clinics in New York City reported 10 false positives in October and 30 false positive results in November (San Francisco Chronicle, 12/10).

Sykes said there also have been reports of false positives in Ohio (Malnic, Los Angeles Times, 12/10).

OraSure CEO Douglas Michels said from Jan. 1 to Nov. 1 this year, doctors and clinics reported 107 "confirmed complaints of false positives" from OraQuick oral tests out of 28,436 tests conducted for a specificity of 99.6%. "That is within FDA's range (of acceptability)," Michels said (Howard Price, Washington Times, 12/10).