In December 2005, a number of specific sites in San Francisco and New York City, and the L.A. Gay and Lesbian Center reported levels of false positive results while using OraQuick® ADVANCE™ with oral fluid that were higher than expected based on the previously established performance for the product. Immediately after receiving these reports, OraSure Technologies initiated a scientific and systematic evaluation of each situation and has been working in collaboration with affected customers, health care officials and government agencies including the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) to determine the cause or causes for these unexpected results.
(source: orasure.com)
"When the test was approved in 2004, it had a 98.6 percent specificity, which means you could expect about two false positives out of a thousand results," said Richard Klein, a HIV/AIDS program director in the FDA. "Now the results from Los Angeles and San Francisco are showing approximately nine false positives out of a thousand, which the FDA still considers good specificity."
Los Angeles County health officials unveiled a controversial tool last week to fight the spread of HIV and other diseases: a Web site lets people anonymously tell sex partners they may be infected.
The site, inSPOTLA.org, is co-sponsored by the San Francisco AIDS Foundation
Adam will be interviewed on the Derek & Romaine Show on Sirius Radio today. Listen in and let us know what you thought!