Oral HIV testmaker addresses false results
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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."
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."
[Biz] Posted by fergie at December 23, 2005 11:39 AM
