Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
Reuters NewMedia - December 20, 2005
OraSure, whose share rose 7 percent, said it has begun working with affected customers, health officials and government agencies. Those included the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration.
OraSure said it was reacting to recent reports that specific clinical sites in San Francisco and New York City and the Los Angeles Gay and Lesbian Center have experienced an increased level of false positive results using the OraQuick Advance rapid HIV test.
On Friday, the Los Angeles center halted use of the test after 13 people who took the test in November reported false positive results.
Based on its investigation so far, OraSure said the majority of sites within the affected regions, as well as many other regions throughout the country, have reported rates of false positives that are within the label claims for the test.
The company said it is focusing on specific factors within clinics that may be contributing to unexpected results.
OraSure said it has contacted hundreds of customers and said it will continue to closely monitor test performance throughout the country.
The OraQuick oral test screens for the HIV antibody using saliva and provides a result in about 20 minutes, compared with a seven-day waiting period for traditional HIV tests.
Shares of OraSure rose 58 cents to $8.53 in Tuseday morning trade on Nasdaq, after falling 26 percent on Friday.
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