FDAnews Device Daily Bulletin


Dec. 22, 2005

OraSure Technologies is investigating reported problems with the company's HIV test at several testing sites in New York and California. But the firm also said it remains confident in the overall performance of the test.

Clinics in San Francisco and New York City and the L.A. Gay and Lesbian Center have experienced an increased level of false positive results using the firm's OraQuick Advance Rapid HIV-1/2 Antibody Test with oral fluid, OraSure said. The testing sites have discontinued the use of the product.

OraSure said the majority of sites within the affected regions, as well as many other regions throughout the country, have reported low rates of false positives for oral fluid that are within the label claims for OraQuick Advance. "This is helping progress the company's investigation into site specific factors which may be contributing to unexpected results recently reported," it said.

The company also noted that it has contacted hundreds of customers that represent a large majority of all test usage in the field and will continue to closely monitor test performance throughout the country. Immediately after receiving the reports, OraSure initiated a scientific and systematic evaluation of each situation and has been working in collaboration with affected customers, healthcare officials and government agencies including the Centers for Disease Control and Prevention and the FDA to determine the cause or causes for these unexpected results.