OraSure getting reports of high false positive readings for OraQuick HIV test

By Ted A. Knutson

Washington, Dec. 20 - OraSure Technologies, Inc. announced Tuesday it has taken action in response to recent reports that clinical sites in San Francisco and New York City and the L.A. Gay and Lesbian Center have recently experienced an increased level of false positive results using the company's OraQuick Advance Rapid HIV-½ Antibody Test with oral fluid.

OraQuick Advance is a rapid screening test for antibodies to both HIV-1 and HIV-2, which can be used at the point of care with oral fluid, finger stick and venipuncture whole blood and plasma samples.

Immediately after receiving the reports of the false positives, the company said it began 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 and the Food and Drug Administration, to determine the cause or causes for these unexpected results. These evaluations include the collection of test data, an assessment of test procedures, specimen collection and other clinical variables, which could affect results at the sites.

OraSure said it has already met with each of the agencies experiencing the high false positive readings and is working to resolve the issues.

OraSure said the findings to date indicate that 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. The company said 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.

Bethlehem, Pa.-based OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.