New Antibody Test for Anthrax

A lateral flow immunoassay contains a monoclonal antibody that is specific for the presence of a cell surface protein found in Bacillus anthracis vegetative cells. The test has been cleared by the U.S. Food and Drug Administration (FDA).

Called RedLine Alert, the test can be used on colonies as early as 12 hours old. Attended time takes as little as 10 minutes and the test can be fully completed within 20 minutes. In the data submitted to the FDA on 145 Bacillus anthracis isolates from 28 countries around the world, the RedLine Alert was 98.6% correct. This compares favorably to the gamma phage lysis, which can require an additional day of culture and is 97.2% correct. In addition, the RedLine Alert had an accuracy of 100% in correctly differentiating B anthracis from 49 other nonhemolytic Bacilli.

The test was developed by Tetracore, Inc. (Gaithersburg, MD, USA). "We are excited to be able to provide a significant new clinical and public health tool to aid in protecting against bio-terrorism threats,” said Dr. Beverly L. Mangold, of Tetracore.





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