Title: Here a method, there a method, everywhere many methods. What should a laboratory do to validate an assay for the detection of botulinum neurotoxins?

Authors: Shashi K. Sharma, Shuowei Cai, Bal Ram Singh

Addresses: FDA, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-712, College Park, MD 20740, USA. ' Botulinum Research Center, Department of Chemistry and Biochemistry, University of Massachusetts Dartmouth, North Dartmouth, MA 02747-2300, USA. ' Botulinum Research Center, Department of Chemistry and Biochemistry, University of Massachusetts Dartmouth, North Dartmouth, MA 02747-2300, USA

Abstract: Over the past decade, a plethora of new detection methods for Clostridium botulinum Toxins (BoNTs) have been introduced into the bioresearch and bio-defense communities. These methods are on the promise that the detection of BoNTs would be comparable with the mouse bioassay. Furthermore, these methods would be leveraged as a high-throughput system that would identify contaminants more quickly for counter-terrorism purposes. But, few truly novel detection methods have made significant progress. For new advances, challenges, limitations and strategies in the detection, a comprehensive validation strategy is a means to garner equal attention for the successful development of a detection method.

Keywords: Clostridium botulinum; assay validation; FDA; Food and Drug Administration; analytical process; toxins; detection methods; botulinum neurotoxins; BoNT detection; counter-terrorism; botulism.

DOI: 10.1504/TBJ.2008.026467

The Botulinum Journal, 2008 Vol.1 No.2, pp.183 - 198

Published online: 16 Jun 2009 *

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