Title: Utility of Botulinum Toxin ELISA A, B, E, F kits for clinical laboratory investigations of human botulism

Authors: Susan E. Maslanka, Carolina Luquez, Brian H. Raphael, Janet K. Dykes, Lavin A. Joseph

Addresses: National Botulism Laboratory Preparedness Team, Enteric Diseases Laboratory Branch, Centers for Disease Control and Prevention, Atlanta, GA 30329, USA. ' National Botulism Laboratory Preparedness Team, Enteric Diseases Laboratory Branch, Centers for Disease Control and Prevention, Atlanta, GA 30329, USA. ' National Botulism Laboratory Preparedness Team, Enteric Diseases Laboratory Branch, Centers for Disease Control and Prevention, Atlanta, GA 30329, USA. ' National Botulism Laboratory Preparedness Team, Enteric Diseases Laboratory Branch, Centers for Disease Control and Prevention, Atlanta, GA 30329, USA. ' National Botulism Laboratory Preparedness Team, Enteric Diseases Laboratory Branch, Centers for Disease Control and Prevention, Atlanta, GA 30329, USA

Abstract: The Botulinum Toxin ELISA effectively provided presumptive identification of toxin in 1381 investigation samples including clinical specimens, suspect foods, and cultures. Additionally, the ELISA detected all toxins produced by a panel of stock strains representing known subtypes and was negative for non-botulinum toxin producing Clostridium and enteric pathogens. ELISA results were reproducible both within the same kit (CV < 9%) and among different production lots (CV < 23%). Fifty-five of 57 laboratories correctly identified unknown samples in a multi-laboratory study. The ELISA provides a rapid, robust in vitro screening method which will reduce animal dependence during laboratory investigations of botulism.

Keywords: botulinum toxin ELISA; foods; clinical specimens; cultures; human botulism; in vitro botulinum detection; ELISA performance optimisation; botulinum toxin subtypes; diagnostic antibody production; mouse bioassay.

DOI: 10.1504/TBJ.2011.041817

The Botulinum Journal, 2011 Vol.2 No.1, pp.72 - 92

Published online: 06 Aug 2011 *

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