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Applied and Environmental Microbiology, July 2005, p. 3935-3941, Vol. 71, No. 7
0099-2240/05/$08.00+0     doi:10.1128/AEM.71.7.3935-3941.2005

Evaluation of Lateral-Flow Clostridium botulinum Neurotoxin Detection Kits for Food Analysis

Shashi K. Sharma,^1* Brian S. Eblen,¹ Robert L. Bull,² Donald H. Burr,³ and Richard C. Whiting¹

U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, Maryland 20740,¹ Biological Defense Research Directorate, Naval Medical Research Center, Silver Spring, Maryland 20910,² National Center for Food Safety and Technology, Summit-Argo, Illinois 60501³

Received 20 April 2004/ Accepted 8 February 2005

The suitability and sensitivity of two in vitro lateral-flow assays for detecting Clostridium botulinum neurotoxins (BoNTs) in an assortment of foods were evaluated. Toxin extraction and preparation methods for various liquid, solid, and high-fat-content foods were developed. The lateral-flow assays, one developed by the Naval Medical Research Center (Silver Spring, MD) and the other by Alexeter Technologies (Gaithersburg, MD), are based on the immunodetection of BoNT types A, B, and E. The assays were found to be rapid and easy to perform with minimum requirements for laboratory equipment or skills. They can readily detect 10 ng/ml of BoNT types A and B and 20 ng/ml of BoNT type E. Compared to other in vitro detection methods, these assays are less sensitive, and the assessment of a result is strictly qualitative. However, the assay was found to be simple to use and to require minimal training. The assays successfully detected BoNT types A, B, and E in a wide variety of foods, suggesting their potential usefulness as a preliminary screening system for triaging food samples with elevated BoNT levels in the event of a C. botulinum contamination event.

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* Corresponding author. Mailing address: Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., HFS-302, College Park, MD 20740-3835. Phone: (301) 436-1570. Fax: (301) 436-2632. E-mail: Shashi.Sharma{at}cfsan.fda.gov.

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Applied and Environmental Microbiology, July 2005, p. 3935-3941, Vol. 71, No. 7
0099-2240/05/$08.00+0     doi:10.1128/AEM.71.7.3935-3941.2005

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