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Multilaboratory Validation of a Luminex Microbead-Based Suspension Array for the Identification of the 11 Most Clinically Relevant Shiga Toxin–Producing Escherichia coli O Serogroups

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Abstract:

Rapid and high-throughput identification and serotyping of Shiga toxin–producing Escherichia coli (STEC) O serogroups is important for detecting, investigating, and controlling STEC infection outbreaks and removing hazardous products from commerce. A Luminex microbead-based suspension array has been developed to identify the 11 most clinically relevant STEC serogroups: O26, O45, O91, O103, O104, O111, O113, O121, O128, O145, and O157. Here we present results of a blinded multilaboratory collaborative study involving 10 participants from nine laboratories using 55 unknown strains. From the total 495 analyses, two false-positive and three false-negative results were obtained, indicating the assay to be a rapid, high-throughput, and robust method for identifying clinically relevant STEC serogroups.

Document Type: Research Article

DOI: https://doi.org/10.4315/0362-028X.JFP-12-468

Affiliations: 1: U.S. Food and Drug Administration, San Francisco District, Alameda, California 94502, USA. andrew.lin@fda.hhs.gov 2: U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Regulatory Science, College Park, Maryland 20740, USA 3: U.S. Food and Drug Administration, Pacific Regional Laboratory Northwest, Applied Technology Center, Bothell, Washington 98021, USA 4: U.S. Food and Drug Administration, Pacific Regional Laboratory Southwest, Irvine, California 92612, USA 5: U.S. Food and Drug Administration, San Francisco District, Alameda, California 94502, USA 6: U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Applied Research and Safety Assessments, Laurel, Maryland 20708, USA 7: U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Research, Laurel, Maryland 20708, USA 8: U.S. Food and Drug Administration, Northeast Regional Laboratory, Jamaica, New York 11433, USA 9: U.S. Food and Drug Administration, Pacific Regional Laboratory Northwest, Bothell, Washington 98021, USA 10: U.S. Food and Drug Administration, Denver District Laboratory, Lakewood, Colorado 80225, USA 11: U.S. Food and Drug Administration, Southeast Regional Laboratory, Atlanta, Georgia 30309, USA

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