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†

Author:

LIN ANDREW1,KASE JULIE A.2,MOORE MICHELLE M.3,SON INSOOK2,TRAN NELLY4,CLOTILDE LAURIE M.1,JARVIS KAREN5,JONES KELLY6,KASTURI KUPPUSWAMY7,NABE KHAMPHET8,NUCCI MELISSA9,WAGLEY GAIL S.10,WANG FEI6,GE BEILEI6,HAMMACK THOMAS S.2

Affiliation:

1. 1U.S. Food and Drug Administration, San Francisco District, Alameda, California 94502

2. 2U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Regulatory Science, College Park, Maryland 20740

3. 3U.S. Food and Drug Administration, Pacific Regional Laboratory Northwest, Applied Technology Center, Bothell, Washington 98021

4. 4U.S. Food and Drug Administration, Pacific Regional Laboratory Southwest, Irvine, California 92612

5. 5U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Applied Research and Safety Assessments, Laurel, Maryland 20708

6. 6U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Research, Laurel, Maryland 20708

7. 7U.S. Food and Drug Administration, Northeast Regional Laboratory, Jamaica, New York 11433

8. 8U.S. Food and Drug Administration, Pacific Regional Laboratory Northwest, Bothell, Washington 98021

9. 9U.S. Food and Drug Administration, Denver District Laboratory, Lakewood, Colorado 80225

10. 10U.S. Food and Drug Administration, Southeast Regional Laboratory, Atlanta, Georgia 30309, USA

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.

Publisher

International Association for Food Protection

Subject

Microbiology,Food Science

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