AOAC-RI ERP Book Micro Jan 19 2017

OMAMAN-35 A : Collaborative Study Manuscript For ERP Use Only January 2017

specific and accurate for identifying E. coli O157:H7 in 325 g of raw ground beef than the USDA MLG cultural 1 method. 2 Overall, the data generated during this evaluation demonstrates the reproducibility of the 3M Molecular 3 Detection Assay 2 – E. coli O157 (including H7) method. For each matrix, the POD statistical analysis indicated 4 that there is no statistically significant difference between the candidate method and the reference method or 5 between the presumptive and confirmed results of the candidate method. 8 9 It is recommended that the 3M Molecular Detection Assay 2 – E. coli O157 (including H7)method be adopted 0 as Official First Action status for the detection of E. coli O157:H7in selected foods: raw ground beef (73% lean), 1 frozen blueberries, fresh sprouts, and fresh babyspinach. 4 5 We would like to extend a sincere thank you to the following collaborators for their dedicated participation in 6 this study: 7 8 Carly Zuban- HVL & Douglas Labs, Pittsburgh, PA 9 David Metzger-Accelerated Analytical, Milwaukee, WI 0 Heidi Wright – AEMTEK, Inc., Fremont CA. 1 Jesse Miller, Bryan Schindler and Eric Budges - NSF International, Ann Arbor, MI 2 Erika Nix-Maryland Department of Agriculture, Annapolis MD 3 Mark Harrison and Gwen Hirsch-University of Georgia, Athens, GA 4 Jean Schoeni-Covance, Madison, WI 5 Angela Winslow-FDA Center for Food Safety, College Park, MD 6 Chris Lopez-Food Safety Net Services, San Antonio, TX 7 David Baumler and Tong Ding-University of Minnesota, St. Paul, MN 8 Patrick Bird and Nicole Klass– Q Laboratories Inc., Cincinnati, OH 9 Ryan Fink, Nusrat A. Jahan, Mary C. Norbeck, SadhanaBom, and Megan Stein-St. Cloud State University, St. 0 Cloud, MN 1 Maria Li and Claudia Diaz-Oklahoma State University, Stillwater, OK 2 3 We would like to extend a special thanks to the following team members at Vanguard Sciences, Inc. for their 4 efforts during the collaborative study: Erin Hoose, Matt Keagle, SamShelton, Mitch Jasper, Eric Draper, Luke, 5 Hannah DeMoss, Haley Zahren, Jonathan Rarrat 9 0 (1)ISO 6579. Microbiology of food and animal feeding stuffs – Horizontal method for the detection of Salmonella 1 spp. Annex B. AOAC Rese rch I stitute Expert Review Panel Use Only 6 7 Recommendations 2 3 Acknowledgements 6 7 8 References

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(2) Official Methods of Analysis of AOAC INTERNATIONAL. (2012) 19th Ed., Appendix 4

J: AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods

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for Food and Environmental Surfaces, AOAC INTERNATIONAL, Gaithersburg, MD,

http://www.eoma.aoac.org/app_j.pdf (Accessed July 2016) 7 8 (3)U.S. Food and Drug Administration Bacteriological Analytical Manual, (2011) Chapter 4A: Diarrheagenic 9

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