AOAC-RI ERP Book Micro Jan 19 2017

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

Evaluation of the 3M ™ Molecular Detection Assay(MDA) 2 - E. coli 1 (including H7) for the Detection of E. coli O157:H7speciesin 2 SelectedFoods: 3 Collaborative Study Leslie K. Thompson, Cole Liska 6 Vanguard Sciences, 224 N. Derby Lane, North Sioux City, SD, 57049 9 3M Food Safety Department, 3MCenter – Bldg. 260-6B-01, St. Paul, MN 55144 10 11 Collaborators: C. Zuban, D. Metzger, H. Wright, E. Nix, M. Harrison, G. Hirsch, J. Schoeni, A. 12 Winslow, C. Lopez, S. Johnson, D. Baumler, T. Dong, J. Miller, E. Budge, P. Bird, R. Fink, N.A. 13 Jahan, M. Norbeck, S. Bom, M. Stein, M. Li, C. Diaz 14 15 The 3M™ Molecular Detection Assay (MDA) 2 –E. coli O157 (including 16 H7)employs real-time isothermal amplification technology for the rapid and 17 accurate detection of E. coli O157 (including H7) from enriched select food, feed 18 and food process environmental samples.The 3M MDA 2 – E. coli O157 (including 19 H7)was evaluated in a multi-laboratory collaborative study using an unpaired 20 study design. The MDA 2– E. coli O157 (including H7)was compared to the United 21 States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) 22 Microbiology Laboratory Guidebook (MLG) Chapter 5.09 Detection, Isolation and 23 Identification of Escherichia coli O157:H7 from Meat Products and Carcass and 24 Environmental Sponges in raw ground beef (73% lean). Technicians 25 from15laboratories located within the continental United Statesparticipated. Each 26 matrix was evaluated at three levels of contamination: an un-inoculated control 27 level (0 colony forming units (CFU)/test portion) , a low inoculum level (0.2-2 28 CFU/test portion) and a high inoculum level (2-5 CFU/test portion).Statistical 29 analysis was conducted according to the Probability of Detection (POD) 30 statistical model.Results obtained for the low inoculum level test 31 portionsproduced adLPODvalue with 95% confidence intervals of -0.11, (-0.22, 32 0.01) for raw ground beef indicating nostatisticallysignificant differencebetween 33 the candidate and reference methods. 34 AOAC Research Institute Expert Review Panel Use Only Lisa Monteroso 4 5 7 8

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