4. AOACRIMicroMethods-2018Awards

201

Evaluation of the 3M ™ Molecular Detection Assay (MDA) 2 - E. coli 1 O157 (including H7) for the Detection of E. coli O157:H7 in Selected 2 Foods: 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, 3M Center – 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 H7) 16 employs real-time isothermal amplification technology for the rapid and accurate 17 detection of E. coli O157 (including H7) from enriched select food samples. The 18 3M MDA 2 – E. coli O157 (including H7) was evaluated in a multi-laboratory 19 collaborative study using an unpaired qualitative study design. The MDA 2 – E. 20 coli O157 (including H7) was compared to the United States Department of 21 Agriculture (USDA) Microbiology Laboratory Guidebook (MLG) Chapter 5.09 22 method (without utilizing the optional PCR screen) for raw ground beef (73% 23 lean). Technicians from 15 laboratories located within the continental United 24 States participated. Each matrix was evaluated at three levels of contamination: 25 an un-inoculated control level (0 colony forming units (CFU)/test portion) , a low 26 inoculum level (0.2-2 CFU/test portion) and a high inoculum level (2-5 CFU/test 27 portion). Statistical analysis was conducted according to the Probability of 28 Detection (POD) statistical model. Results obtained for the low inoculum level 29 test portions produced a dLPOD value with 95% confidence intervals of -0.11, (CI 30 = -0.22 to 0.01) for raw ground beef indicating equivalence between the candidate 31 and reference methods. 32 Lisa Monteroso 4 5 7 8

03/10/2019