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Evaluation of the 3M
™
Molecular Detection Assay(MDA) 2 -
E. coli
1
(including H7) for the Detection of
E. coli
O157:H7speciesin
2
SelectedFoods:
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Collaborative Study
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Leslie K. Thompson, Cole Liska
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Vanguard Sciences, 224 N. Derby Lane, North Sioux City, SD, 57049
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Lisa Monteroso
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3M Food Safety Department,
3MCenter – Bldg. 260-6B-01, St. Paul, MN 55144
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Collaborators: C. Zuban, D. Metzger, H. Wright, E. Nix, M. Harrison, G. Hirsch, J. Schoeni, A.
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Winslow, C. Lopez, S. Johnson, D. Baumler, T. Dong, J. Miller, E. Budge, P. Bird, R. Fink, N.A.
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Jahan, M. Norbeck, S. Bom, M. Stein, M. Li, C. Diaz
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The 3M™ Molecular Detection Assay (MDA) 2
–E. coli
O157 (including
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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
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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
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study design. The MDA 2–
E. coli
O157 (including H7)was compared to the United
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States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS)
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Microbiology Laboratory Guidebook (MLG) Chapter 5.09
Detection, Isolation and
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Identification of Escherichia coli O157:H7 from Meat Products and Carcass and
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Environmental Sponges
in raw ground beef (73% lean). Technicians
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from15laboratories located within the continental United Statesparticipated. Each
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matrix was evaluated at three levels of contamination: an un-inoculated control
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level (0 colony forming units (CFU)/test portion)
,
a low inoculum level (0.2-2
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CFU/test portion) and a high inoculum level (2-5 CFU/test portion).Statistical
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analysis was conducted according to the Probability of Detection (POD)
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statistical model.Results obtained for the low inoculum level test
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portionsproduced adLPODvalue with 95% confidence intervals of -0.11, (-0.22,
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0.01) for raw ground beef indicating nostatisticallysignificant differencebetween
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the candidate and reference methods.
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OMAMAN-35 A : Collaborative Study Manuscript
For ERP Use Only
January 2017
AOAC Research Institute
Expert Review Panel Use Only