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3M MDA2 E. coli O157:H7 Collaborative Study
May 2016
OMA-2016-May-XXXX
DRAFT DOCUMENT
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The co-Study Directors for this collaborative study:
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Lisa Monteroso
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3M Food Safety Department
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3M Center, Bldg. 275-5W-05
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St. Paul, MN 55144-1000
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Email:
lmonteroso@mmm.com8
Phone: 651-736-2913
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Co-SD: TBD
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2.0
Collaborators
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A total of 15-16 collaborators will be solicited to participate in this study. A minimum of 10
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laboratories, with acceptable data, will be needed for the successful completion of this study.
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Qualified laboratories, familiar with the Molecular Detection System, will act as collaborators.
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All collaborators have been, or will be, thoroughly trained by a 3M representative on the use of
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the Molecular Detection System.
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A sample letter to collaborators can be found in Appendix 8.1. This letter will be sent to each
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collaborator prior to the start of the study.
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3.0
Collaborative Study Design
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a)
The laboratory conducting the study will prepare the test portions. In this study, raw fresh
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ground beef (325 g) will be analyzed for
E. coli
O157:H7
following the 3M MDA2 -
E. coli
O157
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protocol and appropriate reference method. The USDA-FSIS MLG Ch. 5.09 method will be used
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as the reference method.
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b)
Collaborators will receive 72 samples of a test matrix for analysis: 12 un-inoculated controls, 12
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low level (target 0.2 – 2.0 cfu/test portion), and 12 high level (target 2 – 5 cfu/test portion) for
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each method – MDA2 and reference method. See text below and flow diagram 8.5 for the study
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details. Always reference the 3M MDA2 instructions for use and the MLG reference method for
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all details. Each laboratory will test all test portions. Each test matrix will be inoculated with an
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E. coli
O157, randomized and blind-coded for analysis.
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Table 1. Overview of Study Design
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MATRIX
Inoculating
organism
Target
E. coli
O157
Levels
# Test
Portions
(per method)
Test Portion
Codes
Reference
Method
Raw ground
beef
325g
TBD
0 cfu/test portion
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Random number
between 100-199
USDA/FSIS
MLG Ch.
5.09
0.2-2 cfu/test portion
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2-5 cfu/test portion
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OMAMAN-35 B: Collaborative Study Protocol
ERP USE ONLY
January 2017
AOAC Research Institute
Expert Review Panel Use Only