AOAC-RI ERP Book Micro Jan 19 2017

OMAMAN-35 B: Collaborative Study Protocol ERP USE ONLY January 2017

3M MDA2 E. coli O157:H7 Collaborative Study

May 2016

OMA-2016-May-XXXX

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The co-Study Directors for this collaborative study:

Lisa Monteroso

3M Food Safety Department 3M Center, Bldg. 275-5W-05 St. Paul, MN 55144-1000 Email: lmonteroso@mmm.com

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Phone: 651-736-2913

Co-SD: TBD

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Collaborators

A total of 15-16 collaborators will be solicited to participate in this study. A minimum of 10 laboratories, with acceptable data, will be needed for the successful completion of this study. Qualified laboratories, familiar with the Molecular Detection System, will act as collaborators. All collaborators have been, or will be, thoroughly trained by a 3M representative on the use of

the Molecular Detection System.

A sample letter to collaborators can be found in Appendix 8.1. This letter will be sent to each

collaborator prior to the start of the study.

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Collaborative Study Design

a) The laboratory conducting the study will prepare the test portions. In this study, raw fresh ground beef (325 g) will be analyzed for E. coli O157:H7 following the 3M MDA2 - E. coli O157 protocol and appropriate reference method. The USDA-FSIS MLG Ch. 5.09 method will be used

as the reference method.

b) Collaborators will receive 72 samples of a test matrix for analysis: 12 un-inoculated controls, 12 low level (target 0.2 – 2.0 cfu/test portion), and 12 high level (target 2 – 5 cfu/test portion) for each method – MDA2 and reference method. See text below and flow diagram 8.5 for the study details. Always reference the 3M MDA2 instructions for use and the MLG reference method for all details. Each laboratory will test all test portions. Each test matrix will be inoculated with an

Table 1. Overview of Study Design AOAC Research Institute Expert Review Panel Use Only

E. coli O157, randomized and blind-coded for analysis.

# Test Portions (per method)

Inoculating organism

Target E. coli O157 Levels

Test Portion Codes

Reference Method

MATRIX

0 cfu/test portion

12

Raw ground beef 325g

USDA/FSIS MLG Ch. 5.09

Random number between 100-199

TBD

0.2-2 cfu/test portion

12

2-5 cfu/test portion

12

DRAFT DOCUMENT

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