AOAC RI ERP Final Action Recommendations - BOOK

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3M Molecular Detection Assay Salmonella Collaborative Study July 2012
OMA-2012-July-XXX
All other PTM parameters (inclusivity, exclusivity, ruggedness, stability and lot to 1
lot) showed no significant differences. The method was awarded PTM 2
certification number 031208 on March 30, 2012. 3
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1.3 Study Director for Collaborative Study 5
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The co-Study Directors for this collaborative study: 7
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DeAnn L. Benesh 9
3M Food Safety Department 10
3M Center - Bldg 260-6B-01 11
St. Paul, MN 55144-1000 12
Phone: 651-736-3594 13
Fax: 651-733-1804 14
Email: 15
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Co-SD: TBD 17
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2.0 Collaborators 19
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A total of 15-16 collaborators will be solicited to participate in this study. A minimum of 21
10 laboratories, with acceptable data, will be needed for the successful completion of this 22
study. Qualified laboratories currently using the 3M Molecular Detection system or ho 23
will be thoroughly trained by a 3M representative, will act as collaborators for this study. 24
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A sample letter to collaborators can be found in Appendix 8.1. This letter will be sent to 26
each collaborator prior to the start of the study. 27
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3.0 Collaborative Study Design 29
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3.1 This collaborative study is designed according to the AOAC INTERNATIONAL 31
Methods Committee Guidelines for Validation of Microbiological Methods for 32
Food and Environmental Surfaces (2012). 33
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3.2 The laboratory conducting the study will prepare the test portions. In this study, 2 35
food types – raw fresh ground beef (25g) and wet pet food (375g) – will be 36
analyzed for Salmonella following the 3M Molecular Detection Assay Salmonella 37
protocol and the appropriate reference method: raw ground beef (25g, 38
USDA/FSIS MLG Ch. 4.05 and wet pet food (375g, FDA-BAM Ch. 5 . 39
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3.3 Collaborators will receive 36 samples of ground beef: 12 uninoculated control, 12 41
low level (target 0.2 – 2.0 cfu/test portion), and 12 high level (target 2 – 5 cfu/test 42
portion). Each sample will be divided into two test portions: one will be tested 43
using the 3M Molecular Detection Assay Salmonella and the other will be tested 44
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