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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
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lot) showed no significant differences. The method was awarded PTM
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certification number 031208 on March 30, 2012.
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1.3
Study Director for Collaborative Study
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The co-Study Directors for this collaborative study:
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DeAnn L. Benesh
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3M Food Safety Department
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3M Center - Bldg 260-6B-01
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St. Paul, MN 55144-1000
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Phone: 651-736-3594
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Fax: 651-733-1804
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Email:
dbenesh1@mmm.com15
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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
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10 laboratories, with acceptable data, will be needed for the successful completion of this
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study. Qualified laboratories currently using the 3M Molecular Detection system or ho
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will be thoroughly trained by a 3M representative, will act as collaborators for this study.
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A sample letter to collaborators can be found in Appendix 8.1. This letter will be sent to
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each collaborator prior to the start of the study.
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3.0
Collaborative Study Design
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3.1
This collaborative study is designed according to the AOAC INTERNATIONAL
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Methods Committee Guidelines for Validation of Microbiological Methods for
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Food and Environmental Surfaces (2012).
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3.2
The laboratory conducting the study will prepare the test portions. In this study, 2
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food types – raw fresh ground beef (25g) and wet pet food (375g) – will be
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analyzed for
Salmonella
following the 3M Molecular Detection Assay Salmonella
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protocol and the appropriate reference method: raw ground beef (25g,
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USDA/FSIS MLG Ch. 4.05
1 )and wet pet food (375g, FDA-BAM Ch. 5
2 ).
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3.3
Collaborators will receive 36 samples of ground beef: 12 uninoculated control, 12
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low level (target 0.2 – 2.0 cfu/test portion), and 12 high level (target 2 – 5 cfu/test
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portion). Each sample will be divided into two test portions: one will be tested
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using the 3M Molecular Detection Assay
Salmonella
and the other will be tested
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1
http://www.fsis.usda.gov/PDF/MLG_4_05.pdf2
http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm070149.htmDRAFT DOCUMENT
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