77 / 453
13
specific and accurate for identifying
E. coli
O157:H7 in 325 g of raw ground beef than the USDA MLG cultural
1
method.
2
Overall, the data generated during this evaluation demonstrates the reproducibility of the 3M Molecular
3
Detection Assay 2 –
E. coli
O157 (including H7) method. For each matrix, the POD statistical analysis indicated
4
that there is no statistically significant difference between the candidate method and the reference method or
5
between the presumptive and confirmed results of the candidate method.
6
7
Recommendations
8
9
It is recommended that the 3M Molecular Detection Assay 2 –
E. coli
O157 (including H7)method be adopted
0
as Official First Action status for the detection of
E. coli
O157:H7in selected foods: raw ground beef (73% lean),
1
frozen blueberries, fresh sprouts, and fresh babyspinach.
2
3
Acknowledgements
4
5
We would like to extend a sincere thank you to the following collaborators for their dedicated participation in
6
this study:
7
8
Carly Zuban- HVL & Douglas Labs, Pittsburgh, PA
9
David Metzger-Accelerated Analytical, Milwaukee, WI
0
Heidi Wright – AEMTEK, Inc., Fremont CA.
1
Jesse Miller, Bryan Schindler and Eric Budges - NSF International, Ann Arbor, MI
2
Erika Nix-Maryland Department of Agriculture, Annapolis MD
3
Mark Harrison and Gwen Hirsch-University of Georgia, Athens, GA
4
Jean Schoeni-Covance, Madison, WI
5
Angela Winslow-FDA Center for Food Safety, College Park, MD
6
Chris Lopez-Food Safety Net Services, San Antonio, TX
7
David Baumler and Tong Ding-University of Minnesota, St. Paul, MN
8
Patrick Bird and Nicole Klass– Q Laboratories Inc., Cincinnati, OH
9
Ryan Fink, Nusrat A. Jahan, Mary C. Norbeck, SadhanaBom, and Megan Stein-St. Cloud State University, St.
0
Cloud, MN
1
Maria Li and Claudia Diaz-Oklahoma State University, Stillwater, OK
2
3
We would like to extend a special thanks to the following team members at Vanguard Sciences, Inc. for their
4
efforts during the collaborative study: Erin Hoose, Matt Keagle, SamShelton, Mitch Jasper, Eric Draper, Luke,
5
Hannah DeMoss, Haley Zahren, Jonathan Rarrat
6
7
8
References
9
0
(1)ISO 6579. Microbiology of food and animal feeding stuffs – Horizontal method for the detection of
Salmonella
1
spp. Annex B.
2
3
(2)
Official Methods of Analysis
of AOAC INTERNATIONAL. (2012) 19th Ed., Appendix
4
J: AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods
5
for Food and Environmental Surfaces, AOAC INTERNATIONAL, Gaithersburg, MD,
6
http://www.eoma.aoac.org/app_j.pdf (Accessed July 2016)
7
8
(3)U.S. Food and Drug Administration Bacteriological Analytical Manual, (2011)
Chapter 4A: Diarrheagenic
9
OMAMAN-35 A : Collaborative Study Manuscript
For ERP Use Only
January 2017
AOAC Rese rch I stitute
Expert Review Panel Use Only