AOAC-RI ERP Micro June 2016

OMAMAN-29 D/ PTM Validation Report 111501 OMA ERP - June 2016 ERP Use Only

recommends evaluation of the method including enrichment medium, in the user’s environment using a sufficient number of samples with particular foods and microbial challenges to ensure that the method meets the user’s criteria.”

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Conclusion

The 3M MDA 2 - Listeria AOAC PTM validation study included inclusivity/exclusivity, lot-to- lot/stability, robustness and matrix studies. The 3M MDA 2 - Listeria was compared to the USDA/FSIS-MLG 8.09, the FDA-BAM Chapter 10, the AOAC 993.12 or the ISO 11290-1/A1 reference methods for the detection of Listeria . There were no significant differences between the 3M MDA 2 - Listeria method and the corresponding reference method for any of the matrixes evaluated. The 3M MDA 2 - Listeria demonstrated reliability as a rapid and sensitive method for the detection of Listeria species for the following new matrixes: beef hot dogs (25 g), deli turkey (125 g), queso fresco (25 g), vanilla ice cream (25 g), 4% milk fat cottage cheese (25 g), whole melon, bagged raw spinach (25 g), cold smoked salmon (25 g), raw chicken (25 g), sealed concrete (sponge enriched in 225 mL), plastic (Enviroswab enriched in 10 mL), stainless 1. Food and Drug Administration Bacteriological Analytical Manual Chapter 10: Detection and Enumeration of Listeria monocytogenes in Foods . February, 2013. (Accessed January 2015), http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm071400.htm 2. United States Department of Agriculture Microbiological Laboratory Guidelines 8.09: Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry and Egg Products, and Environmental Samples . May 1 st , 2013. (Accessed January 2015) http://www.fsis.usda.gov/wps/wcm/connect/1710bee8-76b9-4e6c-92fc-fdc290dbfa92/MLG- 3. Official Methods of Analysis of AOAC INTERNATIONAL (2012) 19th Ed., AOAC Official Method 993.12 Listeria monocytogenes in Milk and Dairy Products: Selective Enrichment AOAC Research Institute Expert Review Panel Use Only and Isolation Method, First Action 1993, Final Action 1996 4. ISO 11290-1/A1 (2004) - Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of Listeria monocytogenes - Part 1: detection of 8.pdf?MOD=AJPERES steel (sponge enriched in 225 mL). References

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Listeria monocytogenes in foods,

http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=60313

5. U.S. Food and Drug Administration, and U.S. Food Safety and Inspection Service. 2003. Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods. Available in Docket No. 1999N-1168, Vols. 23 through 28, and at Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat

Foods,