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recommends evaluation of the method including enrichment medium, in the user’s 1
environment using a sufficient number of samples with particular foods and microbial 2
challenges to ensure that the method meets the user’s criteria.” 3
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Conclusion 6
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The 3M MDA 2 - Listeria AOAC PTM validation study included inclusivity/exclusivity, lot-to- 8
lot/stability, robustness and matrix studies. The 3M MDA 2 - Listeria was compared to the 9
USDA/FSIS-MLG 8.09, the FDA-BAM Chapter 10, the AOAC 993.12 or the ISO 11290-1/A1 10
reference methods for the detection of Listeria. There were no significant differences between 11
the 3M MDA 2 - Listeria method and the corresponding reference method for any of the 12
matrixes evaluated. The 3M MDA 2 - Listeria demonstrated reliability as a rapid and sensitive 13
method for the detection of Listeria species for the following new matrixes: beef hot dogs (25 g), 14
deli turkey (125 g), queso fresco (25 g), vanilla ice cream (25 g), 4% milk fat cottage cheese (25 15
g), whole melon, bagged raw spinach (25 g), cold smoked salmon (25 g), raw chicken (25 g), 16
sealed concrete (sponge enriched in 225 mL), plastic (Enviroswab enriched in 10 mL), stainless 17
steel (sponge enriched in 225 mL). 18
19
References 20
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1. Food and Drug Administration Bacteriological Analytical Manual Chapter 10: Detection and 22
Enumeration of Listeria monocytogenes in Foods. February, 2013. (Accessed January 2015), 23
24
25
2. United States Department of Agriculture Microbiological Laboratory Guidelines 8.09: 26
Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry and Egg 27
Products, and Environmental Samples. May 1st , 2013. (Accessed January 2015) 28
29
30
31
3. Official Methods of Analysis of AOAC INTERNATIONAL (2012) 19th Ed., AOAC Official 32
Method 993.12 Listeria monocytogenes in Milk and Dairy Products: Selective Enrichment 33
and Isolation Method, First Action 1993, Final Action 1996 34
35
4. ISO 11290-1/A1 (2004) - Microbiology of food and animal feeding stuffs - Horizontal 36
method for the detection and enumeration of Listeria monocytogenes - Part 1: detection of 37
Listeria monocytogenes in foods, 38
39
40
5. U.S. Food and Drug Administration, and U.S. Food Safety and Inspection Service. 2003. 41
Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria 42
monocytogenes Among Selected Categories of Ready-to-Eat Foods. Available in Docket No. 43
1999N-1168, Vols. 23 through 28, and at 44
45
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AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-29 D/ PTM Validation Report 111501
OMA ERP - June 2016
ERP Use Only