AOAC-RI ERP Micro June 2016

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

A Comparative Evaluation of the 3M ™ Molecular Detection Assay 2 (MDA 2) - Listeria for the Detection of Listeria species in a Variety of Foods and Environmental Surfaces

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AOAC Performance Tested Methods SM 111501

Abstract 6 7 The 3M ™ Molecular Detection Assay 2 (MDA2) - Listeria for the detection of Listeria species 8 ( L. monocytogenes, L. seeligeri, L. ivanovii, L. innocua, L. grayi, L. welshimeri, L. fleishmanii 9 subsp . coloradensis, L. marthii , L. grandensis, L. cornellensis and L. riparia) was evaluated 10 following the 2012 AOAC Research Institute Performance Tested Methods SM program 11 guidelines. The evaluation included inclusivity/exclusivity, lot-to-lot/stability, robustness and 12 matrix studies. The 3M MDA 2 - Listeria was compared to various reference methods for raw 13 chicken, bagged raw spinach, cold smoked salmon, deli turkey, whole melons, vanilla ice cream, 14 queso fresco, 4% milk fat cottage cheese, beef hot dogs, stainless steel, sealed concrete and 15 plastic in the matrix study. Twenty replicates of each food matrix were analyzed at a low 16 inoculum level of 0.2-2 colony forming units (CFU)/standard test portion, five replicates were 17 analyzed at a high level of 2-5 CFU/test portion, and five control replicates were analyzed at 0 18 CFU/standard test portion with the exception of naturally contaminated raw chicken (leg pieces) 19 analyzed at the independent laboratory. Naturally contaminated raw chicken (leg pieces), 20 analyzed at the independent laboratory, were evaluated using two separate lots consisting of 21 twenty replicates for each lot. All environmental surfaces were analyzed using twenty replicates 22 at a low inoculum level of ~ 50 CFU/standard area, five replicates were analyzed at a high level 23 of ~ 100 CFU/standard area, and five control replicates were analyzed at 0 CFU/standard test 24 area. Based on the probability of detection statistical model, there were no statistically significant 25 differences between the number of presumptive and confirmed positive samples or between the 26 candidate and reference method. There were no unexpected results in the lot-to-lot/stability, 27 robustness studies. In the inclusivity/exclusivity study, 55 target organisms and 30 non-target 28 organisms were tested following the 3M MDA 2 - Listeria method with all target organisms 29 detected and none of the non-target organisms detected. The results of this evaluation 30 demonstrate the specificity and sensitivity of the 3M MDA 2 - Listeria and its ability to 31 accurately detect Listeria species in select food matrixes (beef hot dogs, queso fresco, vanilla ice 32 cream, 4% milk fat cottage cheese, 3% whole milk, bagged raw spinach, cold smoked salmon, 33 raw chicken parts, deli turkey, whole cantaloupe) and environmental surfaces (stainless steel, 34 sealed concrete, plastic), 24-30 hours post enrichment. AOAC Research Institute Expert Review Panel Use Only Authors Lisa Monteroso and DeAnn Benesh, 3M Food Safety Division Ben Bastin, Jonathan Flannery, Erin Crowley, Patrick Bird, M. Joseph Benzinger, Jr., James

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Agin, David Goins, Q Laboratories, Inc.

Submitting Company

3M Company

Food Safety Department 3M Center, Bldg. 275-5W-05 St. Paul, MN 55144-1000