Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

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

OMB Meeting 4-11-2019 Pre-read Materials

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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

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

04/05/2019