Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMAMAN-30 D/ PTM Validation Report 081501 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 monocytogenes for the Detection of Listeria monocytogenes in a Variety of Foods and

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Environmental Surfaces

AOAC Performance Tested Methods SM XXXXXX

Abstract

The 3M ™ Molecular Detection Assay 2 (MDA2)– Listeria monocytogenes for the detection of Listeria monocytogenes was evaluated following the AOAC Research Institute Performance Tested Methods SM program guidelines.The evaluation included inclusivity/exclusivity, lot-to- lot/stability, robustness and matrix studies. The 3M MDA2 – Listeria monocytogenes was compared to various reference methods for beef hot dogs, deli turkey, raw chicken leg pieces, sealed concrete, plastic, stainless steel, whole melons, bagged raw spinach, romaine lettuce, cold smoked salmon, queso fresco, 4% milk fat cottage cheese, 3% chocolate whole milk and vanilla ice cream 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)/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/test portion with the exception of raw chicken leg pieces. Naturally contaminated raw chicken leg pieces 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 test area, five replicates were analyzed at a high level of ~100 CFU/standard test 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, 50 target organisms and 30 non-target organisms were tested following the 3M MDA2 – Listeria monocytogenes 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 MDA2 – Listeria monocytogenes and its ability to accurately detect Listeria monocytogenes in select food matrices and environmental

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AOAC Research Institute Expert Review Panel Use Only

surfaces, 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

Agin, David Goins, Q Laboratories, Inc.

Submitting Company

3M Company

Food Safety Department 3M Center, Bldg. 275-5W-05 St. Paul, MN 55144-1000 Independent Laboratory Q Laboratories, Inc.

04/05/2019