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A Comparative Evaluation of the 3M
™
Molecular Detection Assay 2 (MDA 2) –
Listeria
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monocytogenes
for the Detection of
Listeria monocytogenes
in a Variety of Foods and
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Environmental Surfaces
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AOAC
Performance Tested Methods
SM
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Abstract
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The 3M
™
Molecular Detection Assay 2 (MDA2)–
Listeria monocytogenes
for the detection of
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Listeria monocytogenes
was evaluated following the AOAC Research Institute
Performance
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Tested Methods
SM
program guidelines.The evaluation included inclusivity/exclusivity, lot-to-
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lot/stability, robustness and matrix studies. The 3M MDA2 –
Listeria monocytogenes
was
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compared to various reference methods for beef hot dogs, deli turkey, raw chicken leg pieces,
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sealed concrete, plastic, stainless steel, whole melons, bagged raw spinach, romaine lettuce, cold
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smoked salmon, queso fresco, 4% milk fat cottage cheese, 3% chocolate whole milk and vanilla
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ice cream in the matrix study.Twenty replicates of each food matrix were analyzed at a low
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inoculum level of 0.2-2 colony forming units (CFU)/test portion, five replicates were analyzed at
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a high level of 2-5 CFU/test portion, and five control replicates were analyzed at 0 CFU/test
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portion with the exception of raw chicken leg pieces. Naturally contaminated raw chicken leg
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pieces were evaluated using two separate lots consisting of twenty replicates for each lot. All
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environmental surfaces were analyzed using twenty replicates at a low inoculum level of ~50
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CFU/
standard
test area, five replicates were analyzed at a high level of ~100 CFU/standard test
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area, and five control replicates were analyzed at 0 CFU/standard test area. Based on the
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probability of detection statistical model, there were no statistically significant differences
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between the number of presumptive and confirmed positive samples or between the candidate
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and reference method.There were no unexpected results in the lot-to-lot/stability, robustness
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studies. In the inclusivity/exclusivity study, 50 target organisms and 30 non-target organisms
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were tested following the 3M MDA2 –
Listeria monocytogenes
method with all target organisms
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detected and none of the non-target organisms detected. The results of this evaluation
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demonstrate the specificity and sensitivity of the 3M MDA2 –
Listeria monocytogenes
and its
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ability to accurately detect
Listeria monocytogenes
in select food matrices and environmental
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surfaces, 24-30 hours post enrichment.
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Authors
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Lisa Monteroso and DeAnn Benesh, 3M Food Safety Division
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Ben Bastin, Jonathan Flannery, Erin Crowley, Patrick Bird, M. Joseph Benzinger, Jr., James
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Agin, David Goins, Q Laboratories, Inc.
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Submitting Company
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3M Company
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Food Safety Department
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3M Center, Bldg. 275-5W-05
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St. Paul, MN 55144-1000
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Independent Laboratory
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Q Laboratories, Inc.
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AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-30 D/ PTM Validation Report 081501
OMA ERP - June 2016
ERP Use Only