AOAC-RI ERP Micro June 2016

OMAMAN-30 A/ Collaborative Study Manuscript OMA ERP June 2016 ERP Use Only

Evaluation of the 3M ™ Molecular Detection Assay(MDA) 2 - Listeria 1 monocytogenes for the Detection of Listeria monocytogenes in Select 2 Foods and Environmental Surfaces: Collaborative Study 3 4 Patrick Bird, Jonathan Flannery, Erin Crowley, James Agin, David Goins 5 Q Laboratories, Inc., 1400 Harrison Ave, Cincinnati, OH 45214 8 3M Food Safety Department, 3MCenter – Bldg. 260-6B-01, St. Paul, MN 55144 9 10 Collaborators: R. Brooks, J. Walia, F. Hernandez, D. Bosco, G. Trevino, A. Brandt, C. Lopez, 11 E. Sjogren, M. Shekhawat, L. Ma, C. Timmons, C. Diaz Proano,A. Calle,Z. Metz, D. Baumler, R. 12 Smith, D. Wood, E. Maranan, C. Chavarria,J. Miller, B. Schindler, C. Gies, E. Budge, Z. Geurin, A. 13 Repeck, C. Zook, C. Barnes, B. Bastin, D. Isfort 14 15 The 3M™ Molecular Detection Assay (MDA) 2 –Listeria monocytogenes usesloop- 16 mediated isothermal amplification of unique DNA target sequences combined 17 with bioluminescence to rapidly detect Listeria monocytogenes in a broad range 18 of food types and environmental surfaces. Using an unpaired study design, 19 technicians from 13 laboratories located in the United States and Canada, 20 compared the 3M MDA 2 - Listeria monocytogenes to the United States Department 21 of Agriculture (USDA) Food Safety Inspection Service (FSIS) Microbiology 22 Laboratory Guidebook (MLG) Chapter 8.09 Isolation and Identification of Listeria 23 monocytogenes from Red Meat, Poultry and Egg Products, and Environmental 24 Samples reference method for the detection of Listeria monocytogenes in deli 25 turkey and raw chicken breast fillet. Each matrix was evaluated at three levels of 26 contamination: an un-inoculated control level 27 (0 colony forming units (CFU)/test portion) , a low inoculum level (0.2-2 CFU/test 28 portion) and a high inoculum level (2-5 CFU/test portion).Statistical analysis was 29 conducted according to the Probability of Detection (POD) statistical 30 model.Results obtained for the low inoculum level test portions produced a 31 dLPOD value with 95% confidence intervals of 0.04, (-0.08, 0.17) for deli turkey 32 indicating no statistically significant difference between the candidate and 33 reference methods. For raw chicken breast fillet a dLPOD valuewith 95% 34 confidence interval of 0.16, (0.04, 0.28) indicating astatisticallysignificant 35 differencebetween the candidate and reference methods with a positive 36 correlation in data indicating more recovery of the target analyte by the candidate 37 method. 38 ___________________________________________________________________________ 39 Listeriamonocytogenes is a highly pathogenic microorganism that contaminates food and can 40 cause non-invasive gastroenteritis, or severe life-threatening illness, referred to as listeriosis [1]. 41 Although rare, listeriosis is associated with high hospitalization and mortality rates [2]. 42 Listeriamonocytogenes is ubiquitous in the environment, often found in soil, water, sewage and 43 damp environments, making it difficult to control in the food processing environment [1]. The 44 organism’s ability to survive in processing facilities has led to some highly publicized recent 45 outbreaks, specifically in ice cream and packaged salads [3]. The 3M ™ Molecular Detection 46 AOAC Research I stitute Expert Review Pan l Use Only 6 7 Lisa Monteroso

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