AOAC-RI ERP Micro June 2016

OMAMAN-29 A/ Collaboartive Study Manuscript OMA ERP June 2016 ERP Use Only

Evaluation of the 3M ™ Molecular Detection Assay(MDA) 2 – Listeria 1 for the Detection of Listeria species in Select Foods and 2 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 uses loop-mediated 16 isothermal amplification and bioluminescence detection to rapidly detect Listeria 17 species in a broad range of food types and environmental surfaces. Using an 18 unpaired study design, the MDA 2 - Listeria was compared to the United States 19 Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) 20 Microbiology Laboratory Guidebook (MLG) Chapter 8.09 Isolation and 21 Identification of Listeria monocytogenes from Red Meat, Poultry and Egg 22 Products, and Environmental Samples reference method for the detection of 23 Listeria in deli turkey and raw chicken breast fillet.Technicians from13laboratories 24 located within the continental United Statesand Canada participated in the 25 collaborative study. Each matrix was evaluated at three levels of contamination: 26 an un-inoculated control level (0 colony forming units (CFU)/test portion) , a low 27 inoculum level (0.2-2 CFU/test portion) and a high inoculum level (2-5 CFU/test 28 portion).Statistical analysis was conducted according to the Probability of 29 Detection (POD) statistical model.Results obtained for the low inoculum level test 30 portions produced a dLPOD value with 95% confidence intervals of 0.04, (-0.08, 31 0.17) for deli turkey indicating no statistically significant difference between the 32 candidate and reference methods. For raw chicken breast fillet a dLPOD 33 valuewith 95% confidence interval of 0.16, (0.04, 0.28) indicating 34 astatisticallysignificant differencebetween the candidate and reference methods 35 with a positive correlation in data indicating more recovery of the target analyte 36 by the candidate method. 37 ___________________________________________________________________________ 38 Listeria, particularly L. monocytogenes , is a pathogenic bacterium that contaminates food and is 39 often found in food manufacturing facilities [1]. Due to the ubiquitous nature of Listeria , this 40 organism is used as a hygiene indicator in all stages of the food processing chain. Detection of 41 Listeria in the production and process facilities may be an indicator of unsanitary conditions [2]. 42 Theorganism’sability to survive in extreme conditions make its presence in food a serious issue. 43 In the past year, Listeria has been identified as the source ofseveral high profile outbreaks 44 involving bagged leafy greens and ice cream [3]. The 3M ™ Molecular Detection Assay(MDA) 2 45 - Listeria method,usinga combination of bioluminescence and isothermal amplification of nucleic 46 AOAC Research Institute Exp rt Review Pan l Use Only 6 7 Lisa Monteroso

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