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1

Evaluation of the 3M

Molecular Detection Assay(MDA) 2 -

Listeria

1

monocytogenes

for the Detection of

Listeria monocytogenes

in Select

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Foods and Environmental Surfaces: Collaborative Study

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4

Patrick Bird, Jonathan Flannery, Erin Crowley, James Agin, David Goins

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Q Laboratories, Inc., 1400 Harrison Ave, Cincinnati, OH 45214

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Lisa Monteroso

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3M Food Safety Department,

3MCenter – Bldg. 260-6B-01, St. Paul, MN 55144

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Collaborators: R. Brooks, J. Walia, F. Hernandez, D. Bosco, G. Trevino, A. Brandt, C. Lopez,

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E. Sjogren, M. Shekhawat, L. Ma, C. Timmons, C. Diaz Proano,A. Calle,Z. Metz, D. Baumler, R.

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Smith, D. Wood, E. Maranan, C. Chavarria,J. Miller, B. Schindler, C. Gies, E. Budge, Z. Geurin, A.

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Repeck, C. Zook, C. Barnes, B. Bastin, D. Isfort

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The 3M™ Molecular Detection Assay (MDA) 2

–Listeria monocytogenes

usesloop-

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mediated isothermal amplification of unique DNA target sequences combined

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with bioluminescence to rapidly detect

Listeria monocytogenes

in a broad range

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of food types and environmental surfaces. Using an unpaired study design,

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technicians from 13 laboratories located in the United States and Canada,

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compared the 3M MDA 2 -

Listeria monocytogenes

to the United States Department

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of Agriculture (USDA) Food Safety Inspection Service (FSIS) Microbiology

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Laboratory Guidebook (MLG) Chapter 8.09

Isolation and Identification of Listeria

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monocytogenes from Red Meat, Poultry and Egg Products, and Environmental

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Samples

reference method for the detection of

Listeria monocytogenes

in deli

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turkey and raw chicken breast fillet. Each matrix was evaluated at three levels of

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contamination: an un-inoculated control level

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(0 colony forming units (CFU)/test portion)

,

a low inoculum level (0.2-2 CFU/test

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portion) and a high inoculum level (2-5 CFU/test portion).Statistical analysis was

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conducted according to the Probability of Detection (POD) statistical

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model.Results obtained for the low inoculum level test portions produced a

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dLPOD value with 95% confidence intervals of 0.04, (-0.08, 0.17) for deli turkey

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indicating no statistically significant difference between the candidate and

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reference methods. For raw chicken breast fillet a dLPOD valuewith 95%

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confidence interval of 0.16, (0.04, 0.28) indicating astatisticallysignificant

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differencebetween the candidate and reference methods with a positive

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correlation in data indicating more recovery of the target analyte by the candidate

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method.

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___________________________________________________________________________

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Listeriamonocytogenes

is a highly pathogenic microorganism that contaminates food and can

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cause non-invasive gastroenteritis, or severe life-threatening illness, referred to as listeriosis [1].

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Although rare, listeriosis is associated with high hospitalization and mortality rates [2].

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Listeriamonocytogenes

is ubiquitous in the environment, often found in soil, water, sewage and

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damp environments, making it difficult to control in the food processing environment [1]. The

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organism’s ability to survive in processing facilities has led to some highly publicized recent

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outbreaks, specifically in ice cream and packaged salads [3]. The 3M

Molecular Detection

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AOAC Research I stitute

Expert Review Pan l Use Only

OMAMAN-30 A/ Collaborative Study Manuscript

OMA ERP June 2016

ERP Use Only