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1

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

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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

uses loop-mediated

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isothermal amplification and bioluminescence detection to rapidly detect

Listeria

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species in a broad range of food types and environmental surfaces. Using an

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unpaired study design, the MDA 2 -

Listeria

was compared to the United States

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

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Microbiology Laboratory Guidebook (MLG) Chapter 8.09

Isolation and

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Identification of Listeria monocytogenes from Red Meat, Poultry and Egg

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Products, and Environmental Samples

reference method for the detection of

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Listeria

in deli turkey and raw chicken breast fillet.Technicians from13laboratories

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located within the continental United Statesand Canada participated in the

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collaborative study. Each matrix was evaluated at three levels of contamination:

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an un-inoculated control level (0 colony forming units (CFU)/test portion)

,

a low

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inoculum level (0.2-2 CFU/test portion) and a high inoculum level (2-5 CFU/test

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portion).Statistical analysis was conducted according to the Probability of

29

Detection (POD) statistical model.Results obtained for the low inoculum level test

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portions produced a dLPOD value with 95% confidence intervals of 0.04, (-0.08,

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0.17) for deli turkey indicating no statistically significant difference between the

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candidate and reference methods. For raw chicken breast fillet a dLPOD

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valuewith 95% confidence interval of 0.16, (0.04, 0.28) indicating

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astatisticallysignificant differencebetween the candidate and reference methods

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with a positive correlation in data indicating more recovery of the target analyte

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by the candidate method.

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___________________________________________________________________________

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Listeria,

particularly

L. monocytogenes

, is a pathogenic bacterium that contaminates food and is

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often found in food manufacturing facilities [1]. Due to the ubiquitous nature of

Listeria

, this

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organism is used as a hygiene indicator in all stages of the food processing chain. Detection of

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Listeria

in the production and process facilities may be an indicator of unsanitary conditions [2].

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Theorganism’sability to survive in extreme conditions make its presence in food a serious issue.

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In the past year,

Listeria

has been identified as the source ofseveral high profile outbreaks

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involving bagged leafy greens and ice cream [3]. The 3M

Molecular Detection Assay(MDA) 2

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-

Listeria

method,usinga combination of bioluminescence and isothermal amplification of nucleic

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AOAC Research Institute

Exp rt Review Pan l Use Only

OMAMAN-29 A/ Collaboartive Study Manuscript

OMA ERP June 2016

ERP Use Only