AOAC-RI ERP Micro June 2016

OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol OMA ERP - June 2016 ERP Use Only

3M MDA 2 Listeria species and L. monocytogenes Collaborative Study OMA-2016-MONTH-XXX

INTRODUCTION The goal of this collaborative study is to validate the 3M™ MDA 2(MDA2)- Listeria and the 3M™ MDA 2 - Listeria monocytogenes using deli turkey (125g) and raw chicken breast (25g). Test portions from 3 different contamination levels, including negative controls, will be sent to approximately 12 laboratories who will perform a comparison study between the 3M MDA2 methods and the USDA/FSIS Microbiological Laboratory Guidebook Chapter 8.09 Revision 09 “Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry and Egg Products, and Environmental Samples” (deli turkey and raw chicken breast). Data will be evaluated using probability of detection (POD) analysis and the difference in the POD at 3 contamination levels for both the candidate and reference method. 1.1 Description of the 3M MDAs 3M MDA2- Listeria 3M™ MDA2 - Listeria is used with the 3M™ Molecular Detection System (MDS) for the rapid and specific detection of Listeria species in enriched food and environmental samples. The 3M MDAs use loop-mediated isothermal amplification to rapidly amplify nucleic acid sequences with high specificity and sensitivity, combined with bioluminescence to detect the amplification. Presumptive positive results are reported in real-time while negative results are displayed after the assay is completed. Presumptive positive results should be confirmed using your preferred method or as specified by local regulations. The 3M MDA2 - Listeria is intended for use in a laboratory environment by professionals trained in laboratory techniques. 3M has not documented the use of this product in industries other than food or beverage. For example, 3M has not documented this product for testing water, pharmaceutical, cosmetics, clinical or veterinary samples. The 3M 2 - Listeria has not been evaluated with all possible testing protocols or with all possible strains of bacteria. 3M MDA2 - Listeria monocytogenes 3M™MDA2 - Listeria monocytogenes is used with the 3M™ MDS for the rapid and specific detection of Listeria species in enriched food and environmental samples. The 3M MDAs use loop-mediated isothermal amplification to rapidly amplify nucleic acid sequences with high specificity and sensitivity, combined with bioluminescence to detect the amplification. Presumptive positive results are reported in real-time while negative results are displayed after the assay is completed. Presumptive positive results should be confirmed using your preferred method or as specified by local regulations.

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AOAC Research In titute Expert Review Pane Use Only

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