AOAC-RI ERP Micro June 2016

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

Appendix 8.8 1 2 3M™ Molecular Detection Assay 2 - Listeria monocytogenes 3 MDA2LMO96 4 5 PRODUCT DESCRIPTION AND INTENDED USE 6 3M™ Molecular Detection Assay 2 - Listeria monocytogenes is used with the 3M™ Molecular 7 Detection System for the rapid and specific detection of Listeria monocytogenes in enriched 8 food and environmental samples. 9 10 The 3M Molecular Detection Assays use loop-mediated isothermal amplification to rapidly 11 amplify nucleic acid sequences with high specificity and sensitivity, combined with 12 bioluminescence to detect the amplification. Presumptive positive results are reported in real- 13 time while negative results are displayed after the assay is completed. Presumptive positive 14 results should be confirmed using your preferred method or as specified by local regulations (1, 2, 15 3) . 16 17 The 3M Molecular Detection Assay 2 - Listeria monocytogenes is intended for use in a 18 laboratory environment by professionals trained in laboratory techniques. 3M has not 19 documented the use of this product in industries other than food or beverage. For example, 3M 20 has not documented this product for testing water, pharmaceutical, cosmetics, clinical or 21 veterinary samples. The 3M Molecular Detection Assay - 2 Listeria monocytogenes has not 22 been evaluated with all possible testing protocols or with all possible strains of bacteria. 23 24 As with all test methods, the source, formulation and quality of enrichment medium can 25 influence the results. Factors such as sampling methods, testing protocols, sample preparation, 26 handling, and laboratory technique may also influence results. 3M recommends evaluation of 27 the method including enrichment medium, in the user’s environment using a sufficient number of 28 samples with particular foods and microbial challenges to ensure that the method meets the 29 user’s criteria. 30 3M has evaluated the 3M Molecular Detection Assay 2 - Listeria monocytogenes with Demi- 31 Fraser Broth containing Ferric Ammonium Citrate. A typical formulation of this medium follows 32 below. AOAC Research Institute Expert Review Panel Use Only

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