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

The 3M MDA 2 - Listeria monocytogenes 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 MDA 2 - Listeria monocytogenes has not been evaluated with all possible testing protocols or with all possible strains of bacteria. 1.2 Summary of 3M MDA 2 - Listeria monocytogenes and 3M MDA 2 - Listeria PTM and Precollaborative Studies 3M MDA2 - Listeria The 3M MDA2 - Listeria PTM validation study was performed in 2015. The aim of this study was to demonstrate that the 3M MDA2 - Listeria method could detect Listeria species from selected environmental foods and surfaces as claimed by the manufacturer: hot dogs (25g & 125g), salmon (25g), deli turkey (25g & 125g), cottage cheese (25g), vanilla ice cream (25g), queso fresco (25g), spinach (25g), melon (whole), raw chicken leg pieces (25g), raw chicken fillet (25g), concrete (sponge, 225 mL & 100 mL), stainless steel (sponge, 225 mL), plastic (Enviroswab, 10 mL). There was no significant difference between the 3M MDA2 - Listeria method and the reference method for any of the matrices tested using the probability of detection (POD) analysis. All other PTM parameters (inclusivity, exclusivity, ruggedness, stability and lot to lot) showed no significant differences. Approval is pending for this study. 3M MDA2 - Listeria monocytogenes The 3M MDA2 - Listeria monocytogenes PTM validation study was performed in 2015. The aim of this study was to demonstrate that the 3M MDA2 - Listeria monocytogenes method could detect Listeria monocytogenes from selected foods and environmental surfaces as claimed by the manufacturer: hot dogs (25g & 125g), salmon (25g), deli turkey (25g & 125g), cottage cheese (25g), chocolate milk (25 mL), vanilla ice cream (25g), queso fresco (25g), romaine lettuce (25g), melon (whole), raw chicken leg pieces (25g), concrete (sponge, 225 mL & 100 monocytogenes method and the reference method for any of the matrices tested using the probability of detection (POD) analysis.All other PTM parameters (inclusivity, exclusivity, ruggedness, stability and lot to lot) showed no significant differences. Approval is pending for this study. 1.3 Study Directors for Collaborative Study mL), stainless steel (sponge, 225 mL), plastic (Enviroswab, 10 mL). There was no significant difference between the 3M MDA2 - Listeria AOAC Research Institute Expert Review Panel Use Only

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