Microbiology Methods for ERP Review 3-2020

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GENE ‐ UP ® SLM 2 Collaborative Study

July 2019

fresh raw ground beef (80% lean), fresh raw fish, creamy peanut butter, vanilla ice cream and dry pet food; for 30 mL test portions of chicken carcass rinse; for 100 g test portions of pasteurized liquid eggs and powdered egg,; for 375 g test portions of fresh raw ground beef (80% lean), raw beef trim, raw ground pork, raw ground bison, whey protein powder, dry pet food, creamy peanut butter, garlic powder, bulk bagged Romaine lettuce and dark chocolate; for stainless steel environmental sponges. Other precollaborative studies included product consistency and stability studies, robustness studies, inclusivity and exclusivity studies and an independent laboratory evaluation. Several software updates and a level 2 modification from multi dose format to a unit dose format were also validated during the precollaborative studies. Overall the assay was considered equivalent to the reference methods based on the Probability of Detection (POD) analysis.

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Study Director for Collaborative Study

Ron Johnson and John Mills bioMérieux, Inc. 595 Anglum Road, Hazelwood, MO, 63042 Email: ron.johnson@biomerieux.com; john.mills@biomerieux.com Phone: 314 ‐ 452 ‐ 3241

2.0 Collaborators Approximately 15 collaborators will be solicited to participate in this study. A minimum of 10 collaborators, with acceptable data, will be needed for the successful completion of this study. Qualified laboratories, familiar with the GENE ‐ UP system, will act as collaborators. All collaborators have been, or will be, thoroughly trained prior to participating. 3.0 Collaborative Study Design a) The laboratory conducting the study will prepare the test portions. In this study, raw ground beef (80 % lean, 375 g test portions) will be analyzed for Salmonella following the GENE ‐ UP SLM 2 method and the USDA FSIS MLG 4.10 reference method for Salmonella . b) Collaborators will receive 72 samples for analysis: 12 non ‐ inoculated controls, 12 low level (target 0.7cfu/test portion), and 12 high level (target 2 cfu/test portion) for each method – GENE ‐ UP SLM 2 and the reference method. See Table 1 and flow diagram 8.4 for the study details. Always reference the GENE ‐ UP SLM 2 Package Insert and the MLG 4.10 reference method for complete details. Each laboratory will test all test portions. Test portions will be randomized and blind ‐ coded prior to analysis.

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