ERP Micro December 2019

Summary of the GENE-UP LMO PTM Studies

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The GENE-UP LMO was validated according to AOAC Guidelines (4) in a Performance Tested Method SM (PTM) 2 study. The method was validated for deli ham (25 g & 125 g), deli roast beef (25 g), deli turkey (25 g), turkey hot dogs 3 (25 g), fresh spinach (25 g), mixed bagged salad (25 g), cooked shrimp (25 g), smoked salmon (25 g), vanilla ice cream 4 (25 g), Mexican soft cheese (25 g &125 g), whole liquid egg (100 g) and whey powder (375 g). After successful 5 completion of testing, it was awarded PTM Certification number, No. 121602. In December of 2018 the method was 6 validated for stainless steel environmental samples a new certification number, PTM Certification No. 121803, was 7 awarded (5). 8 During the PTM studies, the candidate method was compared to the USDA – Food Safety Inspection Service (FSIS) 9 Microbiology Laboratory Guidebook (MLG) Chapter 8.10 Isolation and Identification of Listeria monocytogenes from 0 Red Meat, Poultry, Ready-To-Eat Siluriformes (Fish) and Egg Products, and Environmental Samples (6) and the US 1 Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) Chapter 10 Detection of Listeria 2 monocytogenes in Foods and Environmental Samples, and Enumeration of Listeria monocytogenes in Foods (7) 3 reference methods. The method comparison studies were compared to the current versions of the reference methods at 4 the time of validation. PTM studies included product consistency and stability studies, robustness studies, inclusivity and 5 exclusivity studies and an independent laboratory study, conducted at Q Laboratories (Cincinnati, OH). Several 6 software updates and a level 2 modification from multi dose format to a unit dose format were also validated 7 during the PTM studies.

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