ERP Micro December 2019

Summary of the GENE-UP LIS PTM Studies

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The GENE-UP LIS was validated according to AOAC Guidelines (4) in an AOAC ® Performance Tested Method SM 2 (PTM) study. The method was originally validated for raw commingled, whole bovine milk (25 g). It was awarded PTM 3 certificate No. 010901 in January of 2009. Several modification studies were conducted to extend the matrix claims of 4 the assay. In May of 2016, the method was validated for deli ham (25 g & 125 g), deli turkey (25 g), beef hot dogs (25 g), 5 breaded chicken nuggets (25 g), fresh bagged spinach (25 g), fresh bagged lettuce (25 g), cooked shrimp (25 g), smoked 6 salmon (25 g & 125 g), vanilla ice cream (25 g), Mexican soft cheese (25 g) and stainless steel environmental surfaces. 7 After successful completion of testing, it was awarded a new PTM certificate No. 051603. The method was further 8 validated in January 2017 for whole liquid egg (100 g) and whey powder (375 g). In December of 2018 a new 9 certification number, PTM Certification No. 121803, was awarded. 0 During the PTM studies, the candidate method was compared to the USDA – Food Safety Inspection Service (FSIS) 1 Microbiology Laboratory Guidebook (MLG) Chapter 8.10 Isolation and Identification of Listeria monocytogenes from 2 Red Meat, Poultry, Ready-To-Eat Siluriformes (Fish) and Egg Products, and Environmental Samples and the US Food 3 and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) Chapter 10 Detection of Listeria 4 monocytogenes in Foods and Environmental Samples, and Enumeration of Listeria monocytogenes in Foods reference 5 methods. The method comparison studies were compared to the current versions of the reference methods at the time of 6 validation. PTM studies included product consistency and stability studies, robustness studies, inclusivity and exclusivity 7 studies and an independent laboratory study, conducted at Q Laboratories (Cincinnati, OH). Several software updates 8 and a level 2 modification from multi dose format to a unit dose format were also validated during the PTM 9 studies.

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