Microbiology Methods for ERP Review 3-2020

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GENE-UP SLM Matrix Extension

June 19, 2017

Matrix Extension Study: Validation of GENE ‐ UP® Salmonella in a Variety of Foods

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Performance Tested Methods SM 061504

Abstract 6 A method modification evaluation of the GENE ‐ UP® Salmonella method was conducted to evaluate the 7 method’s ability to detect Salmonella species in a variety of new food claims. The GENE ‐ UP Salmonella 8 method was compared to the United States Department of Agriculture/Food Safety Inspection Service 9 Microbiological Laboratory Guidelines 4.09 Isolation and Identification of Salmonella from Red Meat, 10 Poultry, Egg and Environmental Samples and the Food and Drug Administration ‐ Bacteriological Analytical 11 Manual Chapter 5: Detection and Enumeration of Salmonella reference methods for 13 food matrixes. The 12 methods were analyzed by testing each matrix at three contamination levels: 20 replicates at a low ‐ level of 13 0.2 ‐ 2.0 CFU/test portion, five replicates at a high ‐ level of 2 ‐ 5 CFU/test portion, and five replicates at an un ‐ 14 inoculated control level of 0 CFU/test portion. There were no statistically significant differences between 15 GENE ‐ UP Salmonella and the reference methods for any matrices analyzed in this study. An inclusivity and 16 exclusivity evaluation was also conducted using the GENE ‐ UP Salmonella method for enrichment media not 17 previously evaluated, modified Trypic Soy Broth and Buffered Peptone Water + potassium sulfite. All 18 inclusivity isolates were correctly detected, and all exclusivity isolates were correctly undetected. The 19 GENE ‐ UP Salmonella demonstrated reliability as a rapid method for the detection of Salmonella in a variety 20 of foods.

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Method Authors

Ronald Johnson, John Mills, Vikrant Dutta

bioMérieux, Inc. 595 Anglum Road

Hazelwood, MO 63042

USA

Submitting Company bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042 Independent Laboratory Q Laboratories, Inc. 1400 Harrison Ave Cincinnati, OH 45214

Scope of Method

a) Target organism . —Salmonella species. 42 43 b) Matrixes . — Chicken carcass rinse (30 mL), raw ground chicken (25 g), beef trim (375 g), raw ground 44 pork (375 g), raw ground bison (375 g), pasteurized liquid egg (100 g), powdered egg (100 g), whey 45 protein powder (375 g), instant nonfat dried milk (375 g), dry pet food (375 g), creamy peanut butter 46 (375 g), dark chocolate (375 g), garlic powder (375 g).

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