Microbiology Methods for ERP Review 3-2020

135

GENE-UP SLM Matrix Extension

June 19, 2017

1

Discussion 2 The GENE ‐ UP Salmonella method successfully detected Salmonella from all of the food matrices analyzed. 3 Using POD analysis, no statistically significant differences were observed between the number of positive 4 samples detected by the candidate method and the reference methods for all matrices. The false negative 5 result observed with the mTSB as the primary enrichment for beef trim at the 10 hour time point produced 6 a high CP value (37.21) at the 24 hour time point indicating a low level of contamination was present in the 7 sample. This low level of contamination paired with the high level of background flora (1.9 x 10 6 CFU/g) may 8 have contributed to the discrepant result. The GENE ‐ UP Salmonella method correctly identified all 101 9 Salmonella strains tested and the 53 non ‐ Salmonella were correctly not detected. 10 11 The GENE ‐ UP Salmonella method is quick and simple to perform, providing results in less than 1.5 hours 12 post incubation of the selective enrichment for 30 sample replicates. The GENE ‐ UP software is user friendly 13 with the ability to track lot information and sample identification quickly and with ease. The GENE ‐ UP 14 software and instrument also offer the ability to utilize an open platform and set up unique runs before a 15 run is completed. The software also provides the user to analyze each individual CP curve and melting curve 16 as well to help aid in problem solving any issues within an individual reaction. The small footprint is also 17 desirable when working in laboratories with a limited amount of space, or a small PCR amplification room. 20 The results of this study demonstrate that the GENE ‐ UP Salmonella method is statistically equivalent to the 21 reference methods for the detection of Salmonella in the variety of foods evaluated. 18 19 Conclusion

22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46

References

1. U.S. Department of Agriculture, Food Safety and Inspection Service (Jan 2017) Microbiology Laboratory Guidebook, Chapter 4.09, http://www.fsis.usda.gov/wps/wcm/connect/700c05fe ‐ 06a2 ‐

492a ‐ a6e1 ‐ 3357f7701f52/MLG ‐ 4.pdf?MOD=AJPERES, accessed May 2017

2. U.S. Food and Drug Administration (August 2016) FDA Bacteriological Analytical Manual, Chapter 5, http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070149.htm, accessed

May 2017

3. Centers for Disease Control and Prevention: Salmonella. Updated December 30, 2016. (Accessed

May 2017), https://www.cdc.gov/salmonella/

4. Official Methods of Analysis (2012), 19th Ed., Appendix J, AOAC INTERNATIONAL, Gaithersburg,

MD, http://www.eoma.aoac.org/app_j

5. U. S. Food and Drug Administration Bacteriological Analytical Manual , Chapter 3 Aerobic Plate

Count ( January 2001) (Accessed May 2017)

http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm063346.htm

6. Least Cost Formulations, Ltd., MPN Calculator ‐ Version 1.6 (http://www.lcfltd.com/customer/LCFMPNCalculator.exe)

Page 20 of 33