AOAC-RI ERP Book Micro Jan 19 2017

positive result in its “confirmation stage” at any of the inoculation levels tested. Additionally, for the candidate method versus the reference method, the POD C values were not significantly different from their corresponding POD R values. Based on these outcomes, by fulfilling the criteria to contain 0.000 within the 95% confidence intervals, it can be stated that the probability of detecting a positive result in the candidate method was not significantly different from the probability of detecting a positive results in the reference method. Thus, the candidate method and the reference method can be considered equivalent, based on the AOAC International guidelines. Also, the lack of false positive or false negatives (Table 8 ) when comparing the ‘screening stage’ and the ‘confirmation stage’ of the candidate method further supports the adequacy of the method. Overall, based on the results of this study, the 3M™ Molecular Detection Assay (MDA) is a valid method for the detection of Escherichia coli O157:H7 in 25 g sprouts and 200 g spinach. The candidate methods explored here with the targeted sample sizes produce equivalent results in both the ‘screening stage’ and the ‘confirmation stage’ and produce equivalent results when compared with the FDA BAM reference methods, typically employed for these matrices. 1. Brunelle S, LaBudde R, Nelson M, Wehling P . 2012. AOAC International Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environ-mental Surfaces. Available at: http://www.aoac.org/imis15_prod/AOAC_Docs/StandardsDevelopment/AOAC _Validation_Guidelines_for_Food_Microbiology-Prepub_version.pdf. Accessed: 11/30/15. 2. Feng P, Weagant SD, Jinneman, K. 2011. U.S. Food and Drug Administration Bacteriological Analytical Manual, Chapter 4A: Diarrheagenic Escherichia coli . Available at: http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm070080. htm. Accessed: 11/30/15. 3. United States Department of Agriculture, Food Safety Inspection Service, Office of Public Health Science . 2014. Microbiology Laboratory Guidebook Method 5.09: Detection, Isolation and Identification of Escherichia coli O157:H7 from Meat Product and Carcass and Environmental Sponges. Available at: http://www.fsis.usda.gov/wps/wcm/connect/51507fdb-dded-47f7- 862d-ad80c3ee1738/MLG-5pdf?MOD=AJPERES. Accessed: 11/30/2015. 5.0 REFERENCES

CONFIDENTIAL INFORMATION Page 16 of 17