AOAC RI ERP Final Action Recommendations eBook

FINAL (Version 4)

DuPont™ BAX ® System Real-Time PCR Assay for Salmonella : Collaborative Study

Detection of Salmonella species in a Variety of Foods by the 1 DuPont™ BAX ® System Real-Time PCR Assay for Salmonella : 2 Collaborative Study 3 4 F. Morgan Wallace, Bridget Andaloro, Dawn Fallon, Nisha Corrigan, Stephen Varkey, Daniel DeMarco, 5 Andrew Farnum, Monica Tadler, Steven Hoelzer, Julie Weller, Eugene Davis, Jeffrey Rohrbeck and 6 George Tice 7 DuPont Nutrition & Health, ESL Building 400, Route 141 & Henry Clay Road, Wilmington, Delaware 8 19880 9 Patrick Bird, Erin Crowley, Jonathan Flannery, Kiel Fisher, Travis Huffman, Megan Boyle, M. Joseph 10 Benzinger, Jr., Paige Bedinghaus, Katie Goetz, William Judd, Jim Agin and David Goins 11 Q Laboratories, Inc., 1400 Harrison Avenue, Cincinnati, Ohio 45214 12 15 16 A multi-laboratory study was conducted to evaluate the ability of the DuPont™ BAX® System Real- 17 Time PCR Assay for Salmonella to detect the target species in a variety of foods and environmental 18 surfaces. Internal validation studies were performed by DuPont Nutrition & Health on 24 different 19 sample types to demonstrate the reliability of the test method among a wide variety of sample types. 20 Two of these matrices – pork and turkey frankfurters and pasteurized, not-from-concentrate orange 21 juice without pulp – were each evaluated in 14 independent laboratories as part of the collaborative 22 study to demonstrate repeatability of the internal laboratory results independent of the end user. 23 Frankfurter samples were evaluated against the USDA-FSIS reference method as a paired study, while 24 orange juice samples were evaluated against the FDA-BAM reference method as an unpaired study, 25 using a proprietary media for the test method. 26 All samples tested in this study were artificially inoculated with a Salmonella strain at levels expected 27 to produce low (0.2–2.0 cfu/test portion) or high (5 cfu/test portion) spike levels on the day of 28 analysis. For each matrix, the collaborative study failed to show a statistically significant difference 29 between the candidate method and the reference method using the POD model. Authors Collaborators 13 D. Clark; B. Dieckelman; T. Donohue; H. Elgaali; W. Fedio; E. Galbraith; B. Kupski; K. McCallum; G. 14 McWhorter; J. Meyer; D. Swift; R. Radcliff; D. Rodgers; M. Steele; L. Thompson

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