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