AOAC RI ERP Final Action Recommendations eBook

Dupont BAX Salmonella Pre- Collaborative Study For Expert Review Panel Use Only Do Not Distribute

Detection of Salmonella species in a Variety of Foods by the 1 DuPont™ BAX ® System Real-Time PCR Assay for Salmonella : 2 Pre-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 10 Q Laboratories, Inc., 1400 Harrison Avenue, Cincinnati, Ohio 45214 11 12 A single-laboratory study was conducted to evaluate the ability of the DuPont™ BAX® System Real- 13 Time PCR Assay for Salmonella to detect the target species in a variety of foods and environmental 14 surfaces. Internal validation studies were performed by DuPont Nutrition & Health on 18 different 15 sample types to demonstrate the reliability of the test method among a wide variety of sample types. 16 Most sample types tested in this study were artificially contaminated with a Salmonella strain at 17 levels expected to produce low (0.2–2.0 cfu/test portion) or high (5 cfu/test portion) spike levels on 18 the day of analysis; one sample type (chicken wings) was naturally contaminated. The results of the 19 pre-collaborative study demonstrate that there is no statistically significant difference in performance 20 between the BAX® System method and the reference methods for detection of Salmonella for the 21 sample types evaluated. 22 23 Salmonella is a leading cause of foodborne illness. The low infectious dose of the bacterium makes it 24 critical to detect even low concentrations of the Salmonella in foods. Additionally, the presence of high 25 concentrations of closely related non-pathogenic bacteria create the need for highly accurate 26 methodologies. Traditionally, labs concerned with detection of Salmonella screened food samples with 27 culture methods, such as those provided by the United States Department of Agriculture Food Safety 28 and Inspection Service (USDA-FSIS) and the U. S. Food and Drug Administration’s (FDA), which require 29 several days to detect and confirm Salmonella . Rapid methods of screening for Salmonella have been 30 developed, but these generally require two days of enrichment. By contrast, the DuPont™ BAX® System 31 detects the pathogen less than 90 minutes after enrichment, and the DNA-based results are both 32 reliable and reproducible, leading to quicker release of cleared product. 33 Introduction

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