AOAC RI ERP Final Action Recommendations eBook

Dupont BAX Salmonella PTM Report PTM Certification No. 081201 (08/07/2012) For Expert Review Panel Use Only Do Not Distribute

EVALUATION OF THE BAX® SYSTEM REAL TIME ASSAY FOR THE 1 DETECTION OF SALMONELLA IN SELECTED FOODS

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1. ABSTRACT

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The BAX® System PCR assay for Salmonella was previously validated for the detection of this 5 pathogen in a variety of foods (AOAC- RI Performance Tested Method #100201, AOAC Official 6 Method of Analysis 2003.09, and Health Canada Compendium Method MFLP-29). A new BAX® 7 System test kit for Salmonella , with the proven track record of the previous test kit’s genetic target, 8 but the advantages of reformulation as a real-time assay, is proposed for validation in this study. 9 An evaluation was conducted on five food matrices and one environmental sample type to compare 10 the BAX® System real-time assay for Salmonella with the FDA-BAM, USDA-FSIS MLG, and Health 11 Canada Compendium culture methods for detecting Salmonella spp. Multiple reference methods 12 were used in this study to receive a validation applicable to the widest range of customers, who 13 require at least a minimal validation using their current reference method before performing internal 14 validations with a rapid method such as the BAX® System. All selected sample types (ground beef, 15 cream cheese, bagged lettuce, dry pet food, chicken carcass rinses, and stainless steel) were tested 16 by DuPont Qualicon, and one food and the environmental matrix were also tested by an independent 17 laboratory. No significant difference in test and reference method performance was found for any of 18 the matrices tested. 19 Inclusivity/exclusivity data was generated which demonstrated that the BAX® System real-time assay 20 is reactive for the major serotypes of Salmonella and non-reactive to other related non- Salmonella 21 genera. Additionally, ruggedness data was generated to evaluate the performance of the assay to 22 deviations outside manufacturer’s recommendations, and accelerated stability studies and lot-to-lot 23 evaluations were performed which validated a rational test kit shelf life and demonstrated consistent 24 performance across multiple production lots of the assay.

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