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AOAC INTERNATIONAL
EVALUATION OF THE BAX® SYSTEM REAL TIME ASSAY FOR THE
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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
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pathogen in a variety of foods (AOAC- RI Performance Tested Method #100201, AOAC Official
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Method of Analysis 2003.09, and Health Canada Compendium Method MFLP-29). A new BAX®
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System test kit for
Salmonella
, with the proven track record of the previous test kit’s genetic target,
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but the advantages of reformulation as a real-time assay, is proposed for validation in this study.
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An evaluation was conducted on five food matrices and one environmental sample type to compare
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the BAX® System real-time assay for
Salmonella
with the FDA-BAM, USDA-FSIS MLG, and Health
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Canada Compendium culture methods for detecting
Salmonella
spp. Multiple reference methods
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were used in this study to receive a validation applicable to the widest range of customers, who
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require at least a minimal validation using their current reference method before performing internal
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validations with a rapid method such as the BAX® System. All selected sample types (ground beef,
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cream cheese, bagged lettuce, dry pet food, chicken carcass rinses, and stainless steel) were tested
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by DuPont Qualicon, and one food and the environmental matrix were also tested by an independent
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laboratory. No significant difference in test and reference method performance was found for any of
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the matrices tested.
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Inclusivity/exclusivity data was generated which demonstrated that the BAX® System real-time assay
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is reactive for the major serotypes of
Salmonella
and non-reactive to other related non-
Salmonella
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genera. Additionally, ruggedness data was generated to evaluate the performance of the assay to
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deviations outside manufacturer’s recommendations, and accelerated stability studies and lot-to-lot
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evaluations were performed which validated a rational test kit shelf life and demonstrated consistent
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performance across multiple production lots of the assay.
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Dupont BAX Salmonella PTM Report
PTM Certification No. 081201 (08/07/2012)
For Expert Review Panel Use Only
Do Not Distribute