Purpose: This study evaluated inclusivity, exclusivity, and detection capabilities of the DuPont BAX System X5 PCR assays for Salmonella species and E. coli O157:H7 for detecting these pathogens in a variety of food types.
Methods: Salmonella species (n=112 strains) and E. coli O157:H7 (n=45) inclusivity testing was performed at ~105 CFU/ml, while exclusivity testing (n=48 and n=46, respectively) was performed at ~108 CFU/ml.
For method effectiveness, 2 different foods (ground beef and romaine lettuce) for Salmonella species and 3 different foods (raw beef trim, romaine lettuce and red leaf lettuce) for E. coli O157:H7 were inoculated at fractional positive levels and evaluated using the BAX System X5 PCR assays. All samples were culture confirmed following either the FDA-BAM or USDA-FSIS MLG reference method.
Results: The collection of strains evaluated demonstrated 100% inclusivity for the target organisms. Testing using non-target strains for both assays demonstrated 100% exclusivity. For effectiveness testing, 240 PCR tests were performed across all matrix/media/enrichment/time conditions with a >98% concordance to culture confirmation. Analysis using the AOAC POD model indicated PCR and culture results were statistically indistinguishable.
Significance: This study indicates that the BAX® System X5 PCR assays for Salmonella and E. coli O157:H7 are a rapid and sensitive method for detecting these pathogens in food. Test kit results demonstrated no significant difference when compared with the reference culture methods.