Purpose: To evaluate several key performance characters of this assay, including inclusivity, exclusivity, limited of detection (LOD), and food and environmental testing.
Methods: Inclusivity was evaluated using 165 strains of Enteritidis and 335 strains of Typhimurium isolated from diverse geographic locations and sources, and 524 strains of non-target Salmonella (representing 166 serovars) and 30 non-Salmonella strains were used for exclusivity. For LOD, ground beef enrichments were artificially spiked with known concentrations of Salmonella and serially diluted for testing. For food and environmental testing, pre- or post-enrichment spiked samples of chicken breast, chicken rinse and chicken house swabs were used.
Results: The assay demonstrated >99.4% inclusivity and 100% exclusivity. LOD was estimated at ≤104 CFU/ml after enrichment. The sensitivity of the assay was shown to be equivalent to a Real-Time PCR Assay for Salmonella in the food and environmental samples tested.
Significance: The results of these studies demonstrated that the novel system method is a fast, simple and accurate method for identifying Salmonella Enteritidis and Typhimurium in food and environmental samples. Furthermore, the assay shares identical PCR cycling parameters with other BAX® System real-time assays, allowing detection of multiple pathogens in a single PCR run in the BAX® System Q7 instrument.