Independent Validation for the Polyskope 1.0 Multiplex Pathogen Detection Assay for the Detection of Shiga Toxin-Producing Escherichia coli Non-O157 STEC, Escherichia coli O157, Listeria monocytogenes, and Salmonella SpeciesAOAC Performance Tested MethodSM 041801

Polyskope 1.0 demonstrated no statistically significant differences between candidate and reference method results or between presumptive and confirmed results for three food matrices and one environmental surface. Results from inclusivity and exclusivity evaluations indicated the test method can accurately detect the target analytes and excluded all nontarget organisms. No differences were observed with the stability or lot-to-lot evaluations. Polyskope 1.0 demonstrated robustness by remaining unaffected by small variations in method parameters, which had no statistically significant effect on the results for all eight variations. Conclusions and Highlights: Polyskope 1.0 was shown to be a specific, highly accurate, and robust method for the detection of Listeria monocytogenes, Salmonella species, non-O157 STECs, and E. coli O157 across four matrices.