Validation of Solus One Salmonella from Select Food Matrixes and Stainless-Steel and Plastic Environmental Surfaces

Solus One is designed to accurately detect species ( subspecies and ) from select food matrixes and stainless-steel and plastic environmental surfaces. Solus One uses an antibody-based technology test system that is paired with media and our proprietary media supplement, the Solus One supplement combined with a manual or automated sample preparation method. Solus One was evaluated for inclusivity and exclusivity, and a matrix comparison study was done for six food matrixes (raw beef trim, pasteurized liquid egg, raw salmon, cheddar cheese, Romaine lettuce, nonfat dry milk) and two environmental surfaces (stainless steel and polystyrene). Solus One was compared with the U.S. Food and Drug Administration Chapter 5: (July 2018) and the U.S. Department of Agriculture Food Safety and Inspection Service , 4.09 (January 2017) in the matrix study. Both the manual and automated sample preparation methods were performed for cheddar cheese and stainless-steel environmental surfaces. For the inclusivity and exclusivity evaluation, Solus One correctly detected all 108 target organism isolates and correctly excluded all 35 nontarget strains that were analyzed. In the method comparison study, both Solus One manual and automated sample preparation methods demonstrated no significant differences based on probability of detection (POD) statistical analysis between presumptive and confirmed results or between candidate and reference method results for the six food matrixes after 20-22 h and two environmental surfaces after 16-20 h of enrichment time. POD analysis of Solus One method robustness, product consistency, and stability studies using the automated sample preparation method demonstrated no statistically significant differences.