Evaluation of the Solus One Method for the Detection of Species on Environmental Surfaces.

Solus One is designed to accurately detect species (, , , , , , and ) from stainless steel and plastic environmental surface matrixes using an antibody-based technology test system paired with proprietary SOLO+ media and combined with manual or automated sample preparation method. Solus One was evaluated for inclusivity and exclusivity and a matrix comparison study for two environmental surfaces. Solus One was compared with the following reference method for the method comparison study: the U.S. Food and Drug Administration Chapter 10 from stainless steel and plastic environmental surfaces. Both the manual and automated preparation methods were performed for stainless steel and plastic environmental surfaces. For the inclusivity and exclusivity evaluation, Solus One correctly identified all 50 target organism isolates and correctly excluded all 30 nontarget strains that were analyzed. In the method comparison study, both Solus One manual and automated preparation methods demonstrated no significant differences based on probability of detection statistical analysis between presumptive and confirmed results or between candidate and reference method results for two environmental surfaces after 22-30 h of enrichment time. Probability of detection analysis of Solus One method robustness, product consistency (lot-to-lot), and stability studies using the automated preparation method demonstrated no statistically significant differences. The data from the study support the product claims of Solus One for the accurate detection of species, using both the manual and automated methods (using the Dynex DS2 instrument), on both environmental surfaces analyzed.