Higgins David, Urquhart Holly, Kelly Siobhan, Illingworth Simon, Perera Nevin, Bastin Benjamin, Bird Patrick, Agin M James, Goins David, Chen Yi, Salfinger Yvonne, Brodsky Michael
Solus Scientific Solutions, Ltd, 9 Mansfield Networkcentre, Millennium Business Park, Concorde Way, Mansfield, Nottinghamshire NG19 7JZ, United Kingdom.
Q Laboratories, Inc., 1400 Harrison Ave, Cincinnati, OH 45214.
J AOAC Int. 2019 Jul 1;102(4):1145-1161. doi: 10.5740/jaoacint.18-0345. Epub 2019 Feb 6.
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.
Solus One旨在从特定的食品基质以及不锈钢和塑料环境表面中准确检测物种（亚种等）。Solus One使用基于抗体的技术测试系统，该系统与培养基以及我们专有的培养基补充剂（Solus One补充剂）相结合，并采用手动或自动样品制备方法。对Solus One进行了包容性和排他性评估，并针对六种食品基质（生牛肉末、巴氏杀菌液态蛋、生三文鱼、切达干酪、长叶生菜、脱脂奶粉）和两种环境表面（不锈钢和聚苯乙烯）进行了基质比较研究。在基质研究中，将Solus One与美国食品药品监督管理局第5章（2018年7月）以及美国农业部食品安全检验局4.09（2017年1月）进行了比较。对切达干酪和不锈钢环境表面同时采用了手动和自动样品制备方法。在包容性和排他性评估中，Solus One正确检测了所有108株目标生物体分离株，并正确排除了所有35株经分析的非目标菌株。在方法比较研究中，Solus One手动和自动样品制备方法在20 - 22小时后对六种食品基质以及16 - 20小时后对两种环境表面进行富集培养后，基于检测概率（POD）统计分析，在推定结果与确认结果之间或候选方法与参考方法结果之间均未显示出显著差异。使用自动样品制备方法对Solus One方法的稳健性、产品一致性和稳定性研究进行的POD分析也未显示出统计学上的显著差异。
