Banerjee Kakolie, Pierson Brittney, Carrier Elijah, Malsick Lauren, Hu Chuxuan, Daudenarde Sophie, Brownell Daniel, Koeris Michael, Crowley Erin, Bird Patrick, Benzinger M Joseph, Flannery Jonathan, Mastalerz Allison, Agin James, Goins David, Salfinger Yvonne, Brodsky Michael, Ziemer Wayne
Sample6, 12 Gill St, Suite 4200, Woburn, MA 01801.
Q Laboratories, Inc., Cincinnati, OH 45214.
J AOAC Int. 2018 Nov 1;101(6):1895-1904. doi: 10.5740/jaoacint.17-0512.
The AOAC Research Institute Program certified Sample6 DETECT/L™ in April 2014 (Certification No. 041401) for the detection of species () on stainless steel environmental surfaces. A modification was approved in January 2016, increasing the concentration of sanitizer-neutralizing reagents in detection reagents, increasing the number of phage in the detection solution, and increasing the sample test volume. Moreover, changes to reduce the number of negative controls and add compatibility with polyurethane sponges were also approved. In this modification, to ensure that DETECT/L continues to meet performance expectations, Sample6 evaluated workflow changes to enhance sensitivity and the ease-of-use of the assay. Changes to the phage concentration and detection threshold, plus the inclusion of a confirmation step (DETECT Check), were validated to obtain better accuracy and optimize assay performance. Inclusivity, exclusivity, and robustness testing were conducted by Sample6 to evaluate the changes. A third-party laboratory compared the DETECT/L assay and the U.S. Department of Agriculture reference method in a stainless steel environmental surface matrix study. The data presented in this report demonstrate that the changes proposed to the DETECT/L assay meet or exceed the performance in the current configuration.
2014年4月，AOAC研究所项目认证了Sample6 DETECT/L™（认证编号：041401）用于检测不锈钢环境表面的（某物种）。2016年1月批准了一项修改，增加了检测试剂中消毒剂中和试剂的浓度，增加了检测溶液中噬菌体的数量，并增加了样品测试体积。此外，减少阴性对照数量以及增加与聚氨酯海绵兼容性的变更也获得批准。在此次修改中，为确保DETECT/L持续满足性能预期，Sample6评估了工作流程的变更，以提高检测的灵敏度和易用性。对噬菌体浓度和检测阈值的变更，以及加入确认步骤（DETECT Check）进行了验证，以获得更高的准确性并优化检测性能。Sample6进行了包容性、排他性和稳健性测试以评估这些变更。在一项不锈钢环境表面基质研究中，第三方实验室将DETECT/L检测方法与美国农业部参考方法进行了比较。本报告中的数据表明，对DETECT/L检测方法提出的变更达到或超过了当前配置下的性能。
