Background The Thermo Scientific™ SureTect™ Staphylococcus aureus PCR Assay is a real-time PCR assay for the detection of Staphylococcus aureus in dairy samples. Objective The Thermo Scientific SureTect Staphylococcus aureus PCR Assay was evaluated for AOAC Performance Tested MethodSM certification. Methods Inclusivity/exclusivity, matrix studies, product consistency and stability, and robustness testing were conducted to assess the method’s performance. For the matrix study, the method was validated on the Applied Biosystems™ QuantStudio™ 5 Real-Time PCR instrument and the Applied Biosystems 7500 Fast Real-Time PCR instrument against the ISO 6888-3:2003 Microbiology of food and animal feeding stuffs—Horizontal method for the enumeration of coagulase-positive staphylococci (Staphylococcus aureus and other species)—Part 3: Detection and MPN technique for low numbers, and the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) Ch. 12, Staphylococcus aureus, 2016, reference methods. Results Matrix studies showed no statistically significant differences between the candidate and reference methods or between presumptive and confirmed results. The inclusivity/exclusivity study correctly identified/excluded all strains analyzed. Robustness testing showed no statistically significant difference in assay performance after set method parameter deviations, and product consistency and stability studies demonstrated no statistically significant differences in performance between kit lots at different expiration points. Conclusion The data presented show that the assay is a rapid and reliable workflow for the detection of S. aureus from dairy matrixes. Highlights The PCR assay allows for fast, reliable detection of S. aureus in dairy matrixes with results obtained in as little as 80 min post enrichment.

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验证 Thermo Scientific™ SureTect™ 金黄色葡萄球菌 PCR 测定法用于检测乳制品基质中的金黄色葡萄球菌：AOAC 性能测试方法 SM 052101

背景 Thermo Scientific™ SureTect™ 金黄色葡萄球菌 PCR 检测是一种实时 PCR 检测，用于检测乳制品样品中的金黄色葡萄球菌。目的 Thermo Scientific SureTect 金黄色葡萄球菌 PCR 检测试剂盒已通过 AOAC 性能测试方法 SM 认证进行评估。方法 进行包容性/排他性、矩阵研究、产品一致性和稳定性以及稳健性测试以评估方法的性能。对于基质研究，该方法在 Applied Biosystems™ QuantStudio™ 5 实时荧光定量 PCR 仪器和 Applied Biosystems 7500 快速实时荧光定量 PCR 仪器上进行了验证，符合 ISO 6888-3:2003 食品和动物饲料微生物学—水平凝固酶阳性葡萄球菌（金黄色葡萄球菌和其他菌种）计数方法 第 3 部分：低数量的检测和 MPN 技术，以及美国食品和药物管理局 (FDA) 细菌学分析手册 (BAM) Ch。12、金黄色葡萄球菌，2016，参考方法。结果 矩阵研究显示候选方法和参考方法之间或推定结果和确认结果之间没有统计学上的显着差异。包容性/排他性研究正确识别/排除了所有分析的菌株。稳健性测试表明，在设定方法参数偏差后，测定性能没有统计学上的显着差异，产品一致性和稳定性研究表明，不同有效期的试剂盒批次之间的性能没有统计学上的显着差异。结论 所提供的数据表明，该测定法是一种快速可靠的工作流程，可用于检测金黄色葡萄球菌。来自乳制品基质的金黄色葡萄球菌。亮点 PCR 分析可以快速、可靠地检测乳制品基质中的金黄色葡萄球菌，并在浓缩后 80 分钟内获得结果。