Background The Thermo Scientific SureTect™ Campylobacter jejuni, C. coli, and C. lari PCR Kit is a real-time PCR assay for the detection and differentiation of C. jejuni, C. coli, and C. lari from raw poultry, ready-to-cook poultry products, and environmental samples. Objective The Thermo Scientific SureTect Campylobacter jejuni, C. coli, and C. lari PCR Kit was evaluated for AOAC® Performance Tested MethodsSM certification. Methods Inclusivity/exclusivity, matrix studies, product consistency and stability, and robustness testing were conducted to assess the method’s performance. In the matrix studies, the method was validated against United States and international reference methods for Campylobacter detection. Results There were no statistically significant differences found in the matrix studies between the candidate and reference methods when analyzed by probability of detection. All 52 inclusivity strains and none of the 51 exclusivity strains tested were detected by the assay. Robustness testing demonstrated that the assay gave reliable performance with specific method deviations outside of the recommended parameters, and the real-time stability testing demonstrated that there were no statistically significant differences between kit lots, validating the stated shelf life of the kit. Conclusion The data presented support the product claims that the Thermo Scientific SureTect Campylobacter jejuni, C. coli, and C. lari PCR assay is suitable for the detection and differentiation of C. jejuni, C. coli, and C. lari from raw poultry, ready-to-cook poultry products, and environmental samples. Highlights Presumptive results can be obtained in as little as 23 h. Microaerophilic incubators are not required for enrichment.

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验证 Thermo Scientific SureTect™ 空肠弯曲杆菌、大肠杆菌和落叶梭菌 PCR 试剂盒用于检测生禽和即食家禽产品中的空肠弯曲杆菌、大肠杆菌和落叶松：AOAC 性能测试方法SM 012101

背景 Thermo Scientific SureTect™ 空肠弯曲杆菌、大肠杆菌和落叶梭菌 PCR 试剂盒是一种实时 PCR 检测方法，用于检测和区分生禽中的空肠弯曲杆菌、大肠杆菌和落叶梭杆菌，即用型烹饪家禽产品和环境样品。目的 Thermo Scientific SureTect 空肠弯曲杆菌、大肠杆菌和 C. lari PCR 试剂盒经过 AOAC® Performance Tested MethodsSM 认证评估。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。在基质研究中，该方法针对弯曲杆菌检测的美国和国际参考方法进行了验证。结果在通过检测概率分析时，在候选方法和参考方法之间的矩阵研究中没有发现统计学上的显着差异。该测定法检测到所有 52 种包容性菌株和 51 种排他性菌株均未检测到。稳健性测试表明，该测定在特定方法偏差超出推荐参数的情况下具有可靠的性能，而实时稳定性测试表明，试剂盒批次之间没有统计学上的显着差异，验证了试剂盒规定的保质期。结论 提供的数据支持产品声称 Thermo Scientific SureTect 空肠弯曲杆菌、大肠杆菌和落叶梭菌 PCR 测定适用于检测和区分生禽中的空肠弯曲杆菌、大肠杆菌和落叶梭杆菌，即食家禽产品和环境样品。亮点 预计结果可在 23 小时内获得。富集不需要微需氧培养箱。