Background The candidate method, SMARTCHEK Salmonella spp. Detection Kit assay is designed for rapid detection of Salmonella spp. in select food matrixes, for use in conjunction with the Genesystems Rapi:chipTM and GENECHECKER UF-300 real-time PCR system. Objective The independent laboratory evaluation consisted of an inclusivity and exclusivity study, product consistency study, robustness study, stability study, and a matrix study. The paired matrix study tested romaine lettuce, peanut butter, liquid whole egg, chicken carcass rinsate, and raw chicken. The robustness study evaluated the method by changing three method parameters. The accelerated stability and product consistency study was conducted at 8, 16, 24, 32, and 40 days. Methods The candidate method was compared to the U.S. Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook 4.10 Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg, and Siluriformes (Fish) Products and Carcass and Environmental Sponges and to the U.S. Food and Drug Administration Bacteriological Analytical Manual, Chapter 5: Salmonella following a paired study design. Results All 108 Salmonella isolates were detected in all three broths tested for inclusivity, while all 35 non-Salmonella isolates were correctly excluded. In the matrix study, the candidate method showed no significant differences between confirmed candidate method results and reference method results for all food matrixes evaluated. Conclusion The candidate method is an effective method for the qualitative detection of Salmonella spp. in select food matrixes. Highlights The SMARTCHEK Salmonella spp. Detection Kit assay allows for fast, reliable detection of Salmonella spp. with results obtained after 24 h of incubation and a PCR run time of only 35 min.

中文翻译：

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SMARTCHEK 沙门氏菌物种检测试剂盒用于 GENECHECKER UF-300 实时 PCR 系统的比较评估，带有 Rapi:chipTM 和 Rapi:DirectTM 裂解缓冲液，用于精选食品：AOAC 性能测试方法SM 032101

背景 候选方法，SMARTCHEK 沙门氏菌属。检测试剂盒检测专为快速检测沙门氏菌而设计。在选择的食品基质中，与 Genesystems Rapi:chipTM 和 GENECHECKER UF-300 实时 PCR 系统结合使用。目的 独立实验室评价包括包容性和排他性研究、产品一致性研究、稳健性研究、稳定性研究和矩阵研究。配对矩阵研究测试了生菜、花生酱、液体全蛋、鸡胴体冲洗液和生鸡肉。稳健性研究通过改变三个方法参数来评估该方法。加速稳定性和产品一致性研究在第 8、16、24、32 和 40 天进行。方法 候选方法与美国比较 农业部食品安全和检验服务微生物实验室指南 4.10 从肉类、家禽、巴氏杀菌蛋和鲶形目（鱼）产品以及尸体和环境海绵中分离和鉴定沙门氏菌以及美国食品和药物管理局细菌分析手册第 5 章：采用配对研究设计的沙门氏菌。结果所有 108 株沙门氏菌在所有 3 种肉汤中检测到，而所有 35 株非沙门氏菌被正确排除。在基质研究中，候选方法在所有评估的食品基质中证实的候选方法结果与参考方法结果之间没有显着差异。结论 候选方法是一种有效的沙门氏菌定性检测方法。在选择的食物矩阵中。亮点 SMARTCHEK 沙门氏菌属。检测试剂盒检测可快速、可靠地检测沙门氏菌属。孵育 24 小时后获得结果，PCR 运行时间仅为 35 分钟。