Background The candidate method, SMARTCHEK® Listeria monocytogenes Detection Kit, is designed for rapid detection of Listeria monocytogenes 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 stainless steel environmental sponges, uncured ready-to-eat deli turkey, ready-to-eat deli ham, cooked shrimp, and fresh bagged spinach. The robustness study evaluated the method by changing three 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 8.11 Isolation and Identification of Listeria monocytogenes from Red Meat, Poultry, Ready-to-Eat Siluriformes (Fish) and Egg Products, and Environmental Samples and to the U.S. Food and Drug Administration Bacteriological Analytical Manual Chapter 10: Detection of Listeria monocytogenes in foods and Environmental Samples, and Enumeration of Listeria monocytogenes in Foods following a paired study design. Results All 50 L. monocytogenes isolates were detected in all three broths tested for inclusivity, while all 37 non-L. monocytogenes isolates were correctly excluded. In the matrix study, the candidate method showed no significant differences between confirmed candidate methods results and reference method results for all food matrixes evaluated. Conclusions The candidate method is an effective method for the qualitative detection of L. monocytogenes in select food matrixes. Highlight The SMARTCHECK® Listeria monocytogenes Detection Kit assay allows for fast, reliable detection of L. monocytogenes with results obtained in approximately 35 min after 18–48 h pre-enrichment, depending on the matrix.

中文翻译：

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SMARTCHECK® 单核细胞增生李斯特菌检测试剂盒用于 GENECHECK® UF-300 实时 PCR 系统的比较评估：AOAC 性能测试方法SM 042101

背景 候选方法 SMARTCHEK® 李斯特菌检测试剂盒专为快速检测选定食品基质中的李斯特菌而设计。与 Genesystems Rapi 结合使用：chipTM 和 GENECHECKER®UF-300 实时 PCR 系统。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不锈钢环保海绵、未腌制的即食熟食火鸡、即食熟食火腿、熟虾和新鲜袋装菠菜。稳健性研究通过改变三个参数来评估该方法。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、食品安全和检验局微生物实验室指南 8.11 从红肉、家禽、即食鲶形目（鱼）和蛋制品以及环境样品中分离和鉴定单核细胞增生李斯特菌，并提交给美国食品和药物管理局细菌学分析手册第 10 章：食品和环境样品中单核细胞增生李斯特菌的检测，以及配对研究设计后食品中单核细胞增生李斯特菌的计数。结果 所有 50 种单核细胞增生李斯特菌分离物在所有三个检测包容性的肉汤中检测到，而所有 37 种非 L. 单核细胞增多症分离株被正确排除。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 候选方法是定性检测选定食品基质中单核细胞增生李斯特菌的有效方法。亮点 SMARTCHECK® 单核细胞增生李斯特菌检测试剂盒检测可快速、可靠地检测单核细胞增生李斯特菌，根据基质，预富集 18-48 小时后大约 35 分钟即可获得结果。