Republic of Korea, Diagnostic Technology Development Team of Genesystem Co, Ltd.
J AOAC Int. 2022 Apr 27;105(3):855-865. doi: 10.1093/jaoacint/qsab117.
The candidate method, SMARTCHEK® Listeria monocytogenes Detection Kit, is designed for rapid detection of L. monocytogenes in select food matrixes, for use in conjunction with the Genesystems Rapi:chipTM and GENECHECKER®UF-300 real-time PCR system.
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.
The candidate method was compared to the US 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 US 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.
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 method results and reference method results for all food matrixes evaluated.
The candidate method is an effective method for the qualitative detection of L. monocytogenes in select food matrixes.
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.
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:chipTM 和 GENECHECKER®UF-300 实时 PCR 系统一起使用。
独立实验室评估包括包容性和排他性研究、产品一致性研究、稳健性研究、稳定性研究和基质研究。配对基质研究测试了不锈钢环境海绵、未固化即食熟食火鸡、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 8、16、24、32 和 40 天进行。
候选方法与美国农业部食品安全检验局微生物实验室指南 8.11 进行了比较，即从红肉、家禽、即食 Siluriformes（鱼类）和蛋制品以及环境样品中分离和鉴定李斯特菌 monocytogenes 以及美国食品和药物管理局细菌分析手册第 10 章：食品和环境样品中的李斯特菌 monocytogenes 检测和食品中李斯特菌 monocytogenes 的计数 following a paired study design。
所有 50 株李斯特菌 monocytogenes 分离株在所有三种测试肉汤中均被检测到，包容性强，而所有 37 株非李斯特菌 monocytogenes 分离株均被正确排除。在基质研究中，候选方法在所有评估的食品基质中，候选方法结果与参考方法结果之间没有显著差异。
候选方法是一种有效的方法，用于定性检测选定食品基质中的李斯特菌 monocytogenes。
SMARTCHECK 李斯特菌检测试剂盒可在大约 35 分钟内快速、可靠地检测李斯特菌 monocytogenes，具体取决于基质，预增菌时间为 18-48 小时。
