3M Company, Food Safety Department, St. Paul, MN 55144-1000, USA.
Research and Development, Q Laboratories, Cincinnati, OH 45204, USA.
J AOAC Int. 2022 Apr 27;105(3):902-914. doi: 10.1093/jaoacint/qsab146.
The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method is based on gene amplification using real time loop-mediated isothermal amplification with the 3M Molecular Detection System for the rapid and specific detection of Shiga toxin gene (stx1 and/or stx2) and intimin gene (eae) from Shiga toxin-producing enterohemorrhagic Escherichia coli (STEC) in enriched foods.
The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method was evaluated for AOAC® Performance Tested MethodsSM certification.
Matrix studies, inclusivity/exclusivity, robustness, product stability, and lot-to-lot variability testing were conducted to assess the method's performance.
The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) demonstrated equivalent results to the US Department of Agriculture-Food Safety and Inspection Service Microbiology Laboratory Guidebook 5C.00 for fresh raw beef trim and fresh raw ground beef, and to the US Food and Drug Administration Bacteriological Analytical Manual Chapter 4A for fresh spinach. The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) detected 50 of 50 E. coli strains with stx1 and/or stx2 genes, and the eae gene, and detected zero of 40 strains from the exclusivity panel. Robustness testing indicated that small variations in critical test parameters did not adversely affect the assay's performance. Product consistency and stability testing demonstrated no differences between the lots evaluated.
The data collected demonstrates that the 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) is a reliable method for the rapid and specific detection of STEC in raw beef trim, raw ground beef, and spinach.
The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method is suitable for the rapid and specific detection of STECs in raw beef trim, raw ground beef, and spinach.
3M™ Molecular Detection Assay 2 - STEC Gene Screen（stx 和 eae）方法基于使用实时环介导等温扩增基因扩增，利用 3M Molecular Detection System 快速且特异性检测产志贺毒素大肠杆菌（STEC）中的志贺毒素基因（stx1 和/或 stx2）和肠细胞黏附素基因（eae）。
对 3M Molecular Detection Assay 2 - STEC Gene Screen（stx 和 eae）方法进行 AOAC® 性能测试方法 SM 认证。
进行基质研究、包容性/排他性、稳健性、产品稳定性和批间变异性测试，以评估方法的性能。
3M Molecular Detection Assay 2 - STEC Gene Screen（stx 和 eae）与美国农业部-食品安全检验局微生物实验室指南 5C.00 对新鲜生牛肉修剪和新鲜生碎牛肉的结果等效，与美国食品和药物管理局细菌分析手册第 4A 章对新鲜菠菜的结果等效。3M Molecular Detection Assay 2 - STEC Gene Screen（stx 和 eae）检测到 50 株带有 stx1 和/或 stx2 基因和 eae 基因的大肠杆菌菌株，检测到来自排他性检测组的 40 株菌株均为阴性。稳健性测试表明，关键测试参数的微小变化不会对检测产生不利影响。产品一致性和稳定性测试表明，评估的批次之间没有差异。
收集的数据表明，3M Molecular Detection Assay 2 - STEC Gene Screen（stx 和 eae）是一种快速且特异性检测生牛肉修剪、生碎牛肉和菠菜中 STEC 的可靠方法。
3M Molecular Detection Assay 2 - STEC Gene Screen（stx 和 eae）方法适用于快速且特异性检测生牛肉修剪、生碎牛肉和菠菜中的 STEC。
