3M Company, Food Safety Department, St. Paul, MN 55144-1000, USA.
Q Laboratories, Microbiology Research and Development Laboratory, Cincinnati, OH 45204, USA.
J AOAC Int. 2022 Jun 29;105(4):1136-1145. doi: 10.1093/jaoacint/qsac015.
The 3M™ Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method is based on gene amplification by the use of real-time loop-mediated isothermal amplification when used 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 as a Level 2 method modification to add new matrixes to the certified claim: 25 g fresh raw ground beef (approximately 75% lean), 375 g fresh raw ground pork (approximately 70% lean), 375 g fresh raw poultry parts, and 25 g sprouts.
Matrix studies were conducted to assess the method's performance compared to the U. S. Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook, 5C.00 for meat and poultry, and to the U. S. Food and Drug Administration Bacteriological Analytical Manual, Ch. 4A for sprouts, using an unpaired study design.
The 3M Molecular Detection Assay 2 - STEC Gene Screen (stx and eae) method demonstrated no significant differences between presumptive and confirmed results or between candidate and reference method results for any of the matrixes tested.
The data collected in these studies demonstrate 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 fresh raw ground beef (approximately 75% lean), fresh raw ground pork (approximately 70% lean), fresh raw poultry parts, and sprouts.
3M™ Molecular Detection Assay 2-STEC Gene Screen（stx 和 eae）方法基于实时环介导等温扩增基因扩增，与 3M 分子检测系统一起用于快速和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）和紧密素基因（eae）。
3M Molecular Detection Assay 2-STEC Gene Screen（stx 和 eae）方法被评估为二级方法修改，为已认证的声称添加新基质：25 克新鲜生绞碎牛肉（约 75%瘦肉），375 克新鲜生绞碎猪肉（约 70%瘦肉），375 克新鲜生禽肉部位和 25 克豆芽。
进行基质研究，以评估该方法与美国农业部食品安全检验局微生物实验室指南 5C.00 相比在肉类和家禽方面的性能，以及与美国食品和药物管理局细菌分析手册 Ch.4A 相比在豆芽方面的性能，采用非配对研究设计。
3M Molecular Detection Assay 2-STEC Gene Screen（stx 和 eae）方法在任何测试基质中，推定结果与确认结果之间或候选方法与参考方法结果之间均无显著差异。
这些研究中收集的数据表明，3M Molecular Detection Assay 2-STEC Gene Screen（stx 和 eae）是一种可靠的方法，用于快速和特异性检测新鲜生绞碎牛肉（约 75%瘦肉）、新鲜生绞碎猪肉（约 70%瘦肉）、新鲜生禽肉部位和豆芽中的 STEC。
