食品中3M™克罗诺杆菌属分子检测系统评价研究

目的：用不同来源的克罗诺杆菌属（阪崎肠杆菌）、不同来源的非目的菌及不同来源的人工染菌食品样品，考核评估3M? MDS分子检测系统（以下简称3M? MDS）对克罗诺杆菌属的检出限、灵敏度、特异性和准确度，以及与国标法（GB4789.40-2016）检验结果的一致性。方法：用3M? MDS对实验室保存的50株已确认克罗诺杆菌属、40株非目的菌株进行检测，确定该试剂盒的检出限、灵敏度和特异性；对240份人工污染不同浓度目的菌样品，用3M? MDS和国标法同时检验，分析方法的准确度和检验结果的一致性。结果：3M? MDS对50株不同来源的克罗诺杆菌属的检测灵敏度为100%，平均检出限为1.79×103CFU/mL；对40株非目的菌检测结果均为阴性，特异性为100%。用3M? MDS与国标方法对人工污染101 CFU/100g、100 CFU/100g 、10-1 CFU/100g克罗诺杆菌属FC718的240份不同来源乳粉、糊精、乳清和乳糖样品进行检测，结果一致性均大于95%，方法准确度为97.5%。结论：3M? MDS方法具有低检出限、高灵敏和特异性特点，在不同食品样品基质中，检验结果呈现良好的准确度，与国标方法检验结果具有高度一致性，是一项适合基层、企业推广的快速、可靠方法。

Evaluation of the 3MTMCronobacter (Enterobacter sakazakii) molecular detection system in food samples

Objective To investigate the detection limit, sensitivity, specificity and accuracy of 3MTMMolecular Detection System for Cronobacter (Enterobacter sakazakii) and its consistency with GB method (GB 4789.40-2016) by testing Cronobacteria from different sources, non-target bacteria and different spiked food samples. Methods Through testing 50 strains of Cronobacter and 40 strains of non-target bacteria in the laboratory, the detection limit, sensitivity and specificity of 3MTM MDS were determined. Its accuracy and consistency with GB method were determined by testing 240 Cronobacter inoculated samples with different concentrtions. Results The detection sensitivity of 3M? MDS to 50 strains of Cronobacter from different sources was 100%, with an average detection limit of 1.79×103 CFU/mL. The test results of 40 strains of non-target bacteria were all negative, and the specificity was 100%.The consistency results of 240 samples of milk powder, dextrin, whey and lactose from different sources of artificially contaminated 101, 100, 10-1 CFU/100 g Cronobacter FC718 were all more than 95% consistent and the method accuracy was 97.5%. Conclusion The 3MTM MDS method is rapid, reliable, sensitive and specific for Cronobacter detection. It showed good accuracy and high consistency with GB method in different food matrix and should be promoted in food industries.