3种食品致病菌实时荧光核酸恒温扩增试剂盒

目的 以传统国标培养法作为参考比对方法,考察实时荧光核酸恒温扩增(simultaneous amplification and testing, SAT)食品检测试剂盒,在食品中检测致病菌志贺氏菌、大肠埃希氏菌O157：H7/NM,以及阪崎肠杆菌的一致性。方法 以食品中志贺氏菌、大肠埃希氏菌O157：H7/NM和阪崎肠杆菌国标培养法为参考方法,以基因测序法作为确认法。,考量SAT食品检测试剂盒方法的灵敏度、特异性、假阳性率、假阴性率、准确度,同时进行2种方法的显著差检验。结果 3种SAT食品检测试剂盒灵敏度均为100%,假阴性为0；特异性志贺氏菌100%,阪崎肠杆菌100%,大肠埃希氏菌O157：H7/NM 98.4%。大肠埃希氏菌O157：H7/NM假阳性率为1.2%。结论 SAT试剂盒检测方法具有高灵敏度、特异性强、准确度高,无一例漏检。

Validation comparison analysis of 3 kinds of food pathogens simultaneous amplification and testing kit methods

Objective To evaluate the consistency of simultaneous amplification and testing (SAT) in detection of foodborne pathogenic microorganisms such as Shigella, Escherichia coli O157:H7/NM and Enterobacter sakazakii with the traditional national standard culture method as a reference alignment method. Methods The sensitivity, specificity, false positive rate, false negative rate and accuracy of 3 SAT kits for Shigella, Escherichia coli O157:H7/NM and Enterobacter sakazakii were investigated with the national standards method as reference and the method of molecular sequencing as validation. Meanwhile, the significant difference of positive rate was analyzed by the chi-square test. Results The sensitivities of 3 SAT kits were all 100%, and there were no false negative and misdetection rate. The specificities of Shigella, Escherichia coli O157:H7/NM and Enterobacter sakazakii were 100%, 100%, and 98.4%, respectively, which all conformed to the requirements of the test. The false positive rate of Escherichia coli O157:H7/NM was 1.2%. Conclusion The SAT method has the advantages of high sensitivity, specificity, and accuracy, and has no missing detection.