免疫胶体金法用于碳青霉烯耐药肠杆菌耐药分型的临床应用研究

Study on clinical application of immune colloidal gold method in drug resistance typing of carbapenems resistant enterobacter

目的评价免疫层析方法产品用于碳青霉烯耐药肠杆菌(carbapenems resistant enterobacter,CRE)的耐药基因进行快速分型的临床应用价值。方法从住院患者临床标本中分离到非重复的195株耐碳青霉烯的肠杆菌科细菌,采用PCR方法和免疫层析方法分别进行检测,以PCR方法作为金标准,对检测结果采用分析软件进行分析,评价其作为碳青霉烯耐药肠杆菌耐药基因快速分型的性能。结果采用PCR方法检出携带KPC酶(质粒介导的肺炎克雷伯菌碳青霉烯酶)基因的菌株136株,检出携带NDM酶(产新德里金属-β-内酰胺酶)基因的菌株52株,5种耐药基因均未检出的7株。采用免疫层析法检出产KPC酶菌株136株,产NDM酶菌株52株,产IMP酶菌株1株,产VIM酶菌株2株,其中1株菌产KPC和IMP两种酶,2株菌产NDM和VIM两种酶,以上5种耐药均未检出的7株。采用免疫层析法检测KPC酶、NDM酶的灵敏度为100%,特异性为100%,阳性预测值为100%,阴性预测值为100%,Youden′s指数为1。结论采用免疫层析法产品对于该碳青霉烯耐药肠杆菌是否携带有KPC和NDM酶,能够准确作出诊断,可用于碳青霉烯耐药肠杆菌的主动分型筛查。

Objective To evaluate the clinical application value of immunochromatographic products for rapid typing of drug resistance genes of carbapenems resistant enterobacter(CRE).Methods One hundred and ninety five non-repetitive CRE isolated from clinical specimens of inpatients in the hospital were detected by PCR and immunochromatography respectively.PCR was used as the gold standard to analyze the test results by means of analysis software and evaluate its performance as a rapid typing of drug resistance genes of CRE.Results Totally 136 strains carrying KPC enzyme(pasmid mediated carbapenemase from Klebsiella pneumoniae) gene and 52 strains carrying NDM enzyme(producing New Delhi metallo-beta-lactamase 1) gene were detected by PCR method, and 7 strains were not detected for the above five kinds of drug resistance genes.Totally 136 strains producing KPC enzyme, 52 strains producing NDM enzyme, 1 strain producing IMP enzyme and 2 strains producing VIM were detected by immunochromatography, and 1 strain producing KPC and IMP enzymes and 2 strains producing NDM and VIM enzymes were detected.Seven strains were not detected for the above five kinds of resistance.The sensitivity of 100%,specificity of 100%,positive predictive value in 100%,negative predictive value in 100%,and Youden’s index in 1 of KPC enzyme and NDM enzyme were detected by means of immunochromatography.Conclusion The immunochromatographic product can accurately diagnose if CRE carries KPC and NDM enzymes, and the product is eligible for active typing and screening of CRE.