肠道定植CRE筛查技术方法学评价  

Methodology evaluation of screening techniques for CRE colonized in intestinal tract

作　　者：徐琪 潘芬[1] 孙燕 石迎迎 于方圆 张泓[1] XU Qi;PAN Fen;SUN Yan;SHI Yingying;YU Fangyuan;ZHANG Hong(Department of Clinical Laboratory,Children's Hospital Affiliated to Shanghai Jiao Tong University,Shanghai 200062,China)

机构地区：[1]上海交通大学附属儿童医院上海市儿童医院检验科,上海200062

出　　处：《检验医学》2022年第8期761-765,共5页Laboratory Medicine

基　　金：上海市卫生健康委员会面上项目(201940253)。

摘　　要：目的 评价含1μg/mL美罗培南麦康凯琼脂平板(药物筛选法)和粘贴10μg美罗培南纸片的麦康凯琼脂平板(纸片筛选法)在筛查临床粪便样本中肠道定植碳青霉烯类耐药肠杆菌科细菌(CRE)的性能。方法 收集2019年7月—2020年3月上海交通大学附属儿童医院临床送检主动筛查CRE的住院患儿粪便样本306例,分别采用药物筛选法和纸片筛选法检测。以聚合酶链反应(PCR)扩增碳青霉烯酶基因(PCR法)结果为标准,评价药物筛选法和纸片筛选法检测CRE的效能。结果 306例粪便样本中,PCR法CRE阳性检出率为12.1%(37/306),药物筛选法阳性检出率为17.3%(53/306),纸片筛选法阳性检出率为15.4%(47/306)。以PCR法为参考方法,药物筛选法的敏感性、特异性、阳性预测值、阴性预测值和符合率分别为97.3%、93.7%、67.9%、99.6%和94.1%,2种方法一致性较好(Kappa值为0.77,P<0.05);纸片筛选法的敏感性、特异性、阳性预测值、阴性预测值和符合率分别为91.9%、95.2%、72.3%、98.8%和94.8%,2种方法一致性也较好(Kappa值为0.78,P<0.05)。有6例样本药物筛选法和纸片筛选法均为阳性,但PCR法结果为阴性,考虑到CRE可能存在其他耐药机制,因此仍将此6例样本列为CRE筛查阳性。结论 药物筛选法和纸片筛选法均可用于临床肠道定植CRE的筛查,各实验室可根据具体情况选择相应的方法。Objective To evaluate the performance of screening methods by home-made plate containing meropenem 1 μg/mL(drug screening method) and MacConkey agar with 10 μg meropenem(disk screening method) in the screening of carbapenem-resistant Enterobacteriaceae(CRE) colonized in intestinal tract.Methods A total of 306 stool samples for CRE screening were collected from hospitalized children between July 2019 and March 2020,and drug and disk screening methods were used to determine CRE isolates colonized in stool samples. The results of polymerase chain reaction(PCR) amplified carbapenemase genes(PCR screening method)were taken as a standard to evaluate the performance of the 2 screening methods mentioned above. Results Among the 306 stool samples,the positive rate of PCR,drug and disk screening methods were 12.1%(37/306),17.3%(53/306)and 15.4%(47/306),respectively. The PCR screening method was used as a standard,the sensitivity,specificity,positive predictive value,negative predictive value and consistency of drug screening method were 97.3%,93.7%,67.9%,99.6% and 94.1%,respectively,and the Kappa value was 0.77(P<0.05) with good consistency. The sensitivity,specificity,positive predictive value,negative predictive value and consistency of disk screening method were 91.9%,95.2%,72.3%,98.8% and 94.8%,and the Kappa value was 0.78(P<0.05) with good consistency. There were 6 samples as positive both by drug and disk screening methods,but the carbapenemase genes were negative by PCR screening method. Considering CRE isolates might have other drug resistance mechanisms,it should consider those samples as positive for CRE screening. Conclusions The drug and disk screening methods can be applied to screen and determine the CRE colonized in intestinal tract. Clinical laboratories can select the corresponding methods according to the specific situation.

关 键 词：碳青霉烯类耐药肠杆菌科细菌 肠道定植 药物筛选法 纸片筛选法 聚合酶链反应 

分 类 号：R446.11[医药卫生—诊断学]