三种实验室诊断技术对结核分枝杆菌复合群检出率及检测费用的比较研究  

Comparative study on detection rate and detection cost of Mycobacterium tuberculosis complex by three laboratory diagnostic techniques

作　　者：刘彬彬 龚道方 陈振华 郭婧玮 余艳艳 刘丰平 欧阳辉 谭云洪 LIU Bin-bin;GONG Dao-fang;CHEN Zhen-hua;GUO Jing-wei;YU Yan-yan;LIU Feng-ping;OU-Yang hui;TAN Yun-hong(Laboratory of Hu’nan Institute for Tuberculosis Control,Hu’nan Chest Hospital,Changsha 410013,China)

机构地区：[1]湖南省胸科医院(湖南省结核病防治所)检验科,长沙410013

出　　处：《中国防痨杂志》2020年第2期143-148,共6页Chinese Journal of Antituberculosis

基　　金：湖南省自然科学青年基金(2019JJ50299)。

摘　　要：目的评估液基夹层杯涂片法(采用集菌法;简称“涂片法”)、L-J固体培养法(简称“L-J培养法”)、结核分枝杆菌复合群核酸检测(采用恒温扩增法;简称“恒温扩增法”)对结核分枝杆菌复合群的检测效能。方法采用随机数字表法从湖南省120家结核病定点医院中抽取3家作为研究现场,分别为浏阳市人民医院、醴陵市湘东医院、桃江县人民医院。以3家医院2018年11月1日至12月31日就诊的存在可疑肺结核症状的628例患者为研究对象,对同一份痰标本同时采用涂片法、L-J培养法和恒温扩增法进行检测,分析3种检测方法对结核分枝杆菌复合群阳性检出率的差异;并依据《WS 288—2017肺结核诊断》的诊断标准,以临床诊断肺结核作为参考标准,计算各种检测方法的敏感度、特异度、阳性预测值、阴性预测值、一致率;再以患者进行每项检测的实际支出费用为准,计算每种方法的检测费用。结核分枝杆菌复合群检出率在3种检测技术间的两两比较采用χ2检验,检验水准α=0.05/3=0.017。结果628例疑似肺结核患者中,临床确诊为肺结核患者153例(24.4%),NTM肺病患者6例(1.0%)。3种技术检测结果显示,涂片法、L-J培养法和恒温扩增法的结核分枝杆菌复合群阳性检出率(排除6例NTM肺病患者)分别为13.5%(84/622)、14.0%(87/622)和12.2%(76/622),涂片法和L-J培养法,L-J培养法和恒温扩增法,涂片法和恒温扩增法之间比较,差异均无统计学意义(χ2=1.32,P=0.359;χ2=5.83,P=0.024;χ2=4.00,P=0.077)。以临床诊断结果作为参考标准,排除6例非结核分枝杆菌肺病患者和32例培养污染的患者,涂片法、L-J培养法和恒温扩增法的敏感度分别为55.2%(80/145)、57.9%(84/145)、50.3%(73/145);特异度分别为99.6%(443/445)、99.3%(442/445)、99.8%(444/445);阳性预测值分别为97.6%(80/82)、96.6%(84/87)、98.6%(73/74);阴性预测值分别为87.2%(443/508)、87.9%(442/503)、86.0%(444/516);一Objective To evaluate the detection efficiency of Mycobacterium tuberculosis complex by liquid-based interlayer(using the method of collecting bacteria,referred to as“smear method”),L-J solid culture method(referred to as“L-J culture method”)and nucleic acid detection of Mycobacterium tuberculosis complex group(using constant temperature amplification method;referred to as“thermostatic amplification method”).+++Methods---Three hospitals were randomly selected as research sites from the 120 tuberculosis designated hospitals using random number table,including Liuyang People’s Hospital,Liling Xiangdong Hospital,and Taojiang County People’s Hospital.A total of 628 patients with suspected tuberculosis symptoms diagnosed in 3 hospitals from November 1 to December 31,2018 were included as the research subjects.The same sputum specimens were tested by smear method,L-J culture method,and thermostatic amplification method,and then the difference of positive detection rate of Mycobacterium tuberculosis complex by 3 testing methods was analyzed.In addition,according to the diagnostic criteria of《WS 288-2017 Pulmonary Tuberculosis Diagnosis》,the clinical diagnosis of tuberculosis was used as the reference standard,and the sensitivity,specificity,positive predictive value,negative predictive value and consistency of the 3 testing methods were calculated.Based on the actual expenditure of each test performed by the patient,the testing cost of each method was calculated.Comparison of detection rate of Mycobacterium tuberculosis complex among three methods was used by Chi square test,test levelα=0.05/3=0.017.Results Among 628 patients with suspected pulmonary tuberculosis,there were 153(24.4%)patients clinically diagnosed with pulmonary tuberculosis and 6(1.0%)patients with non-tuberculous mycobacterium pulmonary disease.The results of 3 testing methods showed that the positive detection rates of Mycobacterium tuberculosis complex by smear method,L-J culture method,and thermostatic amplification method(exclu

关 键 词：分枝杆菌 结核 临床实验室技术 集落计数 微生物 培养技术 核酸扩增技术 费用效益分析 对比研究 

分 类 号：R446.5[医药卫生—诊断学] R52[医药卫生—临床医学]