MeltPro®TB技术在结核病耐药诊断中的大样本评估  

Large sample evaluation of MeltPro®TB in tuberculosis drug resistance detection

作　　者：陈诚[1] 邵燕[1] 宋红焕[1] 李国莉[1] 刘巧[1] 竺丽梅[1] 陆伟[1] 彭红[1] CHEN Cheng;SHAO Yan;SONG Hong-huan;LI Guo-li;LIU Qiao;ZHU Li-mei;LU Wei;PENG Hong(Jiangsu Provincial Center for Disease Control and Prevention,Jiangsu Nanjing 210009,China)

机构地区：[1]江苏省疾病预防控制中心,江苏南京210009

出　　处：《江苏预防医学》2023年第3期260-263,共4页Jiangsu Journal of Preventive Medicine

基　　金：国家科技重大专项(2018ZX10715002⁃004),江苏省卫生健康委科研课题(M2020040)。

摘　　要：目的评估MeltPro®TB技术在结核病耐药诊断的准确性及与传统药物敏感试验的一致性。方法在国家科技重大专项传染病防治综合示范区所属3个设区市的结核病定点医疗机构,采集患者痰涂片阳性标本进行MeltPro®TB耐药检测,同时开展传统药物敏感试验。以传统药敏试验结果为金标准,计算MeltPro®TB法检测6种抗结核药物及耐多药、准广泛耐药的敏感性、特异性、阳性预测值和阴性预测值,并对2种方法一致性进行Kappa分析。结果2019年1月—2021年4月,采用传统药敏方法有效检测痰涂片阳性患者1892例,纳入1847例结核分枝杆菌对象标本进行分析,耐药率由高到低为链霉素(13.37%)、异烟肼(11.04%)、氧氟沙星(6.95%)、利福平(5.96%)、乙胺丁醇(3.30%)、阿米卡星(1.25%),耐多药率为5.25%,准广泛耐药率为2.11%;同时进行MeltPro®TB检测,耐药率由高到低为链霉素(17.65%)、异烟肼(14.17%)、利福平(8.71%)、氧氟沙星(7.63%)、乙胺丁醇(4.75%)、阿米卡星(1.57%),耐多药率5.86%,准广泛耐药率2.51%。除阿米卡星外,MeltPro®TB法检测其余5种抗结核药物耐药率和耐多药、准广泛耐药率均高于传统药敏试验(P值均<0.05)。和传统药敏试验结果相比,MeltPro®TB检测6种抗结核药物耐药的敏感性为68.42%~92.00%,特异性为93.03%~97.64%,阳性预测值为48.15%~71.11%,阴性预测值为97.92%~99.64%,Kappa值为0.60~0.74;检测耐多药率和准广泛耐药率的敏感性、特异性、阳性预测值、阴性预测值分别为86.05%和83.87%、98.26%和98.99%、71.84%和60.47%、99.27%和99.70%,Kappa值分别为0.77和0.70。结论MeltPro®TB检测异烟肼、利福平、链霉素、氧氟沙星等4种抗结核药物和耐多药、准广泛耐药与传统药敏法一致性较好。Objective To evaluate the accuracy and consistency of the MeltPro®TB technology in the diagnosis of TB drug re⁃sistance compared with conventional drug susceptibility testing.Methods Three designated medical institutions for tuberculosis in three cities of Jiangsu Province were selected to carry out MeltPro®TB evaluation.Sputum smear⁃positive specimens were collected for MeltPro®TB testing and conventional drug susceptibility testing was performed at the same time.With the results of conventional drug susceptibility testing as the gold standard,the sensitivity,specificity,positive predictive value and negative predictive value of six anti⁃tuberculosis drugs,as well as the multidrug resistance(MDR)and pre⁃extensive drug resistance(pre⁃XDR)with MeltPro®TB tech⁃nology were calculated,and the consistency of the two testing methods was analyzed with Kappa value.Results From Jan 2019 to Apr 2021,a total of 1892 sputum smear⁃positive cases were effectively tested with the conventional drug susceptibility method,and 1847 Mycobacterium tuberculosis specimens were included for analysis.From high to low,the drug resistance rates were streptomycin(13.37%),isoniazid(11.04%),ofloxacin(6.95%),rifampicin(5.96%),ethambutol(3.30%)and amikacin(1.25%),and MDR rate was 5.25%and pre⁃XDR rate was 2.11%.Meanwhile with MeltPro®TB technology,the drug resistance rates from high to low were streptomycin(17.65%),isoniazid(14.17%),rifampicin(8.71%),ofloxacin(7.63%),ethambutol(4.75%)and ami⁃cacin(1.57%),and the MDR rate was 5.86%and pre⁃XDR rate was 2.51%.Except amikacin,the drug resistance rate of the other 5 anti⁃tuberculosis drugs,the MDR rate and pre⁃XDR rate detected by MeltPro®TB were all higher than those by conventional drug susceptibility testing(all P<0.05).Compared with the results of conventional drug susceptibility testing,the sensitivity of MeltPro®TB to detect 6 anti⁃tuberculosis drugs was ranged from 68.42%to 92.00%,the specificity was 93.03%to 97.64%,the positive pre⁃dictive value was 48.15%t

关 键 词：结核病 MeltPro®TB法 分子诊断 耐药率 

分 类 号：R521[医药卫生—内科学]