探讨Xpert MTB/RIF在快速诊断初始耐药肺结核患者中的应用  

To explore the application of Xpert MTB/RIF in rapid diagnosis of initial drug-resistant tuberculosis

作　　者：任欣欣[1] 李志惠[1] 冯秀莉[1] 崔丹[1] 赵杰[1] Ren Xinxin;Li Zhihui;Feng Xiuli;Cui Dan;Zhao Jie(Department of Tuberculosis, Hebei Thoracic Hospital, Shijiazhuang 050041, China)

机构地区：[1]河北省胸科医院结核一科,石家庄050041

出　　处：《国际呼吸杂志》2019年第15期1141-1146,共6页International Journal of Respiration

摘　　要：目的研究肺结核病患者中采用利福平耐药实时荧光定量核酸扩增检测技术(Xpert MTB/RIF)方法进行耐药性快速诊断的敏感性与可靠性,评价Xpert MTB/RIF法在临床实际检验筛选中作用。方法采用全面筛查的方式,将河北省胸科医院所有初治诊断为疑似肺结核的患者,共356例,采集其痰液、肺泡灌洗液样本,送入我院检验科,分别进行胶体金试验、结核菌培养+药敏、X-pert MTB/RIF检测。统计其阳性和阴性人群,比较结核菌培养+药敏在检测耐利福平耐药以及其他耐药的一致性;以液体金试验为菌种测定的金标准,比较X-pert MTB/RIF的敏感度与特异度差异;以结核菌培养+药敏试验为金标准,比较其测定耐药性敏感度和特异度差异;同时以X-pert MTB/RIF对患者痰标本和灌洗液标本进行对比,比较其是否具有差异性。结果(1)利福平耐药作为简化指标的敏感度为100%(78/78),特异度为99.28%(276/278),阳性预测值为97.50%(78/80),阴性预测值为100%(276/276),两者一致性较好(Kappa≥0.75)。(2)以胶体金法为判断结核分枝杆菌的金标准,则X-pert MTB/RIF检测的特异度85.71%(6/7),敏感度99.71%(348/356),阳性预测值为99.71%(348/349),阴性预测值为85.71%(6/7),两者一致性较好(Kappa≥0.75)。(3)以胶体金法为判断结核分枝杆菌的金标准,则X-pert MTB/RIF检测的特异度100%(276/276),敏感度97.50%(78/80),阳性预测值为100%(78/78),阴性预测值为99.28%(276/278),两者一致性较好(Kappa≥0.75)。(4)痰标本与肺泡灌洗液标本结果进行分析,两组数据Kappa≥0.75,一致性较好。(5)X-pert MTB/RIF法检测时间较结核菌培养+药敏法显著缩短(P<0.05),差异有统计学意义。结论X-pert MTB/RIF试验作为一种辅助手段来检测和快速诊断初始耐药肺结核病,具有较高的敏感度和特异度。同时,其检测时间短,较传统方法有明显优势。Objective To study the sensitivity and reliability of rifampicin-resistant real-time fluorescence quantitative nucleic acid amplification detection technology (X pert MTB/RIF) in the rapid diagnosis of drug resistance in pulmonary tuberculosis patients, and to evaluate the role of X pert MTB/RIF in the screening of clinical trials. Methods With the method of comprehensive screening, Hebei Province Chest Hospital all early diagnosis of suspected pulmonary tuberculosis patients, a total of 356 people, taking the sputum, alveolar lavage fluid samples, sent to the hospital clinical laboratory, respectively for the colloidal gold test, sputum tuberculomyces culture+ drug susceptibility test, X-pert MTB/RIF detection.Its positive and negative crowd were detected, consistency of tuberculous culture+ drug sensitivity in testing drug resistance of rifampin and other drug resistance were compared;The sensitivity and specificity of X-pert MTB/RIF were compared using the colloidal gold test as the gold standard for bacterial species determination.The sensitivity and specificity of tuberculum culture and drug susceptibility test were compared.At the same time, X-pert MTB/RIF was used to compare sputum samples and lavage samples of patients, and to compare whether there showed any difference. Results (1)Rifampin resistant as the sensitivity of the simplified index was 100%(78/78), specificity of 99.28%(276/278), positive predictive value was 97.50%(78/80), negative predictive value was 100%(276/276). The two had good consistency (Kappa≥0.75).(2)With colloidal gold method to judge the gold standard of the mycobacterium tuberculosis, X-pert MTB/RIF detection specificity 85.71%(6/7), sensitivity was 99.71%(348/356), positive predictive value was 99.71%(348/349), negative predictive value was 85.71%(6/7). The two had good consistency (Kappa≥0.75).(3)With colloidal gold method to judge the gold standard of the mycobacterium tuberculosis, X-pert MTB/RIF detection specificity 100%(276/276), sensitivity was 97.50%(78/80), positive

关 键 词：泛耐药结核病诊断 核酸扩增技术 利福平 

分 类 号：R521[医药卫生—内科学]