Xpert MTB/RIF试验用于肺结核快速检测的临床研究  

Clinical evaluation of using Xpert MTB/RIF assay as a rapid diagnosis of tuberculosis

作　　者：刘旭晖[1] 张爱梅[1] 卢水华[1] 

机构地区：[1]上海市公共卫生临床中心呼吸科,201508

出　　处：《中华肺部疾病杂志（电子版）》2016年第5期524-527,共4页Chinese Journal of Lung Diseases(Electronic Edition)

摘　　要：目的探讨XpertMTB／RIF试验用于肺结核病快速检测的诊断价值。方法对上海市公共卫生临床中心呼吸科2014年7月至2015年4月收治的402例肺部疾病患者的呼吸道标本进行XpertMTB／RIF试验检测，选取以下四组人群进行分析研究：①高度支持肺结核诊断的人群；②临床排除肺结核诊断的人群；③常规细菌培养以及XpertMTB／RIF试验提示利福平耐药的人群；④留取下呼吸道样本（支气管镜检）的人群。所有患者都进行了常规细菌学涂片、培养检测进行对照分析。结果XpertMTB／RIF试验在本研究中总的敏感性为84．7％（95％CI，0．81-0．88），特异性为65．5％（95％CI，0．51～0．78），阳性预测值为93．9％（95％CI，0．91～0．96），阴性预测值为40．4％（95％CI，0．30-0．51）。XpertMTB／RIF试验比常规的细菌涂片＋培养的方法敏感性更好（84．7％US．58．8％，P〈0．001）．XpertMTB／RIF试验发现了11．8％的利福平耐药，与常规的细菌学培养结果无显著差异。本研究中XpertMTB／RIF试验对114例下呼吸道灌洗标本的检出率为79．8％（91例），略高于上呼吸道标本（70．2％，P=0．126）。结论XpertMTB／RIF试验用于快速检测肺结核病，其敏感性优于传统的细菌学检测方法，并且能准确预测利福平耐药的出现，是一种值得推荐的新检测手段。XpertMTB／RIF试验对下呼吸道标本中结核菌的检出率略高于上呼吸道标本，两者未见明显统计学差异。Objective To evaluate the clinical performance of Xpert MTB/RIF Assay for the diagnosis of pulmonary tuberculosis. Methods During July, 2014 to April, 2012, 402 cases with pulmonary diseases were involved in this study and respiratory tract specimens were carefully tested. Four groups were identified to analyze ： （ 1 ） patients with clinical diagnosis of pulmonary tuberculosis ; （2） patients clinically excluded from pulmonary tuberculosis; （3） patients with rifampin resistance; （4） patients with bronchial larvae specimen tested. All cases were not treated with anti-tuberculosis drugs before specimen collection and paired specimens were acid fast stained and cultured by Baetec MGIT 960 system. Result The overall sensitivity of Xpert MTB/ RIF Assay in this study is 84.7% （95% CI, 0.81 to 0.88）, specificity is 65.5% （95% CI, 0.51 to 0.78）, positive predict value is 93.9% （95% CI, 0.91 to 0.96）, negative predict value is 40.4% （95% CI, 0.30 to 0.51 ）. Xpert MTB/RIF Assay is more sensitivity than traditional culture and acid fast stain method （84.7% vs. 58.8%, P〈0.001）. Rifampin resistance identified by Xpert MTB/RIF Assay is 11.8%, which shows no significant difference with culture method （ 10.7%, P= 0.72）. Lower respiratory tract specimens have relatively higher MTB/RIF Assay positive rate than upper respiratory tract specimens, but no significant difference （P = 0.126）. Conclusion Xpert MTB/RIF test for rapid detection of tuberculosis bacteriology detection method of the sensitivity is better than the traditional, and can accurately predict the emergence of Rifampicin resistance, it can be recommended as a new means of detection. Xpert MTB/RIF test of Mycobaeterium tuberculosis inlower respiratory tract specimens detection rate is slightly higher than that of the upper respiratory tract specimens, while there is no significant difference.

关 键 词：Xpert MTB/RIF试验 聚合酶链式反应 肺结核 耐药性 

分 类 号：R563[医药卫生—呼吸系统]