机构地区:[1]复旦大学附属公共卫生临床中心结核科,上海201508
出 处:《中华传染病杂志》2016年第3期174-179,共6页Chinese Journal of Infectious Diseases
摘 要:目的:应用结核分枝杆菌(MTB)/利福平(RIF)耐药实时荧光定量核酸扩增检测技术(Xpert MTB/RIF)对临床肺外组织标本中的 MTB 及其 RIF 耐药性进行检测,探讨该方法在肺外结核病中的应用价值。方法复旦大学附属公共卫生临床中心结核科2014年5月至2015年5月住院的高度疑似肺外结核患者300例,分别进行涂片荧光染色显微镜检、BACTEC MGIT 960液体培养、Xpert MTB/RIF 检测,同时所有患者均抽取全血行结核感染 T 淋巴细胞斑点试验(T-SPOT.TB)检测,分析Xpert MTB/RIF 方法对临床肺外结核标本中 MTB 及其 RIF 耐药性检测的敏感度和特异度。两独立样本的计量资料比较采用 t 检验,计数资料比较采用卡方检验。结果300例临床肺外样本,纳入282例进行统计分析,其中男性占62.7%,平均年龄为(32.1±24.6)岁,女性占37.3%,平均年龄为(37.8±21.0)岁。临床诊断肺外结核病207例(肺外结核组),非结核75例(非结核组)。以 BACTEC MGIT 960液体培养结果为诊断标准时,Xpert MTB/RIF 检测 MTB 的灵敏度为53.8%(95%CI :37.4%~69.6%),特异度为100.0%(95%CI :86.3%~100.0%),阳性预测值为100.0%(95%CI :80.8%~100.0%),阴性预测值为63.3%(95%CI :48.3%~76.2%);在荧光涂片和 BACTEC MGIT 960液体培养均为阳性的标本中,Xpert MTB/RIF 的灵敏度为92.3%(95%CI :62.1%~99.6%);在荧光涂片阴性,BACTEC MGIT 960液体培养阳性的标本中,Xpert MTB/RIF 的灵敏度为34.6%(95%CI :17.9%~55.6%)。在穿刺液、脓液、粪便及尿液中 Xpert MTB/RIF 检测具有明显优势,在浆膜腔积液及脑脊液中欠佳。BACTEC MGIT 960液体培养、荧光涂片、T-SPOT.TB 的灵敏度分别为25.8%、21.8%和70.2%,特异度分别为95.5%、90.3%和51.6Objective To detect Mycobacterium tuberculosis (MTB)and its resistance against rifampin (RIF ) by applying Xpert MTB/RIF assay in the clinical samples from patients with extrapulmonary tuberculosis,and to discuss the value of this assay in extrapulmonary tuberculosis. Methods Totally 300 clinical samples from the patients who were highly suspected with extrapulmonary tuberculosis and hospitalized in Department of Tuberculosis Section,Shanghai Public Health Clinical Center of Fudan University from May 2014 to May 2015 were collected.Smear and fluorescence staining microscopy,MGIT 960 BACTEC liquid culture,Xpert MTB/RIF assay were applied to detect MTB in these samples.Meanwhile,all the patients received the peripheral blood T-cell spot of tuberculosis test (T-SPOT.TB).The sensitivity and specificity of Xpert MTB/RIF assay for MTB and its resistance against rifampin (RIF)in extrapulmonary tuberculosis samples were evaluated.The measurement data of two independent samples were analyzed by using t test and enumeration data were analyzed by usingχ^2 test.Results Totally 282 out of 300 clinical samples from patients with extrapulmonary tuberculosis were included in this study,and 62.7% were male with average age of (32.1 ±24.6 )years and 37.3%were female with average age of (37.8 ±21 .0)years.When MGIT 960 BACTEC liquid culture results were considered as standard diagnosis,the sensitivity,specificity,positive predictive value and negative predictive value of Xpert MTB/RIF assay were 53.8% (95 %CI :37.4%—69.6%),100.0% (95 %CI :86.3%—100.0%),100.0% (95 %CI :80.8%—100.0%)and 63.3% (95 %CI :48.3%—76.2%), respectively.The sensitivity of Xpert MTB/RIF assay in smear-positive/culture-positive samples was 92.3% (95 %CI :62.1 %— 99.6%),while that in smear-negative/culture-positive samples was only 34.6% (95 %CI :17.9%— 55 .6%).Xpert MTB/RIF assay had advantage for detecting MTB in fine needle aspirates,pus,stool and urine,but not i
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