结核分枝杆菌/利福平耐药实时荧光定量核酸扩增检测技术诊断艾滋病患者肺结核的临床应用评价

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目的:探讨结核分枝杆菌(n Mycobacterium tuberculosis,MTB)/利福平耐药实时荧光定量核酸扩增检测(Xpert MTB/RIF)技术诊断艾滋病患者肺结核的应用价值。n 方法:回顾性分析2017年7月至2019年11月上海市(复旦大学附属)公共卫生临床中心收治的226例疑似肺结核的艾滋病患者的临床资料。分别进行痰涂片荧光染色显微镜下检查、BACTEC MGIT 960液体培养(或罗氏固体培养)和Xpert MTB/RIF检测,并分析在艾滋病患者中Xpert MTB/RIF技术诊断MTB感染和利福平耐药的灵敏度和特异度。结果:226例疑似肺结核患者中,痰培养阳性94例(41.6%),其中MTB阳性51例(54.3%),非结核分枝杆菌(nontuberculosis mycobacteria,NTM)阳性43例(45.7%)。以痰分枝杆菌培养阳性且结核分枝杆菌分泌蛋白64抗原阳性为金标准,Xpert MTB/RIF技术诊断MTB的灵敏度为72.6%[95%可信区间(confidence interval,n CI)66.7%~78.4%],特异度为97.1%(95%n CI 95.0%~99.3%)。Xpert MTB/RIF技术诊断痰涂片阳性患者MTB的灵敏度为76.7%(95%n CI 67.7%~85.8%),特异度为90.0%(95%n CI 83.6%~96.5%)。Xpert MTB/RIF技术诊断痰涂片阴性患者MTB的灵敏度为50.0%(95%n CI 41.8%~58.2%),特异度为99.3%(95%n CI 97.9%~100.0%)。18例患者同时检测利福平表型和基因型耐药,以表型耐药为金标准,Xpert MTB/RIF技术检测利福平基因型耐药的灵敏度为75.0%,特异度为100.0%。n 结论:艾滋病患者中Xpert MTB/RIF技术诊断肺结核的灵敏度和特异度均较高,且能快速区分MTB和NTM,具有较好的应用价值。“,”Objective:To investigate the diagnostic performance of Xpert n Mycobacterium tuberculosis/rifampin (Xpert MTB/RIF) assay for pulmonary tuberculosis (TB) in patients with acquired immunodeficiency syndrome (AIDS).n Methods:Clinical data of 226 patients with AIDS and suspected pulmonary TB in Shanghai Public Health Clinical Center, Fudan University from July 2017 to November 2019 were retrospectively analyzed. Fluorescence staining microscopy of sputum smear, BACTEC MGIT 960 liquid culture (or Roche solid culture) and Xpert MTB/RIF assay were implemented respectively. The sensitivity and specificity of Xpert MTB/RIF in the diagnosis of n Mycobacterium tuberculosis (MTB) infection and rifampin resistance were analyzed.n Results:Totally 226 patients of suspected pulmonary TB were enrolled. There were 94(41.6%) patients had positive mycobacterium culture, in which 51 (54.3%) were MTB and 43 (45.7%) were nontuberculous mycobacteria (NTM). Using the positive MTB culture of sputum and mycobacterial protein from BCG of Rm 0.64 in electrophoresis (MPB64) as reference standard, the sensitivity and specificity of Xpert MTB/RIF assay for MTB diagnosis were 72.6%(95% confidence interval (n CI) 66.7%-78.4%) and 97.1% (95%n CI 95.0%-99.3%), respectively. The sensitivity and specificity of Xpert MTB/RIF assay for MTB diagnosis in patients with positive sputum smear were 76.7%(95%n CI 67.7%-85.8%) and 90.0(95%n CI 83.6%-96.5%), respectively. The sensitivity and specificity of Xpert MTB/RIF assay for MTB diagnosis in patients with negative sputum smear were 50.0%(95%n CI 41.8%-58.2%)and 99.3%(95%n CI 97.9%-100.0%), respectively. With phenotypic resistance as reference standard, the sensitivity and specificity of Xpert MTB/RIF assay for rifampicin resistance were 75.0% and 100.0%, respectively.n Conclusion:Among AIDS patients, the performance of Xpert MTB/RIF assay for pulmonary TB diagnosis is pretty good and could differentiate MTB from NTM rapidly, which has good application value.
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