利福平耐药实时荧光定量核酸扩增检测技术在结核病患者不同类型标本中的诊断效能评估

doi:10.19871/j.cnki.xfcrbzz.2026.04.002

摘要/Abstract

摘要： 目的本研究旨在评估利福平耐药实时荧光定量核酸扩增检测技术（GeneXpert Mycobacterium tuberculosis/rifampicin assay,Xpert MTB/RIF）在活动性结核病（tuberculosis,TB）患者不同类型临床标本中的检测效能,为结核病临床标本选择提供参考。方法采用回顾性分析方法,收集2023年1月至12月在深圳市第三人民医院确诊活动性TB患者的临床资料及各类标本Xpert MTB/RIF检测结果,统计并比较不同标本阳性检出率。对肺泡灌洗液与痰液、组织与脓液配对标本进行检出率对比分析,同时探讨初治、复治结核病患者利福平耐药发生情况。结果本研究共纳入1443份相关标本,Xpert MTB/RIF总体阳性检出率为69.02%（996/1443）。各类标本阳性检出率由高至低依次为：脓液89.11%（221/248）、肺泡灌洗液84.50%（169/200）、痰液74.74%（361/483）、组织71.42%（100/140）、尿液56.96%（45/79）、粪便42.86%（42/98）、脑脊液34.14%（28/82）及胸腔积液26.55%（30/113）。肺结核患者配对标本分析显示,肺泡灌洗液检出率（87.90%,109/124）显著高于痰液（67.74%,84/124）,差异具有统计学意义（χ²=18.939,P<0.001）。肺外结核患者配对标本分析显示,脓液检出率（86.76%,59/68）显著高于组织标本（64.71%,44/68）,差异具有统计学意义（χ²=9.000,P=0.002）。利福平耐药检测结果显示,患者总耐药率为8.59%（124/1443）,其中初治结核病患者耐药率为2.84%,复治患者耐药率为5.75%。结论 Xpert MTB/RIF检测具备快速、简便、高特异性及利福平耐药性识别优势,但不同类型标本的检出效果存在差异,临床应针对性选取标本,有助于提高病原学诊断水平。

关键词: 利福平耐药实时荧光定量核酸扩增检测技术, 结核病, 分子诊断, 利福平耐药性, 诊断效能, 联合检测

Abstract: Objective This study aimed to evaluate the diagnostic performance of the GeneXpert Mycobacterium tuberculosis/rifampicin assay (Xpert MTB/RIF), a real-time fluorescent quantitative nucleic acid amplification test, in different clinical specimens from patients with active tuberculosis (TB), so as to provide evidence for specimen selection in clinical TB diagnosis. Method A retrospective analysis was performed. Clinical data and Xpert MTB/RIF test results of various specimens were collected from patients diagnosed with active TB at the Third People's Hospital of Shenzhen between January and December 2023. The positive detection rates across specimen types were statistically compared. Paired samples of bronchoalveolar lavage fluid (BALF) versus sputum, and tissue versus pus were analyzed for detection rate differences. The prevalence of rifampicin resistance was also compared between patients with newly treated TB and retreated TB. Result A total of 1,443 specimens were enrolled. The overall positive detection rate of Xpert MTB/RIF was 69.02% (996/1443). The positive rates of different specimens sorted in descending order were as follows: pus 89.11% (221/248), bronchoalveolar lavage fluid 84.50% (169/200), sputum 74.74% (361/483), tissue 71.42% (100/140), urine 56.96% (45/79), stool 42.86% (42/98), cerebrospinal fluid 34.14% (28/82), and pleural effusion 26.55% (30/113). Paired analysis for pulmonary TB patients revealed that the detection rate of BALF (87.90%, 109/124) was significantly higher than that of sputum (67.74%, 84/124), with a statistically significant difference (χ²=18.939,P<0.001). For extrapulmonary TB patients, the detection rate of pus (86.76%, 59/68) was markedly higher than that of tissue specimens (64.71%, 44/68) (χ²=9.000, P=0.002). Rifampicin resistance testing showed an overall resistance rate of 8.59% (124/1443), including a resistance rate of 2.84% in newly treated TB patients and 5.75% in retreated TB patients. Conclusion Xpert MTB/RIF assay features rapid detection, simple operation, high specificity, and the capability to identify rifampicin resistance. However, its diagnostic yield varies substantially by specimen type. Targeted selection of clinical specimens can effectively improve the etiological diagnostic accuracy of tuberculosis.

Key words: Xpert MTB/RIF, Tuberculosis, Molecular diagnosis, Rifampicin resistance, Diagnostic efficiency, Paired detection

中图分类号:

R446

张雅曦, 李静, 杨倩婷, 王敏, 詹森林, 陈骑. 利福平耐药实时荧光定量核酸扩增检测技术在结核病患者不同类型标本中的诊断效能评估[J]. 新发传染病电子杂志, 2026, 11(4): 13-17.

Zhang Yaxi, Li Jing, Yang Qianting, Wang Min, Zhan Senlin, Chen Qi. The diagnostic value of Xpert MTB/RIF detection in different types of samples of tuberculosis patients[J]. Electronic Journal of Emerging Infectious Diseases, 2026, 11(4): 13-17.

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