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| 靶向测序在涂片阴性或无痰分枝杆菌病中的诊断价值 |
| The diagnostic value of targeted next-generation sequencing in smear-negative or sputum-scarce mycobacterial disease |
| 投稿时间：2026-01-06 |
| DOI：10.3969/j.issn.1000-0399.2026.08.002 |
| 中文关键词: 靶向测序 分枝杆菌病 肺结核 非结核分枝杆菌肺病 |
| 英文关键词: Targeted next-generation sequencing Mycobacterial disease Pulmonary tuberculosis Non-tuberculous mycobacterial pulmonary disease |
| 基金项目:安徽省自然科学基金项目(编号:2208085MH193) |
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| 中文摘要: |
| 目的 评估靶向测序（tNGS）在不同临床标本中的诊断效能，并与荧光聚合酶链式反应熔解曲线（MCA）和分枝杆菌培养进行比较。方法 回顾性分析2023年1月至2025年7月安徽省胸科医院收治的167例疑似肺结核或非结核分枝杆菌肺病患者的临床资料，所有患者均为痰涂片阴性或无痰病例。采集的临床标本包括痰液9份、支气管肺泡灌洗液（BALF）129份及胸腔积液29份。对同一标本同步进行tNGS、MCA和分枝杆菌培养检测。以根据行业标准和指南制定的复合参考标准（CRS）为参照，通过灵敏度、特异度、准确度评价各方法的诊断效能。结果 在BALF标本中，tNGS的灵敏度（81.19%）和准确度（83.72%）均高于MCA(24.75%,40.31%)和分枝杆菌培养（36.63%,50.39%）(P<0.001)。在胸腔积液标本中，同样观察到tNGS的灵敏度（58.33%）和准确度（65.52%）优于MCA(16.67%,31.03%)（灵敏度P=0.006，准确度P=0.006）和分枝杆菌培养（25.00%,37.93%）（灵敏度P=0.021，准确度P=0.021）。结论 以CRS为参照，tNGS在涂片阴性或无痰疑似分枝杆菌病患者的BALF标本中表现出较高的灵敏度和准确度；在胸腔积液标本中亦显示一定诊断价值。 |
| 英文摘要: |
| Objective To evaluate the diagnostic performance of targeted next-generation sequencing(tNGS) across different clinical specimens and compare it with fluorescence polymerase chain reaction melting curve analysis(MCA) and mycobacterial culture. Methods This retrospective study analyzed the clinical data of 167 patients with suspected pulmonary tuberculosis(PTB) or non-tuberculous mycobacterial(NTM) lung disease admitted to Anhui Chest Hospital from January 2023 to July 2025. All patients were either smear-negative or sputum-scarce. Clinical specimens included 9 sputum specimens, 129 bronchoalveolar lavage fluid(BALF) specimens, and 29 pleural effusion specimens. Each specimen was simultaneously subjected to tNGS, MCA, and mycobacterial culture. The composite reference standard(CRS), established according to industry standards and guidelines, was used for diagnostic evaluation. Diagnostic efficacy was evaluated by sensitivity, specificity, and accuracy. Results In BALF specimens, the sensitivity and accuracy of tNGS(81.19% and 83.72%, respectively) were significantly higher than those of MCA(24.75% and 40.31%, respectively) and mycobacterial culture(36.63% and 50.39%, respectively)(P<0.001). In pleural effusion specimens, the sensitivity and accuracy of tNGS(58.33% and 65.52%, respectively) were significantly higher than those of MCA(16.67% and 31.03%, respectively)(sensitivity P=0.006, accuracy P=0.006) and mycobacterial culture(25.00% and 37.93%, respectively)(sensitivity P=0.021, accuracy P=0.021). Conclusions With CRS as the reference, tNGS demonstrates high sensitivity and accuracy in BALF specimens from smear-negative or sputum-scarce patients with suspected mycobacterial disease, and shows certain diagnostic value in pleural effusion specimens. These results suggest that tNGS can serve as an important supplementary tool to conventional detection methods, improving the etiological detection capability of mycobacterial disease in smear-negative or sputum-scarce patients. |
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