肺结核(PTB)的及时诊断仍然是临床实践中的挑战。本研究旨在优化在现实环境中快速诊断PTB的算法。
回顾性分析了中国28,171例疑似患有PTB的成人住院患者。支气管肺泡灌洗液(BALF)和/或痰用于抗酸杆菌(AFB)涂片,XpertMTB/RIF(Xpert),和文化。阳性分枝杆菌培养物用作参考标准。外周血单核细胞(PBMC)用于T-SPOT。TB。我们分析了样本类型对这些检测性能的影响,确定诊断PTB的涂片数量,并评估了这些单独进行的检测的能力,或组合,诊断PTB和非结核分枝杆菌(NTM)感染。
当用于AFB涂片或Xpert时,痰和BALF显示中等至基本的一致性,BALF阳性检出率较高。3-4个涂片比1-2个涂片具有更高的灵敏度。此外,AFB和Xpert的同时组合正确识别出AFB/Xpert+的44/51和AFB/Xpert-病例的6/7为PTB和NTM,分别。最后,当与AFB/Xpert顺序组合时,T-SPOT在AFB+或Xpert+患者中的作用有限。然而,T-SPOTMDC(制造商定义的截止值)显示出较高的负预测值(99.1%)和次优灵敏度(74.4%),和TBAg/PHA(结核分枝杆菌特异性抗原与植物血凝素斑点形成细胞的比率,这是一种计算T-SPOT的改进方法。TB测定结果)≥0.3在AFB-/Xpert-患者中表现出高特异性(95.7%)和相对较低的敏感性(16.3%)。
同时对痰液和/或BALF进行AFB涂片(至少3次涂片)和Xpert可以帮助在现实世界的高负担环境中快速诊断PTB和NTM感染。如果可用,BALF对于AFB涂片和Xpert都是优选的。扩展这个算法,PBMCT-SPOTMDC和TBAg/PHA比率对AFB-/Xpert-患者的PTB诊断具有补充作用(适度排除PTB并在PTB中裁定,分别)。我们的研究结果也可能为决策者在高负担环境下预防和控制结核病的决策提供信息。
The prompt diagnosis of pulmonary tuberculosis (PTB) remains a challenge in clinical practice. The present study aimed to optimize an algorithm for rapid diagnosis of PTB in a real-world setting.
28,171 adult inpatients suspected of having PTB in
China were retrospectively analyzed. Bronchoalveolar lavage fluid (BALF) and/or sputum were used for acid-fast bacilli (AFB) smear, Xpert MTB/RIF (Xpert), and culture. A positive mycobacterial culture was used as the reference standard. Peripheral blood mononuclear cells (PBMC) were used for T-SPOT.TB. We analyzed specimen types\' effect on these assays\' performance, determined the number of smears for diagnosing PTB, and evaluated the ability of these assays performed alone, or in combination, to diagnose PTB and nontuberculous mycobacteria (NTM) infections.
Sputum and BALF showed moderate to substantial consistency when they were used for AFB smear or Xpert, with a higher positive detection rate by BALF. 3-4 smears had a higher sensitivity than 1-2 smears. Moreover, simultaneous combination of AFB and Xpert correctly identified 44/51 of AFB+/Xpert+ and 6/7 of AFB+/Xpert- cases as PTB and NTM, respectively. Lastly, when combined with AFB/Xpert sequentially, T-SPOT showed limited roles in patients that were either AFB+ or Xpert+. However, T-SPOTMDC (manufacturer-defined cut-off) showed a high negative predicative value (99.1%) and suboptimal sensitivity (74.4%), and TBAg/PHA (ratio of Mycobacterium tuberculosis-specific antigens to phytohaemagglutinin spot-forming cells, which is a modified method calculating T-SPOT.TB assay results) ≥0.3 demonstrated a high specificity (95.7%) and a relatively low sensitivity (16.3%) in AFB-/Xpert- patients.
Concurrently performing AFB smear (at least 3 smears) and Xpert on sputum and/or BALF could aid in rapid diagnosis of PTB and NTM infections in a real-world high-burden setting. If available, BALF is preferred for both AFB smear and Xpert. Expanding this algorithm, PBMC T-SPOTMDC and TBAg/PHA ratios have a supplementary role for PTB diagnosis in AFB-/Xpert- patients (moderately ruling out PTB and ruling in PTB, respectively). Our findings may also inform policy makers\' decisions regarding prevention and control of TB in a high burden setting.