Accuracy of cell-free Mycobacterium tuberculosis DNA testing in pleural effusion for diagnosing tuberculous pleurisy: a multicenter cross-sectional study.

IF 16.7 2区医学 Q1 MEDICINE, GENERAL & INTERNAL

Military Medical Research Pub Date : 2024-08-22 DOI:10.1186/s40779-024-00567-y

Wei-Li Du, Jian-Qin Liang, Xin-Ting Yang, Cheng-Jun Li, Qing-Feng Wang, Wen-Ge Han, Ye Li, Zhi-Hui Li, Dong-Mei Zhao, Fu-Dong Xu, Yan-Xiao Rong, Xiao-Jing Cui, Hui-Min Li, Feng Wang, Peng-Chong Liu, Dong-Lin Guo, Hai-Bin Wang, Xu-Ya Xing, Jia-Lu Che, Zi-Chen Liu, Na-Na Zhang, Kun Li, Yi Liu, Li Wang, Hai-Bo Wang, Nan-Ying Che

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引用次数: 0

Abstract

Background: The diagnosis of tuberculous pleurisy (TP) presents a significant challenge due to the low bacterial load in pleural effusion (PE) samples. Cell-free Mycobacterium tuberculosis DNA (cf-TB) in PE samples is considered an optimal biomarker for diagnosing TP. This study aimed to evaluate the applicability of cf-TB testing across diverse research sites with a relatively large sample size.

Methods: Patients suspected of TP and presenting with clinical symptoms and radiological evidence of PE were consecutively enrolled by treating physicians from 11 research sites across 6 provinces in China between April 2020 and August 2022. Following centrifugation, sediments obtained from PE were used for Xpert MTB/RIF (Xpert) and mycobacterial culture, while the supernatants were subjected to cf-TB testing. This study employed a composite reference standard to definite TP, which was characterized by any positive result for Mycobacterium tuberculosis (MTB) through either PE culture, PE Xpert, or pleural biopsy.

Results: A total of 1412 participants underwent screening, and 1344 (95.2%) were subsequently enrolled in this study. Data from 1241 (92.3%) participants were included, comprising 284 with definite TP, 677 with clinically diagnosed TP, and 280 without TP. The sensitivity of cf-TB testing in definite TP was 73.6% (95% CI 68.2-78.4), significantly higher than both Xpert (40.8%, 95% CI 35.3-46.7, P < 0.001) and mycobacterial culture (54.2%, 95% CI 48.4-59.9, P < 0.001). When clinically diagnosed TP was incorporated into the composite reference standard for sensitivity analysis, cf-TB testing showed a sensitivity of 46.8% (450/961, 95% CI 43.7-50.0), significantly higher than both Xpert (116/961, 12.1%, 95% CI 10.2-14.3, P < 0.001) and mycobacterial culture (154/961, 16.0%, 95% CI 13.8-18.5, P < 0.001). The specificities of cf-TB testing, Xpert, and mycobacterial culture were all 100.0%.

Conclusions: The performance of cf-TB testing is significantly superior to that of Xpert and mycobacterial culture methods, indicating that it can be considered as the primary diagnostic approach for improving TP detection. Trial registration The trial was registered on Chictr.org.cn (ChiCTR2000031680, https://www.chictr.org.cn/showproj.html?proj=49316 ).

查看原文本刊更多论文

胸腔积液中无细胞结核分枝杆菌 DNA 检测诊断结核性胸膜炎的准确性：一项多中心横断面研究。

背景：结核性胸膜炎（TP）的诊断是一项重大挑战，因为胸腔积液（PE）样本中的细菌量较低。胸腔积液样本中的无细胞结核分枝杆菌 DNA（cf-TB）被认为是诊断结核性胸膜炎的最佳生物标志物。本研究旨在评估不同研究机构中相对较大样本量的 cf-TB 检测的适用性：方法：2020 年 4 月至 2022 年 8 月期间，中国 6 个省 11 个研究机构的主治医生连续招募了疑似 TP 患者，这些患者均有 PE 的临床症状和影像学证据。离心后，PE沉淀物用于Xpert MTB/RIF（Xpert）和分枝杆菌培养，上清液用于cf-TB检测。本研究采用综合参考标准来确定 TP，即通过 PE 培养、PE Xpert 或胸膜活检得出的结核分枝杆菌（MTB）阳性结果：共有 1412 人接受了筛查，其中 1344 人（95.2%）随后被纳入本研究。研究纳入了 1241 名参与者（92.3%）的数据，其中 284 人确诊为肺结核，677 人临床诊断为肺结核，280 人无肺结核。cf-TB 检测对确诊 TP 的灵敏度为 73.6%（95% CI 68.2-78.4），明显高于 Xpert（40.8%，95% CI 35.3-46.7，P 结论：cf-TB 检测对确诊 TP 的灵敏度为 73.6%（95% CI 68.2-78.4）：cf-TB 检测的性能明显优于 Xpert 和分枝杆菌培养方法，表明它可被视为提高 TP 检测的主要诊断方法。试验注册试验已在Chictr.org.cn注册（ChiCTR2000031680，https://www.chictr.org.cn/showproj.html?proj=49316 ）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Military Medical Research Medicine-General Medicine

CiteScore

38.40

自引率

2.80%

发文量

485

审稿时长

8 weeks

期刊介绍： Military Medical Research is an open-access, peer-reviewed journal that aims to share the most up-to-date evidence and innovative discoveries in a wide range of fields, including basic and clinical sciences, translational research, precision medicine, emerging interdisciplinary subjects, and advanced technologies. Our primary focus is on modern military medicine; however, we also encourage submissions from other related areas. This includes, but is not limited to, basic medical research with the potential for translation into practice, as well as clinical research that could impact medical care both in times of warfare and during peacetime military operations.