首页 > 军事医学研究（英文版） > Accuracy of cell-free Mycobacterium tuberculosis DNA testing in pleural effusion for diagnosing tuberculous pleurisy:a multicenter cross-sectional study

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

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摘要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(12.1%,116/961,95%CI 10.2%-14.3%,P<0.001)and mycobacterial culture(16.0%,154/961,95%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).

作者 Wei-Li Du ^[1] Jian-Qin Liang ^[2] Xin-Ting Yang ^[3] Cheng-Jun Li ^[4] Qing-Feng Wang ^[3] Wen-Ge Han ^[5] Ye Li ^[6] Zhi-Hui Li ^[7] Dong-Mei Zhao ^[8] Fu-Dong Xu ^[1] Yan-Xiao Rong ^[9] Xiao-Jing Cui ^[10] Hui-Min Li ^[11] Feng Wang ^[12] Peng-Chong Liu ^[7] Dong-Lin Guo ^[2] Hai-Bin Wang ^[9] Xu-Ya Xing ^[1] Jia-Lu Che ^[1] Zi-Chen Liu ^[1] Na-Na Zhang ^[1] Kun Li ^[1] Yi Liu ^[13] Li Wang ^[14] Hai-Bo Wang ^[15] Nan-Ying Che ^[1] 学术成果认领

作者单位 Department of Pathology,Beijing Key Laboratory for Drug Resistant Tuberculosis Research,Beijing Chest Hospital,Capital Medical University,Beijing Tuberculosis and Thoracic Tumor Research Institute,Beijing 101149,China ^[1] Senior Department of Tuberculosis,the Eighth Medical Center of Chinese PLA General Hospital,Beijing 100091,China ^[2] Department of Tuberculosis,Beijing Chest Hospital,Capital Medical University,Beijing Tuberculosis and Thoracic Tumor Research Institute,Beijing 101149,China ^[3] Department of Tuberculosis,Shenyang Tenth People's Hospital,Shenyang Chest Hospital,Shenyang 110044,China ^[4] Department of Tuberculosis,Second People's Hospital of Weifang,Weifang 261041,Shandong,China ^[5] Tuberculosis Department I,Anhui Chest Hospital,Anhui 230022,China ^[6] Department of Tuberculosis,Hebei Chest Hospital,Shijiazhuang 050041,China ^[7] Department of Tuberculosis,the Infectious Disease Hospital of Heilongjiang Province,Harbin 150500,China ^[8] Department of Tuberculosis,the Fifth Hospital of Shijiazhuang,Shijiazhuang 050021,China ^[9] Department of Pulmonary and Critical Care Medicine,China Center of Respiratory Medicine,National Clinical Research Center for Respiratory Diseases,China-Japan Friendship Hospital,Institute of Respiratory Medicine,Chinese Academy of Medical Sciences,Peking Union Medical College,Beijing 100029,China ^[10] Department of Respiratory Medicine,National Clinical Research Center of Respiratory Disease,National Center for Children's Health,Beijing Children's Hospital,Capital Medical University,Beijing 100045,China ^[11] Department of Respiratory and Critical Care Medicine,Beijing Institute of Respiratory Medicine,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China ^[12] Biobank of Beijing Chest Hospital,Capital Medical University,Beijing Tuberculosis and Thoracic Tumor Research Institute,Beijing 101149,China ^[13] Beijing Western Medical Branch of PLA General Hospital,Beijing 100091,China ^[14] Clinical Research Institute,Institute of Advanced Clinical Medicine,Peking University;Key Laboratory of Epidemiology of Major Diseases(Peking University),Ministry of Education,Beijing 100191,China ^[15]

关键词 Cell-free Mycobacterium tuberculosis DNA(cf-TB)Pleural effusion(PE)Tuberculous pleurisy(TP)Diagnosis

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RESEARCH

DOI 10.1186/s40779-024-00567-y

发布时间 2025-09-02（万方平台首次上网日期，不代表论文的发表时间）

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