1. Accuracy of cell-free Mycobacterium tuberculosis DNA testing in pleural effusion for diagnosing tuberculous pleurisy: a multicenter cross-sectional study
- Author
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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, and Nan-Ying Che
- Subjects
Cell-free Mycobacterium tuberculosis DNA (cf-TB) ,Pleural effusion (PE) ,Tuberculous pleurisy (TP) ,Diagnosis ,Medicine (General) ,R5-920 ,Military Science - Abstract
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
- Published
- 2024
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