ORIGINAL RESEARCH article
Front. Microbiol.
Sec. Infectious Agents and Disease
Volume 16 - 2025 | doi: 10.3389/fmicb.2025.1590635
This article is part of the Research TopicRapid and Efficient Analytical Technologies for Pathogen DetectionView all articles
Diagnostic value of a novel automated simultaneous amplification and testing method in pulmonary tuberculosis and extrapulmonary tuberculosis
Provisionally accepted
Xichao Ou1
Peilei Hu2
Xundi Bao3
Zhou Liu3Chong Teng4Jingwei Guo2Dongfang Xu3Yue Li3Bing Zhao1
Ruida Xing1
Hui Xia1Ling Ma5
Yang Zhou1Yang Zheng1Yuanyuan Song1
Shengfen Wang1
Yanlin Zhao1Yunhong Tan2
Huiwen Zheng6*- 1Chinese Center For Disease Control and Prevention, Beijing, China
- 2Hunan Chest Hospital, Changsha, Anhui Province, China
- 3Anhui Chest Hospital, Hefei, Anhui Province, China
- 4Dongcheng Center for Disease Control and Prevention, Beijing, China
- 5Gansu Centre for Disease Control and Prevention, Lanzhou, Gansu Province, China
- 6Beijing Children’s Hospital, Capital Medical University, Beijing, China
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Objective: To evaluate the clinical diagnostic ability of automated simultaneous amplification and testing (AutoSAT) method in suspected pulmonary tuberculosis (PTB) and extrapulmonary tuberculosis (EPTB) by comparing with Xpert MTB/RIF (Xpert) method against the composite reference standard.Method: Patients with suspected PTB or EPTB were enrolled consecutively from two provincial tuberculosis designated hospitals between August 2022 and December 2023. Clinical specimens were collected for routine clinical tests and AutoSAT.The 297 patients including 90 PTB suspects and 207 EPTB suspects were eligible for final analysis. Among the 63 confirmed PTB, the sensitivity of Xpert was significantly higher than that of AutoSAT (30.16% vs 28.57%, P ＜ 0.001). Of the 18 bacteriologically confirmed PTB, equal sensitivity (94.44%) was observed between Xpert and AutoSAT. The higher specificities of AutoSAT than Xpert (100% vs 96.30%, P = 0.803) was observed among PTB. The higher sensitivity of AutoSAT than Xpert was observed among confirmed EPTB (22.07% vs 18.62%, P ＜ 0.001) and bacteriologically confirmed EPTB patients (92.31% vs 84.62%, P = 0.53), but the specificity (100%) was equal. And AutoSAT yielded higher sensitivity on pleural fluid (14.91% vs 9.65%, P = 0.276). The same specificities (100%) were observed on different types of specimens.AutoSAT is an accurate, sensitive and rapid method for the detection of MTB in both TB and EPTB patients. AutoSAT is highly effective in bacteriologically confirmed PTB, and outperforms Xpert in paucibacillary EPTB patients, especially for pleural fluid specimen detection.
Keywords: pulmonary tuberculosis, Extrapulmonary tuberculosis, AutoSAT, diagnosis, Xpert MTB/RIF
Received: 10 Mar 2025; Accepted: 14 Apr 2025.
Copyright: © 2025 Ou, Hu, Bao, Liu, Teng, Guo, Xu, Li, Zhao, Xing, Xia, Ma, Zhou, Zheng, Song, Wang, Zhao, Tan and Zheng. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Huiwen Zheng, Beijing Children’s Hospital, Capital Medical University, Beijing, China
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