{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T16:06:43Z","timestamp":1753891603739,"version":"3.41.2"},"reference-count":21,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:00:00Z","timestamp":1747180800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Microbiol."],"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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%, <jats:italic>p<\/jats:italic> &amp;lt; 0.001). Of the 18 bacteriologically confirmed PTB, equal sensitivity (94.44%) was observed between Xpert and AutoSAT. The higher specificity of AutoSAT than Xpert (100% vs. 96.30%, <jats:italic>p\u202f=<\/jats:italic> 0.803) was observed among PTB. The higher sensitivity of AutoSAT than Xpert was observed among confirmed EPTB (22.07% vs. 18.62%, <jats:italic>p<\/jats:italic> &amp;lt; 0.001) and bacteriologically confirmed EPTB patients (92.31% vs. 84.62%, <jats:italic>p<\/jats:italic>\u202f=\u202f0.53), but the specificity (100%) was equal. And AutoSAT yielded higher sensitivity on pleural fluid (14.91% vs. 9.65%, <jats:italic>p<\/jats:italic>\u202f=\u202f0.276). The same specificities (100%) were observed on different types of specimens.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>AutoSAT is an accurate, sensitive and rapid method for the detection of Mycobacterium tuberculosis in both PTB and EPTB patients. AutoSAT is highly effective in bacteriologically confirmed PTB, and outperforms Xpert in paucibacillary EPTB patients, especially for pleural fluid specimen detection.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmicb.2025.1590635","type":"journal-article","created":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T21:14:01Z","timestamp":1747257241000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Diagnostic value of a novel automated simultaneous amplification and testing method in pulmonary tuberculosis and extrapulmonary tuberculosis"],"prefix":"10.3389","volume":"16","author":[{"given":"Xichao","family":"Ou","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peilei","family":"Hu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xundi","family":"Bao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhou","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chong","family":"Teng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jingwei","family":"Guo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dongfang","family":"Xu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yue","family":"Li","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bing","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruida","family":"Xing","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hui","family":"Xia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ling","family":"Ma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuanyuan","family":"Song","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shengfen","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanlin","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yunhong","family":"Tan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huiwen","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2025,5,14]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"e00812-17","DOI":"10.1128\/mBio.00812-17","article-title":"The new Xpert MTB\/RIF ultra: improving detection of and resistance to rifampin in an assay suitable for point-of-care testing","volume":"8","author":"Chakravorty","year":"2017","journal-title":"MBio"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"498","DOI":"10.1136\/jclinpath-2017-204714","article-title":"Rapid diagnosis of pulmonary tuberculosis and detection of drug resistance by combined simultaneous amplification testing and reverse dot blot","volume":"71","author":"Chen","year":"2018","journal-title":"J. Clin. Pathol."},{"key":"ref3","doi-asserted-by":"publisher","first-page":"646","DOI":"10.1128\/JCM.05853-11","article-title":"Novel real-time simultaneous amplification and testing method to accurately and rapidly detect complex","volume":"50","author":"Cui","year":"2012","journal-title":"J. Clin. Microbiol."},{"key":"ref4","doi-asserted-by":"publisher","first-page":"1863","DOI":"10.3760\/cma.j.issn.0366-6999.20133010","article-title":"Clinical diagnostic performance of the simultaneous amplification and testing methods for detection of the complex for smear-negative or sputum-scarce pulmonary tuberculosis in China","volume":"127","author":"Fan","year":"2014","journal-title":"Chin. Med. J."},{"key":"ref5","doi-asserted-by":"publisher","first-page":"783","DOI":"10.1136\/thx.2005.054908","article-title":"Current evidence on diagnostic accuracy of commercially based nucleic acid amplification tests for the diagnosis of pulmonary tuberculosis","volume":"61","author":"Greco","year":"2006","journal-title":"Thorax"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"314","DOI":"10.1128\/JCM.01313-07","article-title":"Specimen dilution improves sensitivity of the amplified direct test for smear microscopy-positive respiratory specimens","volume":"46","author":"Guerra","year":"2008","journal-title":"J. Clin. Microbiol."},{"key":"ref7","doi-asserted-by":"publisher","first-page":"2410","DOI":"10.1128\/jcm.31.9.2410-2416.1993","article-title":"Detection and identification of Mycobacterium-tuberculosis directly from sputum sediments by amplification of rRNA","volume":"31","author":"Jonas","year":"1993","journal-title":"J. Clin. Microbiol."},{"key":"ref8","doi-asserted-by":"publisher","first-page":"303","DOI":"10.1186\/s12879-020-05036-0","article-title":"Application of real-time simultaneous amplification and testing method to accurately and rapidly detect extra-pulmonary tuberculosis","volume":"20","author":"Li","year":"2020","journal-title":"BMC Infect. Dis."},{"key":"ref9","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1016\/j.ijid.2022.12.005","article-title":"Extrapulmonary tuberculosis in China: a national survey","volume":"128","author":"Li","year":"2023","journal-title":"Int. J. Infect. Dis."},{"key":"ref10","doi-asserted-by":"publisher","first-page":"1601075","DOI":"10.1183\/13993003.01075-2016","article-title":"Accuracy of line probe assays for the diagnosis of pulmonary and multidrug-resistant tuberculosis: a systematic review and meta-analysis","volume":"49","author":"Nathavitharana","year":"2017","journal-title":"Eur. Respir. J."},{"key":"ref11","doi-asserted-by":"publisher","first-page":"633","DOI":"10.1586\/14787210.2014.899900","article-title":"Challenges and perspectives in the diagnosis of extrapulmonary tuberculosis","volume":"12","author":"Norbis","year":"2014","journal-title":"Expert Rev. Anti Infect. Ther."},{"key":"ref12","doi-asserted-by":"publisher","first-page":"2853","DOI":"10.1128\/JCM.36.10.2853-2860.1998","article-title":"Clinical evaluation of the automated COBAS AMPLICOR MTB assay for testing respiratory and nonrespiratory specimens","volume":"36","author":"Reischl","year":"1998","journal-title":"J. Clin. Microbiol."},{"key":"ref13","first-page":"39","article-title":"Clinical applications of molecular biology for infectious diseases","volume":"27","author":"Speers","year":"2006","journal-title":"Clin. Biochem. Rev."},{"volume-title":"Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB","year":"2013","key":"ref14"},{"volume-title":"Molecular assays intended as initial tests for the diagnosis of pulmonary and extrapulmonary TB and rifampicin resistance in adults and children: rapid communication","year":"2020","key":"ref15"},{"volume-title":"WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis\u2013rapid diagnostics for tuberculosis detection, 2021 update","year":"2021","key":"ref16"},{"first-page":"2024","volume-title":"Global Tuberculosis Report","year":"2024","key":"ref17"},{"volume-title":"Definitions and reporting framework for tuberculosis - 2013 revision (updated December 2014 and January 2020)","year":"2020","key":"ref18"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"e2597","DOI":"10.1097\/MD.0000000000002597","article-title":"A large cohort study on the clinical value of simultaneous amplification and testing for the diagnosis of pulmonary tuberculosis","volume":"95","author":"Yan","year":"2016","journal-title":"Medicine"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"17","DOI":"10.1186\/s12879-017-2647-7","article-title":"Clinical diagnostic value of simultaneous amplification and testing for the diagnosis of sputum-scarce pulmonary tuberculosis","volume":"17","author":"Yan","year":"2017","journal-title":"BMC Infect. Dis."},{"key":"ref21","doi-asserted-by":"publisher","first-page":"86","DOI":"10.1016\/j.jiac.2013.07.003","article-title":"Rapid and effective diagnosis of pulmonary tuberculosis with novel and sensitive loop-mediated isothermal amplification (LAMP) assay in clinical samples: a meta-analysis","volume":"20","author":"Yuan","year":"2014","journal-title":"J. Infect. Chemother."}],"container-title":["Frontiers in Microbiology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmicb.2025.1590635\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,20]],"date-time":"2025-05-20T10:38:41Z","timestamp":1747737521000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmicb.2025.1590635\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,14]]},"references-count":21,"alternative-id":["10.3389\/fmicb.2025.1590635"],"URL":"https:\/\/doi.org\/10.3389\/fmicb.2025.1590635","relation":{},"ISSN":["1664-302X"],"issn-type":[{"type":"electronic","value":"1664-302X"}],"subject":[],"published":{"date-parts":[[2025,5,14]]},"article-number":"1590635"}}