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Cell-free\n                      <jats:italic>Mycobacterium tuberculosis<\/jats:italic>\n                      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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      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\n                      <jats:italic>Mycobacterium tuberculosis<\/jats:italic>\n                      (MTB) through either PE culture, PE Xpert, or pleural biopsy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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\u201378.4), significantly higher than both Xpert (40.8%, 95% CI 35.3\u201346.7,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001) and mycobacterial culture (54.2%, 95% CI 48.4\u201359.9,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001). 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\u201350.0), significantly higher than both Xpert (116\/961, 12.1%, 95% CI 10.2\u201314.3,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001) and mycobacterial culture (154\/961, 16.0%, 95% CI 13.8\u201318.5,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001). The specificities of cf-TB testing, Xpert, and mycobacterial culture were all 100.0%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>\n                      <jats:italic>Trial registration<\/jats:italic>\n                      The trial was registered on Chictr.org.cn (ChiCTR2000031680,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.chictr.org.cn\/showproj.html?proj=49316\">https:\/\/www.chictr.org.cn\/showproj.html?proj=49316<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  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The study protocol and informed consent form underwent review and approval from the Institutional Review Boards (IRB) of all participating centers, encompassing both central and local IRBs as mandated by the respective sites. The ethics approval numbers of all participating centers were provided in Additional file\n                      \n                      : Table S1. In accordance with requirements, informed consent was obtained from all participants; however, for those aged 18\u00a0years or younger, legal guardians provided consent on their behalf.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"60"}}