{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T09:50:19Z","timestamp":1791798619179,"version":"4.3.4"},"reference-count":30,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T00:00:00Z","timestamp":1791763200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T00:00:00Z","timestamp":1791763200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"abstract":"ABSTRACT<\/jats:title>\n \n Background<\/jats:title>\n \n Molecular assays are essential for the rapid detection of\n \n Mycobacterium tuberculosis<\/jats:italic>\n <\/jats:styled-content>\n complex (MTBC). However, head\u2010to\u2010head comparisons of widely used commercial assays remain limited. This study compared the diagnostic performance of three real\u2010time PCR assays\u2014AdvanSure TB\/NTM, Cobas MTB, and Xpert MTB\/RIF\u2014using bronchial washing specimens.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We retrospectively analyzed molecular assay results from 3348 bronchial washing specimens obtained between January 2021 and May 2024. Among them, 740 specimens were included in a head\u2010to\u2010head comparison of the three assays. Diagnostic performance was evaluated using culture\u2010confirmed MTBC as the reference standard.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n In the head\u2010to\u2010head comparison (\n n<\/jats:italic>\n \u2009=\u2009740), the overall concordance rate was 93.6%. Using culture\u2010confirmed MTBC as the reference standard, the sensitivities of the AdvanSure, Cobas, and Xpert assays were 49.1%, 96.2%, and 90.6%, respectively. In smear\u2010negative cases (\n n<\/jats:italic>\n \u2009=\u2009713), AdvanSure showed markedly lower sensitivity (30.8%) than the Cobas (94.9%) and Xpert (87.2%). AdvanSure showed the highest overall specificity (98.7%), followed by Cobas (96.9%) and Xpert (96.4%). The Xpert MTB\/RIF assay demonstrated complete concordance with drug susceptibility testing for detecting rifampicin resistance, with a sensitivity of 100% (95% CI, 59.0%\u2013100.0%) and a specificity of 100% (95% CI, 97.3%\u2013100.0%).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n In this real\u2010world cohort with a high proportion of smear\u2010negative cases, the Cobas and Xpert assays exhibited significantly higher sensitivity for MTBC detection than the AdvanSure assay. These findings highlight the importance of highly sensitive molecular assays for the early diagnosis of pulmonary tuberculosis, particularly in patients with low bacillary burden.<\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/jcla.70380","type":"journal-article","created":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T09:33:51Z","timestamp":1791797631000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative Diagnostic Performance of Three Commercial Real\u2010Time\n PCR<\/scp>\n Assays for the Detection of\n \n Mycobacterium tuberculosis<\/i>\n <\/scp>\n Complex in Bronchial Washing Specimens: A Large Retrospective Study"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0530-3425","authenticated-orcid":false,"given":"Jimyung","family":"Kim","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine Chungnam National University Hospital Daejeon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4753-9161","authenticated-orcid":false,"given":"Yumi","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Chungnam National University Hospital Daejeon Republic of Korea"},{"name":"Department of Laboratory Medicine, College of Medicine Chungnam National University Daejeon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,12]]},"reference":[{"key":"e_1_2_11_2_1","volume-title":"Global Tuberculosis Report 2025","author":"World Health Organization","year":"2025"},{"key":"e_1_2_11_3_1","first-page":"401","volume-title":"Tuberculosis 2007: From Basic Science to Patient Care","author":"Waard J. 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A.","year":"2012","journal-title":"BMC Infectious Diseases"},{"issue":"1","key":"e_1_2_11_10_1","first-page":"35","article-title":"The Value of Bronchoalveolar Lavage in the Diagnosis of Sputum Smear\u2010Negative Pulmonary Tuberculosis","volume":"10","author":"Nikbakhsh N.","year":"2015","journal-title":"Iranian Journal of Pathology"},{"issue":"1","key":"e_1_2_11_11_1","doi-asserted-by":"crossref","first-page":"15","DOI":"10.3390\/arm92010003","article-title":"The Added Value of Bronchoalveolar Lavage for Pulmonary Tuberculosis Diagnosis in High\u2010Risk Hospitalized Patients With Negative Sputum Samples","volume":"92","author":"Freund O.","year":"2024","journal-title":"Advances in Respiratory Medicine"},{"issue":"1","key":"e_1_2_11_12_1","first-page":"33","article-title":"Outcome of Fiber Optic Bronchoscopy in Sputum Smear\u2010Negative Pulmonary Tuberculosis","volume":"5","author":"Choudhary S.","year":"2015","journal-title":"Panacea Journal of Medical Science"},{"key":"e_1_2_11_13_1","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2466-14-137","article-title":"Retrospective Observational Study of Diagnostic Accuracy of the Xpert MTB\/RIF Assay on Fiberoptic Bronchoscopy Sampling for Early Diagnosis of Smear\u2010Negative or Sputum\u2010Scarce Patients With Suspected Tuberculosis","volume":"14","author":"Le Palud P.","year":"2014","journal-title":"BMC Pulmonary Medicine"},{"issue":"3","key":"e_1_2_11_14_1","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1007\/s12055-018-0645-z","article-title":"Role of Flexible Bronchoscopy in Patients With Sputum\u2010Negative Pulmonary Tuberculosis","volume":"34","author":"Sanjeevaiah S.","year":"2018","journal-title":"Indian Journal of Thoracic Cardiovascular Surgery"},{"issue":"3","key":"e_1_2_11_15_1","first-page":"327","article-title":"Comparison of the Xpert MTB\/RIF Assay and Real\u2010Time PCR for the Detection of \n Mycobacterium tuberculosis","volume":"45","author":"Kim M. 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C.","year":"2025","journal-title":"International Journal of Antimicrobial Agents"},{"issue":"1","key":"e_1_2_11_23_1","doi-asserted-by":"crossref","first-page":"89","DOI":"10.4046\/trd.2021.0100","article-title":"Head\u2010To\u2010Head Comparison Between Xpert MTB\/RIF Assay and Real\u2010Time Polymerase Chain Reaction Assay Using Bronchial Washing Specimens for Tuberculosis Diagnosis","volume":"85","author":"Son E.","year":"2022","journal-title":"Tuberculosis Respiratory Disease"},{"issue":"1","key":"e_1_2_11_24_1","doi-asserted-by":"crossref","first-page":"115","DOI":"10.5588\/ijtld.15.0227","article-title":"Accuracy of Xpert MTB\/RIF Assay Compared With AdvanSure TB\/NTM Real\u2010Time PCR Using Bronchoscopy Specimens","volume":"20","author":"Ko Y.","year":"2016","journal-title":"International Journal of Tuberculosis and Lung Disease"},{"issue":"6","key":"e_1_2_11_25_1","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pntd.0011403","article-title":"Evaluation of Xpert MTB\/RIF Assay for the Diagnosis of Extrapulmonary Tuberculosis in Southwest China","volume":"17","author":"Li T. 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