{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T13:07:50Z","timestamp":1788959270742,"version":"build-2803163510"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Universitat de Valencia"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Clin Microbiol Infect Dis"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>\n                      We evaluated the performance of the Abbott RealTi\n                      <jats:italic>me Mycobacterium tuberculosis<\/jats:italic>\n                      (MTB) PCR (RT MTB) on bronchoscopic specimens using conventional culture as the reference standard in a low\u2013Tuberculosis (TB) prevalence setting.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      A total of 6,988 specimens (4,682 bronchial aspirates [BAS] and 2,306 bronchoalveolar lavages [BAL]) from 4,118 patients with suspected pulmonary TB were included. When BAS and BAL specimens from the same bronchoscopy procedure were available, these were mixed 1:1 prior to culture inoculation and PCR testing. Following processing, specimens were inoculated into a L\u00f6wenstein-Jensen and a Bactec MGIT 960 tube and incubated at 37\u00a0\u00b0C for 3 months and at 35\u00a0\u00b0C for 8 weeks, respectively. RT MTB was performed as indicated by the manufacturer. RT MTB targets the insertion sequence IS\n                      <jats:italic>6110<\/jats:italic>\n                      and the protein antigen B (PAB) gene, both highly conserved within the\n                      <jats:italic>Mycobacterium tuberculosis<\/jats:italic>\n                      complex. Whole genome Next generation sequencing of clinical MTBC isolates was performed when indicated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among the 104 culture-positive specimens, 84 (1.2%) were detected by PCR. Additionally, 16 specimens (0.3% of all samples), from 16 patients, were PCR-positive despite negative culture results. Conversely, 20 specimens (0.4% of all samples), from 19 patients, were culture-positive but not detected by PCR. No significant differences were found between PCR-positive and PCR-negative specimens with respect to the number of IS\n                      <jats:italic>6110<\/jats:italic>\n                      copies per isolate or PAB gene sequences (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.69). Finally, there were 4,683 specimens (97.4%) from the remaining 4,014 patients tested PCR-negative\/Culture-negative. Following the resolution of discrepancies based on clinical grounds the sensitivity and specificity of RT MTB were 83.9% (CI 95%, 76.0\u201390.0) and 99.9% (CI 95%, 99.9\u201399.9), respectively. These results exceed the minimum performance requirements defined in the WHO Target Product Profiles for molecular TB diagnostics. Although RT MTB is not a point-of-care test but rather a moderate-complexity automated NAAT, it is recommended by WHO as part of the Abbott RealTime MTB\/MTB RIF-INH testing algorithm, in which MTBC detection by RT MTB is followed by reflex testing with the MTB RIF\/INH assay for detection of rifampicin and isoniazid resistance.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>RT MTB shows a good performance on bronchoscopic specimens.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10096-026-05652-9","type":"journal-article","created":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T12:32:02Z","timestamp":1788957122000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Clinical performance of the Abbott RealTime Mycobacterium tuberculosis (MTB) PCR on bronchoscopic specimens for diagnosing pulmonary tuberculosis"],"prefix":"10.1007","author":[{"given":"Juan Jos\u00e9","family":"Ripoll","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda \u00c1ngeles","family":"Clari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nieves","family":"Orta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rabab","family":"Chouman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaime","family":"Signes-Costa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9","family":"Franco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla","family":"Mariner-Llicer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariana L\u00f3pez","family":"MG","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I\u00f1aki","family":"Comas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Navarro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,9,9]]},"reference":[{"key":"5652_CR1","doi-asserted-by":"publisher","unstructured":"Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, Keane J, Lewinsohn DA, Loeffler AM, Mazurek GH, O'Brien RJ, Pai M, Richeldi L, Salfinger M, Shinnick TM, Sterling TR, Warshauer DM, Woods GL (2017) Official American Thoracic Society\/Infectious Diseases Society of America\/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Infect Dis 64:111-115. https:\/\/doi.org\/10.1093\/cid\/ciw778","DOI":"10.1093\/cid\/ciw778"},{"key":"5652_CR2","unstructured":"WHO (2024) consolidated guidelines on tuberculosis Module 3: diagnosis \u2013 rapid diagnostics for tuberculosis detection, third edition. World Health Organization, Geneva, licence (CC BY-NC-SA 3.0 IGO. https:\/\/creativecommons.org\/licenses\/by-nc-sa\/3.0\/igo )"},{"key":"5652_CR3","doi-asserted-by":"publisher","first-page":"e00812","DOI":"10.1128\/mBio.00812-17","volume":"8","author":"S Chakravorty","year":"2017","unstructured":"Chakravorty S, Simmons AM, Rowneki M, Parmar H, Cao Y, Ryan J, Banada PP, Deshpande S, Shenai S, Gall A, Glass J, Krieswirth B, Schumacher SG, Nabeta P, Tukvadze N, Rodrigues C, Skrahina A, Tagliani E, Cirillo DM, Davidow A, Denkinger CM, Persing D, Kwiatkowski R, Jones M, Alland D (2017) The New Xpert MTB\/RIF Ultra: Improving Detection of Mycobacterium tuberculosis and Resistance to Rifampin in an Assay Suitable for Point-of-Care Testing. mBio 8:e00812\u2013e00817. https:\/\/doi.org\/10.1128\/mBio.00812-17","journal-title":"mBio"},{"key":"5652_CR4","doi-asserted-by":"publisher","first-page":"681","DOI":"10.1007\/s10096-024-05032-1","volume":"44","author":"MQ Wang","year":"2025","unstructured":"Wang MQ, Zheng YF, Hu YQ, Huang JX, Yuan ZX, Wu ZY, Huang LF, Tang CT, Zhang FY, Chen Y, He JK, Guo XG, Yan BM (2025) Diagnostic accuracy of Xpert MTB\/RIF Ultra for detecting pulmonary tuberculosis and rifampicin resistance: a systematic review and meta-analysis. Eur J Clin Microbiol Infect Dis 44:681\u2013702. https:\/\/doi.org\/10.1007\/s10096-024-05032-1","journal-title":"Eur J Clin Microbiol Infect Dis"},{"key":"5652_CR5","doi-asserted-by":"publisher","first-page":"1827","DOI":"10.1007\/s10096-015-2419-5","volume":"34","author":"JH Chen","year":"2015","unstructured":"Chen JH, She KK, Kwong TC, Wong OY, Siu GK, Leung CC, Chang KC, Tam CM, Ho PL, Cheng VC, Yuen KY, Yam WC (2015) Performance of the new automated Abbott RealTime MTB assay for rapid detection of Mycobacterium tuberculosis complex in respiratory specimens. Eur J Clin Microbiol Infect Dis 34:1827\u20131832. https:\/\/doi.org\/10.1007\/s10096-015-2419-5","journal-title":"Eur J Clin Microbiol Infect Dis"},{"key":"5652_CR6","doi-asserted-by":"publisher","first-page":"3022","DOI":"10.1128\/JCM.01144-16","volume":"54","author":"S Hofmann-Thiel","year":"2016","unstructured":"Hofmann-Thiel S, Molodtsov N, Antonenka U, Hoffmann H (2016) Evaluation of the Abbott RealTime MTB and RealTime MTB INH\/RIF Assays for Direct Detection of Mycobacterium tuberculosis Complex and Resistance Markers in Respiratory and Extrapulmonary Specimens. J Clin Microbiol 54:3022\u20133027. https:\/\/doi.org\/10.1128\/JCM.01144-16","journal-title":"J Clin Microbiol"},{"key":"5652_CR7","doi-asserted-by":"publisher","first-page":"212","DOI":"10.1016\/j.diagmicrobio.2015.11.001","volume":"84","author":"V Vinuesa","year":"2016","unstructured":"Vinuesa V, Navarro D, Poujois S, Zaragoza S, Borr\u00e1s R (2016) Performance characteristics of the new Abbott Real Time MTB assay for detection of Mycobacterium tuberculosis complex in respiratory specimens. Diagn Microbiol Infect Dis 84:212\u2013214. https:\/\/doi.org\/10.1016\/j.diagmicrobio.2015.11.001","journal-title":"Diagn Microbiol Infect Dis"},{"key":"5652_CR8","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1016\/j.tube.2017.03.002","volume":"104","author":"V Hini\u0107","year":"2017","unstructured":"Hini\u0107 V, Feuz K, Turan S, Berini A, Frei R, Pfeifer K, Goldenberger D (2017) Clinical evaluation of the Abbott RealTime MTB Assay for direct detection of Mycobacterium tuberculosis-complex from respiratory and non-respiratory samples. Tuberculosis (Edinb) 104:65\u201369. https:\/\/doi.org\/10.1016\/j.tube.2017.03.002","journal-title":"Tuberculosis (Edinb)"},{"key":"5652_CR9","doi-asserted-by":"publisher","first-page":"e00116","DOI":"10.1128\/JCM.00116-18","volume":"56","author":"V Vinuesa","year":"2018","unstructured":"Vinuesa V, Borr\u00e1s R, Briones ML, Clari M\u00c1, Cresencio V, Gim\u00e9nez E, Mu\u00f1oz C, Oltra R, Servera E, Scheelje T, Tornero C, Navarro D (2018) Performance of a Highly Sensitive Mycobacterium tuberculosis Complex Real-Time PCR Assay for Diagnosis of Pulmonary Tuberculosis in a Low-Prevalence Setting: a Prospective Intervention Study. J Clin Microbiol 56:e00116\u2013e00118. https:\/\/doi.org\/10.1128\/JCM.00116-18","journal-title":"J Clin Microbiol"},{"key":"5652_CR10","doi-asserted-by":"publisher","first-page":"e00560","DOI":"10.1128\/JCM.00560-18","volume":"56","author":"RH Berhanu","year":"2018","unstructured":"Berhanu RH, David A, da Silva P, Shearer K, Sanne I, Stevens W, Scott L (2018) Performance of Xpert MTB\/RIF, Xpert Ultra, and Abbott RealTime MTB for Diagnosis of Pulmonary Tuberculosis in a High-HIV-Burden Setting. J Clin Microbiol 56:e00560\u2013e00518. https:\/\/doi.org\/10.1128\/JCM.00560-18","journal-title":"J Clin Microbiol"},{"key":"5652_CR11","doi-asserted-by":"publisher","first-page":"1225","DOI":"10.1016\/j.jmoldx.2020.06.018","volume":"22","author":"L Scott","year":"2020","unstructured":"Scott L, David A, Govender L, Furrer J, Rakgokong M, Waja Z, Martinson N, Eisenberg G, Marlowe E, Stevens W (2020) Performance of the Roche cobas MTB Assay for the Molecular Diagnosis of Pulmonary Tuberculosis in a High HIV Burden Setting. J Mol Diagn 22:1225\u20131237. https:\/\/doi.org\/10.1016\/j.jmoldx.2020.06.018","journal-title":"J Mol Diagn"},{"key":"5652_CR12","doi-asserted-by":"publisher","first-page":"e02168","DOI":"10.1128\/JCM.02168-20","volume":"59","author":"M de Vos","year":"2021","unstructured":"de Vos M, Scott L, David A, Trollip A, Hoffmann H, Georghiou S, Carmona S, Ruhwald M, Stevens W, Denkinger CM, Schumacher SG (2021) Comparative Analytical Evaluation of Four Centralized Platforms for the Detection of Mycobacterium tuberculosis Complex and Resistance to Rifampicin and Isoniazid. J Clin Microbiol 59:e02168\u2013e02120. https:\/\/doi.org\/10.1128\/JCM.02168-20","journal-title":"J Clin Microbiol"},{"key":"5652_CR13","doi-asserted-by":"publisher","first-page":"78","DOI":"10.1016\/j.ijid.2016.02.024","volume":"45","author":"SF Wang","year":"2016","unstructured":"Wang SF, Ou XC, Li Q, Zheng HW, Wang YF, Zhao YL (2016) The Abbott RealTime MTB assay and the Cepheid GeneXpert assay show comparable performance for the detection of Mycobacterium tuberculosis in sputum specimens. Int J Infect Dis 45:78\u201380. https:\/\/doi.org\/10.1016\/j.ijid.2016.02.024","journal-title":"Int J Infect Dis"},{"key":"5652_CR14","doi-asserted-by":"publisher","unstructured":"Horne DJ, Zifodya JS, Shapiro AE, Church EChandler, Kreniske JS, Kay AW, Scandrett K, Steingart KR, Takwoingi Y (2025) Xpert MTB\/RIF Ultra assay for pulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Revs (7):009593. https:\/\/doi.org\/10.1002\/14651858.CD009593.pub3","DOI":"10.1002\/14651858.CD009593.pub3"},{"key":"5652_CR15","doi-asserted-by":"publisher","first-page":"e7660","DOI":"10.7554\/eLife.76605","volume":"11","author":"I Cancino-Mu\u00f1oz","year":"2022","unstructured":"Cancino-Mu\u00f1oz I, L\u00f3pez MG, Torres-Puente M, Villamayor LM, Borr\u00e1s R, Borr\u00e1s-M\u00e1\u00f1ez M, Bosque M, Camarena JJ, Colijn C, Colomer-Roig E, Colomina J, Escribano I, Esparcia-Rodr\u00edguez O, Garc\u00eda-Garc\u00eda F, Gil-Brusola A, Gimeno C, Gimeno-Gasc\u00f3n A, Gomila-Sard B, G\u00f3nzales-Granda D, Gonzalo-Jim\u00e9nez N, Guna-Serrano MR, L\u00f3pez-Hontangas JL, Mart\u00edn-Gonz\u00e1lez C, Moreno-Mu\u00f1oz R, Navarro D, Navarro M, Orta N, P\u00e9rez E, Prat J, Rodr\u00edguez JC, Ruiz-Garc\u00eda MM, Vanaclocha H (2022) Population-based sequencing of Mycobacterium tuberculosis reveals how current population dynamics are shaped by past epidemics. eLife 11:e7660. https:\/\/doi.org\/10.7554\/eLife.76605","journal-title":"eLife"},{"key":"5652_CR16","doi-asserted-by":"publisher","first-page":"7114","DOI":"10.1038\/s41467-024-51266-0","volume":"15","author":"C Mariner-Llicer","year":"2024","unstructured":"Mariner-Llicer C, Goig GA, Torres-Puente M, Vashakidze S, Villamayor LM, Saavedra-Cervera B, Mambuque E, Khurtsilava I, Avaliani Z, Rosenthal A, Gabrielian A, Shurgaia M, Shubladze N, Garc\u00eda-Basteiro AL, L\u00f3pez MG, Comas I (2024) Genetic diversity within diagnostic sputum samples is mirrored in the culture of Mycobacterium tuberculosis across different settings. Nat Commun 15:7114. https:\/\/doi.org\/10.1038\/s41467-024-51266-0","journal-title":"Nat Commun"},{"key":"5652_CR17","doi-asserted-by":"publisher","first-page":"905","DOI":"10.1093\/cid\/ciaa241","volume":"71","author":"CL Daley","year":"2020","unstructured":"Daley CL, Iaccarino JM, Lange C, Cambau E, Wallace RJ, Andrejak C, B\u00f6ttger EC, Brozek J, Griffith DE, Guglielmetti L, Huitt GA, Knight SL, Leitman P, Marras TK, Olivier KN, Santin M, Stout JE, Tortoli E, van Ingen J, Wagner D, Winthrop KL (2020) Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS\/ERS\/ESCMID\/IDSA Clinical Practice Guideline. Clin Infect Dis 71:905\u2013913. https:\/\/doi.org\/10.1093\/cid\/ciaa241","journal-title":"Clin Infect Dis"},{"key":"5652_CR18","doi-asserted-by":"publisher","first-page":"e02170","DOI":"10.1128\/JCM.02170-20","volume":"59","author":"HC Liu","year":"2021","unstructured":"Liu HC, Gao YL, Li DF, Zhao XY, Pan YQ, Zhu CT (2021) Value of Xpert MTB\/RIF using bronchoalveolar lavage fluid for the diagnosis of pulmonary tuberculosis: a systematic review and meta-analysis. J Clin Microbiol 59:e02170\u2013e02120. https:\/\/doi.org\/10.1128\/JCM.02170-20","journal-title":"J Clin Microbiol"}],"container-title":["European Journal of Clinical Microbiology &amp; Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10096-026-05652-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10096-026-05652-9","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10096-026-05652-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T12:32:05Z","timestamp":1788957125000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10096-026-05652-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,9]]},"references-count":18,"alternative-id":["5652"],"URL":"https:\/\/doi.org\/10.1007\/s10096-026-05652-9","relation":{},"ISSN":["0934-9723","1435-4373"],"issn-type":[{"value":"0934-9723","type":"print"},{"value":"1435-4373","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,9]]},"assertion":[{"value":"12 February 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 August 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 September 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The current study was approved by the Institutional Review Board (IRB) Research Ethics Committee of Hospital Cl\u00ednico Universitario INCLIVA (2022\/277). A waiver of informed consent documentation was issued by the IRB.","order":1,"name":"Ethics","label":"Ethical approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"David Navarro has received honoraria for conferences from Abbott Diagnostics.","order":2,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}]}}