{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T18:01:08Z","timestamp":1791914468778,"version":"4.3.4"},"reference-count":20,"publisher":"American Society for Microbiology","issue":"5","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\/"},{"start":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:00:00Z","timestamp":1747180800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2025,5,14]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      The aim of this study was to evaluate the performance of the automated cobas MTB-Real-Time PCR assay for the rapid direct detection of\n                      <jats:italic toggle=\"yes\">Mycobacterium tuberculosis<\/jats:italic>\n                      complex (MTBC) in clinical specimens and the ability of the cobas MTB-RIF\/INH assay to correctly detect drug resistance to rifampin (RIF) and isoniazid (INH). The PCR assays were set up on the automated Cobas 6800 system, and the results were compared to liquid culture using BACTEC mycobacteria growth indicator tubes 960 TB system as the gold standard and line probe assays or sequencing results. A total of 500 N-acetyl-L-cysteine\/sodium hydroxide (NALC-NaOH)-processed sputum samples were tested with the respective methods. The performance of MTBC detection in pulmonary specimens showed 91.8% sensitivity and 99.3% specificity in comparison to culture. The sensitivity for acid-fast bacteria (AFB) smear-positive specimens and for AFB smear-negative specimens was 100% and 85.1%, respectively. Due to the low prevalence of tuberculosis (TB) resistance in Germany, a collection of resistant TB strains with a wide variety of mutations was analyzed. The cobas MTB-RIF\/INH assay detected 19 out of 21 INH-resistant and 22 out of 24 RIF-resistant TB strains. In conclusion, the cobas MTB and the cobas MTB-RIF\/INH assays implemented on the automated cobas6800 instrument are reliable and versatile tools for the detection of MTB and RIF\/INH resistance.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>Our manuscript addresses the WHO recommendation for the use of \u201cmoderate-complexity automated NAATs for detection of TB and resistance to rifampicin and isoniazid\u201d as a part of the WHO End TB Strategy. Rapid detection of tuberculosis (TB) patients is essential to preventing TB transmission and finally reducing TB burden. In this study, we present data on the sensitivity and specificity of the novel cobas MTB assay for TB detection in a low-incidence country, demonstrating highly promising results. Additionally, by analyzing TB strains with various mutations conferring resistance to INH and\/or RMP, we assess the opportunities and limitations of the cobas MTB-RIF\/INH assay in reliably detecting drug resistance in sputum specimens, thereby facilitating the early onset of appropriate treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.01959-24","type":"journal-article","created":{"date-parts":[[2025,3,25]],"date-time":"2025-03-25T09:00:29Z","timestamp":1742893229000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":6,"title":["Evaluation of the cobas MTB and MTB-RIF\/INH assay in clinical samples for the detection of\n                    <i>Mycobacterium tuberculosis<\/i>\n                    in respiratory specimens"],"prefix":"10.1128","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0631-5105","authenticated-orcid":true,"given":"Ulrich","family":"Eigner","sequence":"first","affiliation":[{"name":"Labor Limbach","place":["Heidelberg, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmin","family":"K\u00f6ffer","sequence":"additional","affiliation":[{"name":"Labor Limbach","place":["Heidelberg, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrike","family":"Betz","sequence":"additional","affiliation":[{"name":"Labor Limbach","place":["Heidelberg, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janina","family":"Koglin","sequence":"additional","affiliation":[{"name":"Labor Limbach","place":["Heidelberg, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elvira","family":"Richter","sequence":"additional","affiliation":[{"name":"Labor Limbach","place":["Heidelberg, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","volume-title":"Global tuberculosis report 2023","author":"World Health Organization","year":"2023","unstructured":"World Health Organization. 2023. Global tuberculosis report 2023. World Health Organization, Geneva."},{"key":"e_1_3_3_3_2","unstructured":"Brodhun B Altmann D Hauer B Kr\u00f6ger S Haas W. 2023. Bericht zur Epidemiologie der Tuberkulose in Deutschland f\u00fcr 2022. Berlin Robert Koch-Institut"},{"key":"e_1_3_3_4_2","volume-title":"WHO consolidated guidelines on tuberculosis. Module 3: diagnosis - rapid diagnostics for tuberculosis detection","author":"WHO","year":"2021","unstructured":"WHO. 2021. WHO consolidated guidelines on tuberculosis. Module 3: diagnosis - rapid diagnostics for tuberculosis detection"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmoldx.2022.10.001"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00531-18"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmoldx.2020.06.013"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1080\/14737159.2021.1997594"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz932"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-020-03847-2"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.00132-21"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0249734"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00747-2020"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD013694.pub2"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-018-03463-1"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1111\/apm.13040"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmoldx.2020.06.018"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02983-20"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02168-20"},{"key":"e_1_3_3_20_2","volume-title":"Catalogue of mutations in Mycobacterium tuberculosis complex and their association with drug resistance","author":"World Health Organization","year":"2023","unstructured":"World Health Organization. 2023. Catalogue of mutations in Mycobacterium tuberculosis complex and their association with drug resistance. 2nd ed. World Health Organization, Geneva.","edition":"2"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2020.25.9.2000152"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01959-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01959-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T09:01:29Z","timestamp":1747213289000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.01959-24"}},"subtitle":[],"editor":[{"given":"Melissa B.","family":"Miller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,5,14]]},"references-count":20,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5,14]]}},"alternative-id":["10.1128\/jcm.01959-24"],"URL":"https:\/\/doi.org\/10.1128\/jcm.01959-24","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,14]]},"assertion":[{"value":"2024-12-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-06","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e01959-24"}}