{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T18:34:17Z","timestamp":1790274857617,"version":"4.1.0"},"reference-count":19,"publisher":"American Society for Microbiology","issue":"8","license":[{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"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":[[2026,8,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Tuberculosis (TB) remains a major global health challenge, requiring rapid, reliable molecular tests to detect the\n                      <jats:italic toggle=\"yes\">Mycobacterium tuberculosis<\/jats:italic>\n                      complex (MTBC) and resistance to the drugs that cause multidrug resistance, i.e., rifampicin and isoniazid. Although many moderate-complexity automated nucleic acid amplification tests use multiple targets to improve sensitivity, previous versions of FluoroType MTBDR (FTv2old; Bruker-Hain) relied on a single MTBC DNA target, often necessitating the use of an initial multilocus MTBC assay in the workflow to achieve comparable sensitivity. This prospective head-to-head study compared FTv2old with an updated version (FTv2new) that includes the multi-copy IS\n                      <jats:italic toggle=\"yes\">6110<\/jats:italic>\n                      insertion sequence to improve MTBC detection. Using 1,483 clinical specimens from pulmonary and extrapulmonary sources, with culture and whole-genome sequencing (WGS) as reference standards, FTv2new showed a significant 17-percentage-point increase in overall sensitivity, reaching 87% compared with 70% for FTv2old (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.008). The improvement was particularly notable in microscopy-negative, culture-positive samples, where the sensitivity increased from 50% to 78% (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = 0.008). Specificity remained high and comparable between versions at 99%. Because the assay\u2019s resistance-conferring targets remained unchanged, the capability for resistance profiling did not improve significantly. These findings indicate that inclusion of the IS\n                      <jats:italic toggle=\"yes\">6110<\/jats:italic>\n                      target closes the performance gap of the FluoroType platform, eliminating the need for reflex testing and streamlining laboratory workflows for high-throughput tuberculosis screening.\n                    <\/jats:p>\n                    <jats:p\/>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>\n                        Tuberculosis remains a major global health threat, and rapid, accurate diagnosis is essential for disease control. This study evaluates an updated molecular assay for detecting the\n                        <jats:italic toggle=\"yes\">Mycobacterium tuberculosis<\/jats:italic>\n                        complex (MTBC). Earlier versions of this assay relied on a single genetic target and were less sensitive than competing methods. The inclusion of a multi-copy target significantly improves MTBC detection, particularly in specimens with low bacterial loads that are frequently microscopy-negative. This improvement is clinically relevant, enabling faster, more reliable diagnosis while eliminating the need for additional, time-consuming reflex testing, thereby streamlining laboratory workflows and supporting timely initiation of appropriate treatment, thereby supporting global efforts to eliminate TB.\n                      <\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.00268-26","type":"journal-article","created":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T13:02:02Z","timestamp":1782219722000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":1,"title":["Increased sensitivity of the updated FluoroType MTBDR V2 with addition of IS\n                    <i>6110<\/i>\n                    analysis"],"prefix":"10.1128","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0797-1080","authenticated-orcid":true,"given":"Erik","family":"Svensson","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0417ye583","id-type":"ROR","asserted-by":"publisher"}],"name":"International Reference Laboratory of Mycobacteriology, Statens Serum Institut","place":["Copenhagen, Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6430-4586","authenticated-orcid":true,"given":"Dorte Bek","family":"Folkvardsen","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0417ye583","id-type":"ROR","asserted-by":"publisher"}],"name":"International Reference Laboratory of Mycobacteriology, Statens Serum Institut","place":["Copenhagen, Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1282-394X","authenticated-orcid":true,"given":"Anders","family":"Norman","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0417ye583","id-type":"ROR","asserted-by":"publisher"}],"name":"International Reference Laboratory of Mycobacteriology, Statens Serum Institut","place":["Copenhagen, Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4401-7598","authenticated-orcid":true,"given":"Erik Michael","family":"Rasmussen","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0417ye583","id-type":"ROR","asserted-by":"publisher"}],"name":"International Reference Laboratory of Mycobacteriology, Statens Serum Institut","place":["Copenhagen, Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2601-2718","authenticated-orcid":true,"given":"Troels","family":"Lillebaek","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0417ye583","id-type":"ROR","asserted-by":"publisher"}],"name":"International Reference Laboratory of Mycobacteriology, Statens Serum Institut","place":["Copenhagen, Denmark"]},{"id":[{"id":"https:\/\/ror.org\/035b05819","id-type":"ROR","asserted-by":"publisher"}],"name":"Global Health Section, Department of Public Health, University of Copenhagen","place":["Copenhagen, Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_4_2_2","unstructured":"World Health Organization. 2025. Global tuberculosis report 2025. Geneva Switzerland World Health Organization. https:\/\/www.who.int\/teams\/global-programme-on-tuberculosis-and-lung-health\/tb-reports\/global-tuberculosis-report-2025."},{"key":"e_1_3_4_3_2","unstructured":"World Health Organization. 2025. WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis. Geneva Switzerland World Health Organization"},{"key":"e_1_3_4_4_2","unstructured":"World Health Organization. 2025. WHO operational handbook on tuberculosis. Module 3: Diagnosis. Geneva Switzerland World Health Organization. https:\/\/www.who.int\/publications\/i\/item\/9789240110991."},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1128\/mBio.00812-17"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmoldx.2020.06.018"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02168-20"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2021.04.022"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2024.04.006"},{"key":"e_1_3_4_10_2","unstructured":"European Centre for Disease Prevention and Control. 2025. Handbook on tuberculosis laboratory diagnostic methods in the European Union. LU: Publications Office of the European Union 2026 Jan 12. Available from: https:\/\/data.europa.eu\/doi\/10.2900\/2075970"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0279644"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(17)30691-6"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz932"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01144-16"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0251602"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.5588\/ijtld.18.0615"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmoldx.2020.06.013"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02983-20"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-020-03847-2"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD012768.pub3"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00268-26","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00268-26","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T13:01:20Z","timestamp":1786539680000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.00268-26"}},"subtitle":[],"editor":[{"given":"Melissa B.","family":"Miller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,8,12]]},"references-count":19,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2026,8,12]]}},"alternative-id":["10.1128\/jcm.00268-26"],"URL":"https:\/\/doi.org\/10.1128\/jcm.00268-26","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,12]]},"assertion":[{"value":"2026-02-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-31","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-23","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00268-26"}}