{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T02:07:01Z","timestamp":1791684421119,"version":"4.3.4"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T00:00:00Z","timestamp":1774483200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100016545","name":"Roche Diagnostics GmbH","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016545","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>High-sensitivity cardiac troponin (hs-cTn) assays are recommended for the diagnosis of acute myocardial infarction. Here, we characterize the analytical performance of a next-generation hs-cTn assay, Elecsys\u00ae Troponin T hs Gen 6 (Roche Diagnostics International).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Surplus lithium-heparin plasma or serum samples from patients or healthy volunteers were run on Cobas\u00ae e 801, e 402, and Pro analyzers. Limits of blank (LoB), limits of detection (LoD), and limits of quantitation (LoQ) were determined according to CLSI EP17-A2, with target values of 1.0 and 1.5 ng\/L for LoB\/LoD and 3.0 ng\/L (10% CV) and 1.5 ng\/L (20% CV) for LoQ, respectively. Precision was measured, per CLSI EP17-A2, using 3 QC samples (approximately 4, 30, and 220 ng\/L), 12 native samples, and 3 reagent lots. Linearity, per CLSI EP06-Ed2, was determined by diluting samples with cardiac troponin T (cTnT) concentration above the measuring range with a low\/blank sample. Interference (per Glick) with endogenous and assay components at 5 cTnT concentrations was assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Measured values for LoB, LoD, and LoQ at 10% and 20% CV were 0.1 to 0.7 ng\/L, 0.3 to 1.4 ng\/L, 1.0 to 2.9 ng\/L, and 0.4 to 1.2 ng\/L, respectively. Repeatability CVs were 1.0 to 5.8% for mean cTnT concentrations of 2.6 to 9230 ng\/L in lithium-heparin plasma. High precision was shown across lots, and linearity was observed across the measuring range (1.5 to 9500 ng\/L, all Pearson's r = 1.00). No interferences were observed, specified up to \u22641000 mg\/dL hemoglobin, \u226450 mg\/dL [\u2264855 \u00b5mol\/L] icterus\/bilirubin, and \u22641200 ng\/mL biotin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The analytical performance characterization of the assay demonstrated high sensitivity, high precision at the low end and across the measuring range, and resistance to interference.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jalm\/jfag031","type":"journal-article","created":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T10:49:51Z","timestamp":1774522191000},"page":"1009-1025","source":"Crossref","is-referenced-by-count":8,"title":["Analytical Performance Evaluation of the Cardiac Troponin T High Sensitivity Gen 6 Assay"],"prefix":"10.1093","volume":"11","author":[{"given":"Marko","family":"Knoll","sequence":"first","affiliation":[{"name":"Research and Development, Roche Diagnostics GmbH , Penzberg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4841-9922","authenticated-orcid":false,"given":"Lori B","family":"Daniels","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Department of Medicine, University of California San Diego , La Jolla, CA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1120-6405","authenticated-orcid":false,"given":"Christian","family":"Mueller","sequence":"additional","affiliation":[{"name":"Cardiovascular Research Institute Basel and Department of Cardiology, University Hospital Basel, University of Basel , Basel ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0533-7991","authenticated-orcid":false,"given":"Nicholas L","family":"Mills","sequence":"additional","affiliation":[{"name":"British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh , Edinburgh ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1025-2872","authenticated-orcid":false,"given":"Evangelos","family":"Giannitsis","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine III, Cardiology University Hospital of Heidelberg , Heidelberg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alisa F A","family":"R\u00f6sser","sequence":"additional","affiliation":[{"name":"Research and Development, Roche Diagnostics GmbH , Penzberg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dunja","family":"Kurtoic","sequence":"additional","affiliation":[{"name":"Clinical Biostatistics, Roche Diagnostics International GmbH , Penzberg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annika","family":"Wahl","sequence":"additional","affiliation":[{"name":"Clinical Biostatistics, Roche Diagnostics International GmbH , Penzberg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9089-8130","authenticated-orcid":false,"given":"Richard","family":"Body","sequence":"additional","affiliation":[{"name":"Emergency Department, Manchester University NHS Foundation Trust, Manchester Academic Health Science Center , Manchester ,","place":["United Kingdom"]},{"name":"Division of Cardiovascular Sciences, University of Manchester , Manchester ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert H","family":"Christenson","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Maryland School of Medicine , Baltimore, MD ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christa","family":"Cobbaert","sequence":"additional","affiliation":[{"name":"Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center , Leiden ,","place":["the Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher R","family":"deFilippi","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of Maryland School of Medicine , Baltimore, MD ,","place":["United States"]},{"name":"Department of Medicine, University of Maryland School of Medicine , Baltimore, MD ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8806-5778","authenticated-orcid":false,"given":"Kai M","family":"Eggers","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, Uppsala University , Uppsala ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Inoue","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Tokyo Heart Rhythm Clinic Shinjuku , Tokyo ,","place":["Japan"]},{"name":"Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine , Tokyo ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1183-3959","authenticated-orcid":false,"given":"Allan S","family":"Jaffe","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Mayo Clinic , Rochester, MN ,","place":["United States"]},{"name":"Department of Laboratory Medicine and Pathology, Mayo Clinic , Rochester, MN ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cian P","family":"McCarthy","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Heart and Vascular Institute, Massachusetts General Brigham, and Harvard Medical School , Boston, MA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"McCord","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Heart and Vascular Institute, Henry Ford Health , Detroit, MI ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9478-2757","authenticated-orcid":false,"given":"Johannes T","family":"Neumann","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Heart and Vascular Center Hamburg , Hamburg ,","place":["Germany"]},{"name":"Center for Population Health Innovation, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf , Hamburg ,","place":["Germany"]},{"name":"German Center for Cardiovascular Research, Partner Site Hamburg\/Kiel\/L\u00fcbeck , Hamburg ,","place":["Germany"]},{"name":"Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University , Melbourne ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Torbj\u00f8rn","family":"Omland","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Akershus University Hospital , L\u00f8renskog ,","place":["Norway"]},{"name":"K. G. Jebsen Center for Cardiac Biomarkers, Institute of Clinical Medicine, University of Oslo , Oslo ,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"Papendick","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, The Royal Adelaide Hospital, Central Adelaide Local Health Network , Adelaide, South Australia ,","place":["Australia"]},{"name":"Adelaide Medical School, University of Adelaide , Adelaide, South Australia ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4800-2972","authenticated-orcid":false,"given":"Yader","family":"Sandoval","sequence":"additional","affiliation":[{"name":"Minneapolis Heart Institute, Abbott Northwestern Hospital and Center for Coronary Artery Disease, Minneapolis Heart Institute Foundation , Minneapolis, MN ,","place":["United 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Medical Center, University of Kansas Health System , Kansas City, KS ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3814-6542","authenticated-orcid":false,"given":"Raphael","family":"Twerenbold","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Heart and Vascular Center Hamburg , Hamburg ,","place":["Germany"]},{"name":"Center for Population Health Innovation, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf , Hamburg ,","place":["Germany"]},{"name":"German Center for Cardiovascular Research, Partner Site Hamburg\/Kiel\/L\u00fcbeck , Hamburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W Frank","family":"Peacock","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, Baylor College of Medicine , Houston, TX ,","place":["United 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