Analytical Performance Evaluation of the Cardiac Troponin T High Sensitivity Gen 6 Assay
Year: 2026
Type: article
Abstract: BACKGROUND: 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® Troponin T hs Gen 6 (Roche Diagnostics International). METHODS: Surplus lithium-heparin plasma or serum samples from patients or healthy volunteers were run on Cobas® 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. RESULTS: 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 ≤1000 mg/dL hemoglobin, ≤50 mg/dL [≤855 µmol/L] icterus/bilirubin, and ≤1200 ng/mL biotin. CONCLUSIONS: 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.
DOI: 10.1093/jalm/jfag031
Authors: Marko Knoll, Lori B Daniels, Christian Mueller, Nicholas L Mills, Evangelos Giannitsis, Alisa F A Rösser, Dunja Kurtoic, Annika Wahl, Richard Body, Robert H Christenson, Christa Cobbaert, Christopher R deFilippi, Kai M Eggers, Kenji Inoue, Allan S Jaffe, Cian P McCarthy, James McCord, Johannes T Neumann, Torbjørn Omland, Cynthia Papendick, Yader Sandoval, Jack Wei Chieh Tan, Martin P Than, Raphael Twerenbold, W Frank Peacock, Steven J R Meex
Institutions: University of California San Diego, University of Basel, University Hospital of Basel, British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Heidelberg University, University Hospital Heidelberg, Roche Diagnostics International AG (Switzerland), Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, University of Maryland, Baltimore, Leiden University Medical Center, Uppsala University, Juntendo University, Mayo Clinic, Harvard University, Massachusetts General Hospital, Mass General Brigham, Henry Ford Health, Henry Ford Hospital, Universität Hamburg, University Medical Center Hamburg-Eppendorf, German Centre for Cardiovascular Research, Monash University, University of Oslo, Akershus University Hospital, Royal Adelaide Hospital, Central Adelaide Local Health Network, The University of Adelaide, Abbott Northwestern Hospital, Minneapolis Heart Institute Foundation, Duke-NUS Medical School, National Heart Centre Singapore, Sengkang General Hospital, Christchurch Hospital, University of Kansas Medical Center, University of Otago, Baylor College of Medicine, Maastricht University Medical Centre, Maastricht University
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,212
OpenAlex ID: W7140623175