TY - JOUR
T1 - Establishing Reference Values in Healthy Participants for the Cardiac Troponin T High-Sensitivity Gen 6 Assay
T2 - REF-TSIX Global Reference Study
AU - the TSIX investigators
AU - Daniels, Lori B.
AU - Mueller, Christian
AU - Giannitsis, Evangelos
AU - Meex, Steven J.R.
AU - Buehlmann, David
AU - Dilba, Peter
AU - Bendig, Garnet
AU - Cole, Mette
AU - Body, Richard
AU - Christenson, Robert H.
AU - Cobbaert, Christa
AU - deFilippi, Christopher R.
AU - Eggers, Kai M.
AU - Inoue, Kenji
AU - Jaffe, Allan S.
AU - McCarthy, Cian P.
AU - McCord, James
AU - Neumann, Johannes T.
AU - Omland, Torbjørn
AU - Papendick, Cynthia
AU - Sandoval, Yader
AU - Tan, Jack Wei Chieh
AU - Than, Martin P.
AU - Twerenbold, Raphael
AU - Peacock, W. Frank
AU - Mills, Nicholas L.
AU - Jacobs, Michael B.
AU - Lucksinger, Gregg
AU - Powell, Richard
AU - Johnson, Daniel
AU - Coleman, Hugh
AU - Fein, Melanie
AU - Surber, Joseph
AU - Vu, Jack
AU - Hassman, Michael
AU - Hernandez, John
AU - Kirstein, Judith
AU - Tomaszewski, Christian
AU - Runyon, Michael
AU - Gong, Jonathan
AU - Wein, David
AU - Andrabi, Sara
AU - Kopin, David
AU - Larrain, Germain
AU - Tahirkheli, Naheem
AU - Clemency, Brian
AU - Abdullah, Shuaib
AU - Hira, Ravi
AU - Klausner, Howard
AU - Clemency, Brian
N1 - Publisher Copyright:
© The Author(s) 2026. Published by Oxford University Press on behalf of Association for Diagnostics & Laboratory Medicine. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
PY - 2026/4
Y1 - 2026/4
N2 - Background: Measurement of cardiac troponin (cTn) using high-sensitivity assays is recommended for the diagnosis of myocardial infarction. We determined sex-specific and uniform 99th percentile upper reference limits (URLs) using the new Elecsys® Troponin T high-sensitivity Gen 6 assay in a global, healthy reference range cohort. Methods: Lithium-heparin plasma and serum samples were prospectively collected from apparently healthy individuals aged ≥20 years across 34 global sites in the United States, Europe, China, and Japan. cTnT was measured using the Troponin T high-sensitivity Gen 6 assay on the Cobas® e 801 analyzer. Exclusion criteria were defined according to the 2022 IFCC guidance. Uniform and sex-specific 99th percentile URLs and nonparametric 95% CIs were determined in plasma and serum separately and combined. Results: The final study population comprised 4147 participants (52.5% female) with a median (25th–75th percentiles) age of 48.0 (33.0–59.0) years; 45.8%, 47.9%, 5.2%, and 1.1% were White, Asian, Black, and other/unknown, respectively. For sample matrices combined (n = 8294), 81.0% and 99.2% of cTnT values were above the limit of detection in females and males, respectively. Sex-specific 99th percentile URLs (95% CI) were 18 (16–23) ng/L for females and 32 (28–35) ng/L for males; the uniform 99th percentile URL was 27 (24–31) ng/L. URLs were comparable in plasma and serum samples. Conclusions: This study determined sex-specific and uniform 99th percentile URLs for the Troponin T high-sensitivity Gen 6 assay that were comparable irrespective of the matrix used in a large, global, healthy reference population.
AB - Background: Measurement of cardiac troponin (cTn) using high-sensitivity assays is recommended for the diagnosis of myocardial infarction. We determined sex-specific and uniform 99th percentile upper reference limits (URLs) using the new Elecsys® Troponin T high-sensitivity Gen 6 assay in a global, healthy reference range cohort. Methods: Lithium-heparin plasma and serum samples were prospectively collected from apparently healthy individuals aged ≥20 years across 34 global sites in the United States, Europe, China, and Japan. cTnT was measured using the Troponin T high-sensitivity Gen 6 assay on the Cobas® e 801 analyzer. Exclusion criteria were defined according to the 2022 IFCC guidance. Uniform and sex-specific 99th percentile URLs and nonparametric 95% CIs were determined in plasma and serum separately and combined. Results: The final study population comprised 4147 participants (52.5% female) with a median (25th–75th percentiles) age of 48.0 (33.0–59.0) years; 45.8%, 47.9%, 5.2%, and 1.1% were White, Asian, Black, and other/unknown, respectively. For sample matrices combined (n = 8294), 81.0% and 99.2% of cTnT values were above the limit of detection in females and males, respectively. Sex-specific 99th percentile URLs (95% CI) were 18 (16–23) ng/L for females and 32 (28–35) ng/L for males; the uniform 99th percentile URL was 27 (24–31) ng/L. URLs were comparable in plasma and serum samples. Conclusions: This study determined sex-specific and uniform 99th percentile URLs for the Troponin T high-sensitivity Gen 6 assay that were comparable irrespective of the matrix used in a large, global, healthy reference population.
UR - https://www.scopus.com/pages/publications/105034918972
U2 - 10.1093/clinchem/hvag011
DO - 10.1093/clinchem/hvag011
M3 - Article
C2 - 41564003
AN - SCOPUS:105034918972
SN - 0009-9147
VL - 72
SP - 488
EP - 502
JO - Clinical Chemistry
JF - Clinical Chemistry
IS - 4
ER -