Establishing Reference Values in Healthy Participants for the Cardiac Troponin T High-Sensitivity Gen 6 Assay: REF-TSIX Global Reference Study
Recommended Citation
Daniels LB, Mueller C, Giannitsis E, Meex SJR, Buehlmann D, Dilba P, Bendig G, Cole M, Body R, Christenson RH, Cobbaert C, deFilippi CR, Eggers KM, Inoue K, Jaffe AS, McCarthy CP, McCord J, Neumann JT, Omland T, Papendick C, Sandoval Y, Tan JWC, Than MP, Twerenbold R, Peacock WF, and Mills NL. Establishing Reference Values in Healthy Participants for the Cardiac Troponin T High-Sensitivity Gen 6 Assay: REF-TSIX Global Reference Study. Clin Chem 2026.
Document Type
Article
Publication Date
1-21-2026
Publication Title
Clinical chemistry
Keywords
99th percentile URL; assay; cardiac troponin; high sensitivity; reference range; sex-specific; uniform; upper reference limit
Abstract
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 (Li-Hep) 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 International Federation of Clinical Chemistry guidance. Uniform and sex-specific 99th percentile URLs and non-parametric 95% confidence intervals (CI) were determined in plasma and serum separately and combined.
RESULTS: The final study population comprised 4147 participants (52.5% female) with a median (25-75th 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.
PubMed ID
41564003
ePublication
ePub ahead of print
