Establishing reference values in healthy participants for the cardiac troponin T high-sensitivity gen 6 assay: REF-TSIX global reference study

Author(s):
Daniels, L.B.; Mueller, C.; Giannitsis, E.; Meex, S.J.R.; Buehlmann, D.; Dilba, P.; Bendig, G.; Cole, M.; Body, R.; Christenson, R.H.; Cobbaert, C.; Defilippi, C.R.; Eggers, K.M.; Inoue, K.; Jaffe, A.S.; Mccarthy, C.P.; Mccord, J.; Neumann, J.T.; Omland, T.; Papendick, C.; Sandoval, Y.; Tan, J.W.C.; Than, M.P.; Twerenbold, R.; Peacock, W.F.; Mills, N.L.; Jacobs, M.B.; Lucksinger, G.; Powell, R.; Johnson, D.; Coleman, H.; Fein, M.; Surber, J.; Vu, J.; Hassman, M.; Hernandez, J.; Kirstein, J.; Tomaszewski, C.; Runyon, M.; Gong, J.A.T.; Wein, D.; Andrabi, S.; Kopin, D.; Larrain, G.; Tahirkheli, N.; Clemency, B.; Abdullah, S.; Hira, R.; Klausner, H.; Mahler, S.; Crystal, C.; Headden, G.; Chaille, P.; Cannon, C.; Limkakeng, A.; Tolia, V.; Knapp, B.; Massoomi, M.; Ko, E.M.Y.; Luzzi, V.; Christenson, R.; Tran, N.; Carson, J.P.; Niederdöckl, J.; Cacioppo, F.; Kolev, E.; Popov, T.; Petrov, A.; Hazarbasanov, D.; Simova, L.; Magimaiseelan, L.S.; Kosch, C.; Klein, G.; Mehltretter, K.; Sauter, J.; Baumann, S.; Moeckel, M.; Müller-Hennessen, M.; Biener, M.; Findeisen, P.; Scharnhorst, V.; Wilczek-Kosowska, U.; Zimmer-Satora, E.; Krecipro-Nizinska, E.; Mirö, O.; Diaz, V.J.; Christ, M.; Lynch, S.; Matsuki, S.; Eto, T.; Tanaka, T.; Hanada, R.; Nakagami, T.; Nakama, T.; Kadota, K.; Jing, S.; Yu, S.W.; Zhang, H.X.; Zhang, J.; Huo, Y.; Zhang, Y.; Yan, L.; Jiang, L.Y.; Chen, W.Q.; Huang, J.Y.; Zhao, Y.; Guan, L.; Yang, Y.H.; Zhang, Q.; Qiu, Z.H.
Published
2026
Publication type
Article / Letter to editor

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 (R) 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 (R) 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.

Date issued
2026-01-21
Language
English
Publisher
OXFORD UNIV PRESS INC
Is part of
Clinical Chemistry
hdl
1887/4299086
doi
10.1093/clinchem/hvag011