Citations 2
Establishing Reference Values in Healthy Participants for the Cardiac Troponin T High-Sensitivity Gen 6 Assay: REF-TSIX Global Reference Study
Daniels, Lori B. , Mueller, Christian, Giannitsis, Evangelos, Meex, Steven J. R., Buehlmann, David, Dilba, Peter, Bendig, Garnet, Cole, Mette, Body, Richard, Christenson, Robert H, deFilippi, Christopher R, Inoue, Kenji, Jaffe, A S, McCarthy, Cian P. , McCord, J., Neumann, Johannes T, Omland, T., Papendick, Cynthia , Sandoval, Yader, Twerenbold, Raphael, Peacock, W Frank, Mills, Nicholas L, investigators, the TSIX, Jacobs, Michael B., Lucksinger, Gregg, Powell, Richard, Johnson, Daniel, Coleman, Hugh, Fein, M, Surber, Joseph, Vu, Jack B., Hassman, Michael, Hernandez, John, Kirstein, Judith, Tomaszewski, Christian, Runyon, Michael S. , Gong, Jonathan , Wein, D., Andrabi, Sara , Kopin, David , Larrain, Germain, Tahirkheli, Naheem, Clemency, Brian, Abdullah, Shuaib, Hira, Ravi S. , Klausner, H A, Mahler, Simon A. , Crystal, Chad, Headden, Gary, Chaille, Peter, Cannon, Chad Aaron, Limkakeng, Alexander, Tolia, Vaishal , Knapp, Barry J., Massoomi, Mohammad, Sandoval, Yader, Ko, Emily, Luzzi, Verónica, Christenson, Robert, Carson, Jennifer Powers , Cacioppo, F , Kolev, E., Petrov, Andrey, Hazarbasanov, Dobri , Simova, lana, Magimaiseelan, Luci Suganthi, Kosch, Christine, Klein, G, Mehltretter, Kai, Sauter, Joachim, Baumann, Sybille, Moeckel, Martin, Twerenbold, Raphael, Muller-Hennessen, Matthias, Biener, Moritz , Findeisen, P., Omland, Torbjøm, Wilczek-Kosowska, Urszula, Zimmer-Satora, Ewa, Krecipro-Nizińska, Ewa, Miró, O, Díaz, Víctor Jiménez , Mueller, C, Christ, Michael, Lynch, Stephen, BODY, R. A. F., Matsuki, Shunji, Eto, Takashi, Tanaka, Takanori, Hanada, Ryuzo, Nakagami, Takuo, Nakama, T, Kadota, K., Jing, Shan, Yu, Shuwen, Zhang, Hongxuan, Zhang, Jun, Huo, Yong, Zhang, Yan, Yan, Li, Jiang, Longyuan, Chen, Weiqiang, Huang, Jianying, Zhao, Yan, Guan, Ling, Yang, Yanhua, Zhang, Qin, Qiu, Zhaohui, Body, Richard , Neumann, Franz–Josef , Müller, Christian , Mueller, Christian , Body, Rick , Eggers, Kai M. , Jaffe, Allan S. , Neumann, Johannes T , Sandoval, Yader , Tan, Jack Wei Chieh , Than, Martin , Twerenbold, Raphael , Mills, Nicholas L , Daniels, Lori B , Giannitsis, Evangelos , Meex, Steven J.R. , Christenson, Robert H. , Cobbaert, Christa M. , deFilippi, Christopher R. , McCord, James , Omland, Torbjørn , Sandoval, Yader , Tan, Jack Wei Chieh , Than, Martin , Twerenbold, Raphael , Surber, Joseph, Tomaszewski, Christian, Clemency, Brian, Headden, Gary , Cannon, Chad, Knapp, Barry , Tran, Nam K , Niederdöckl, Jan Daniel , Kolev, Emil, Popov, Todor, Sauter, Joachim, Baumann, Sybille , Möeckel, Martin , Müller‐Hennessen, Matthias, Findeisen, Peter, Scharnhorst, Volkher , Omland, T, Krecipro-Nizińska, Ewa, Christ, Michael , Nakagami, Takuo, Huo, Yong
Clinical Chemistry | January 18, 2026 | Volume: 72 | Issue: 4 | Pages: 488-502
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 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.
Educational Recommendations on Selected Analytical and Clinical Aspects of Natriuretic Peptides with a Focus on Heart Failure: A Report from the IFCC Committee on Clinical Applications of Cardiac Bio-Markers
Kavsak, Peter A. , Saenger, Amy K., Jaffe, Allan S. , Pulkki, Kari , Omland, Tobjørn, Body, Richard , Ordóñez‐Llanos, Jordi , Apple, Fred S. , Body, Rick , Lam, Carolyn S.P. , Jaffe, Allan S. , Collinson, Paul , Omland, T, Lefèvre, Guillaume
Clinical Chemistry | August 6, 2019 | Volume: 65 | Issue: 10 | Pages: 1221-1227
Abstract The IFCC Committee on Clinical Applications of Cardiac Bio-Markers (C-CB) has directives and initiatives focused on providing evidence-based educational resources to aid and improve understanding around key analytical and clinical aspects of cardiac biomarkers used in clinical practice and the research setting. As a task force, we have previously published position statements and recommendations focused on use and analytical aspects of high-sensitivity cardiac troponin assays. The current educational document is the first from the C-CB highlighting important biochemical, analytical, and clinical aspects as they relate to the natriuretic peptides (NPs), including B-type natriuretic peptide (BNP) and N-terminal pro–B-type natriuretic peptide (NT-proBNP), with a focus on heart failure.