Analytical Considerations in Deriving 99th Percentile Upper Reference Limits for High-Sensitivity Cardiac Troponin Assays: Educational Recommendations from the IFCC Committee on Clinical Application of Cardiac Bio-Markers

Aakre, Kristin M, Saenger, Amy K, Body, Rick, Collinson, Paul ORCID: 0000-0002-7000-5996, Hammarsten, Ola, Jaffe, Allan S, Kavsak, Pete, Omland, Torbjorn, Ordonez-Lianos, Jordi and Apple, Fred S (2022) Analytical Considerations in Deriving 99th Percentile Upper Reference Limits for High-Sensitivity Cardiac Troponin Assays: Educational Recommendations from the IFCC Committee on Clinical Application of Cardiac Bio-Markers. CLINICAL CHEMISTRY, 68 (8). pp. 1022-1030.

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Official URL: http://dx.doi.org/10.1093/clinchem/hvac092

Abstract

The International Federation of Clinical Chemistry Committee on Clinical Application of Cardiac Bio-Markers provides evidence-based educational documents to facilitate uniform interpretation and utilization of cardiac biomarkers in clinical laboratories and practice. The committee's goals are to improve the understanding of certain key analytical and clinical aspects of cardiac biomarkers and how these may interplay in clinical practice. Measurement of high-sensitivity cardiac troponin (hs-cTn) assays is a cornerstone in the clinical evaluation of patients with symptoms and/or signs of acute cardiac ischemia. To define myocardial infarction, the Universal Definition of Myocardial Infarction requires patients who manifest with features suggestive of acute myocardial ischemia to have at least one cTn concentration above the sex-specific 99th percentile upper reference limit (URL) for hs-cTn assays and a dynamic pattern of cTn concentrations to fulfill the diagnostic criteria for MI. This special report provides an overview of how hs-cTn 99th percentile URLs should be established, including recommendations about prescreening and the number of individuals required in the reference cohort, how statistical analysis should be conducted, optimal preanalytical and analytical protocols, and analytical/biological interferences or confounds that can affect accurate determination of the 99th percentile URLs. This document also provides guidance and solutions to many of the issues posed.

Item Type:	Article
Uncontrolled Keywords:	cardiac troponin, high-sensitivity cardiac troponin, 99th percentile, chest pain, diagnosis, myocardial infarction, myocardial injury, prognosis, nonischemic cardiovascular disease, normality, reference interval
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User:	Symplectic Admin
Date Deposited:	09 Nov 2022 10:21
Last Modified:	18 Jan 2023 19:43
DOI:	10.1093/clinchem/hvac092
Open Access URL:	https://doi.org/10.1093/clinchem/hvac092
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3166087