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.

中文翻译：

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为高灵敏度心脏肌钙蛋白测定推导第 99 个百分位参考上限的分析考虑：IFCC 心脏生物标志物临床应用委员会的教育建议

国际临床化学联合会心脏生物标志物临床应用委员会提供循证教育文件，以促进临床实验室和实践中心脏生物标志物的统一解释和利用。该委员会的目标是提高对心脏生物标志物某些关键分析和临床方面的理解，以及这些在临床实践中如何相互作用。高灵敏度心肌肌钙蛋白 (hs-cTn) 测定的测量是临床评估有急性心肌缺血症状和/或体征的患者的基石。要定义心肌梗死，心肌梗塞的通用定义要求表现出提示急性心肌缺血特征的患者的 cTn 浓度至少高于用于 hs-cTn 测定的性别特异性第 99 个百分位参考上限 (URL) 和 cTn 浓度的动态模式满足 MI 的诊断标准。这份特别报告概述了应如何建立 hs-cTn 第 99 个百分位 URL，包括有关预筛选的建议和参考队列中所需的人数、应如何进行统计分析、最佳分析前和分析方案以及分析/生物可能影响准确确定第 99 个百分位 URL 的干扰或混淆。本文档还为所提出的许多问题提供了指导和解决方案。