Section of Clinical Biochemistry, University of Verona, Verona, Italy.
Leon H. Charney Division of Cardiology, New York University School of Medicine, New York, USA.
Biochem Med (Zagreb). 2018 Oct 15;28(3):030501. doi: 10.11613/BM.2018.030501.
The measurement of cardiac troponins, either cardiac troponin I or T, has become the culprit of clinical decision making in patients with suspected acute coronary syndrome (ACS), especially in those with non-ST elevation myocardial infarction (NSTEMI). The leading analytical mainstays of cardiac troponin immunoassays include the limit of blank (LoB), limit of detection (LoD), functional sensitivity, the 99 percentile of a healthy reference population, along with the percentage of "ostensibly healthy" subjects displaying measurable values < 99 percentile. The latest generation of cardiac troponin immunoassays, conventionally defined as "high-sensitive" (HS), is characterized by a LoD over 100-fold lower compared to the first commercialized techniques and a percentage of measurable values consistently > 50% in the general healthy population. The very recent commercialization of methods with further improved analytical sensitivity (, "ultra-sensitive" assays), which allow to measure cardiac troponin values in the vast majority of healthy subjects, is now challenging the diagnostic paradigm based on early rule-out of subjects with cardiac troponin values comprised between the 99 percentile and LoD. New diagnostic strategies, entailing assay-specific cut-offs, must hence be developed and validated in large multicenter studies. The aim of this article is to provide an update on commercially available HS and "ultra"-sensitive techniques for measuring cardiac troponins, along with possible implications of increasingly enhanced analytical sensitivity on diagnostic algorithms for evaluating patients with suspected ACS.
心肌肌钙蛋白的测量，无论是心肌肌钙蛋白 I 还是 T，已经成为疑似急性冠状动脉综合征（ACS）患者临床决策的关键因素，尤其是在非 ST 段抬高型心肌梗死（NSTEMI）患者中。心肌肌钙蛋白免疫分析的主要分析支柱包括空白限（LoB）、检测限（LoD）、功能灵敏度、健康参考人群的第 99 百分位数，以及显示可测量值<99 百分位数的“看似健康”受试者的百分比。最新一代的心肌肌钙蛋白免疫分析通常被定义为“高灵敏度”（HS），与第一批商业化技术相比，其 LoD 低了 100 多倍，并且在一般健康人群中，可测量值的百分比始终>50%。最近，方法的商业化进一步提高了分析灵敏度（“超灵敏”测定法），这使得能够测量绝大多数健康受试者的心肌肌钙蛋白值，现在正在挑战基于将心肌肌钙蛋白值介于第 99 百分位数和 LoD 之间的患者进行早期排除的诊断范式。因此，必须在大型多中心研究中开发和验证基于检测的特定临界点的新诊断策略。本文的目的是提供关于商业化的 HS 和“超灵敏”技术测量心肌肌钙蛋白的最新信息，以及分析灵敏度的提高对评估疑似 ACS 患者的诊断算法可能产生的影响。
