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Ultra-sensitive cardiac troponins: Requirements for effective implementation in clinical practice

机译:超敏感性心肌肌钙蛋白:临床实践中有效实施的要求

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摘要

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 99th percentile of a healthy reference population, along with the percentage of “ostensibly healthy” subjects displaying measurable values < 99th 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 (i.e., “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 99th 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.
机译:心脏肌钙蛋白I或T的测定已成为怀疑急性冠脉综合征(ACS)患者,特别是非ST段抬高型心肌梗死(NSTEMI)患者临床决策的元凶。心脏肌钙蛋白免疫测定的主要分析支柱包括空白极限(LoB),检测极限(LoD),功能敏感性,健康参考人群的99 百分位数,以及“表面上健康的受试者显示可测量的值<99 th 百分位数。最新一代的心肌肌钙蛋白免疫测定法通常被定义为“高灵敏度”(HS),其特征在于,与第一项商业化技术相比,LoD降低了100倍以上,可测量值的百分比在一般健康人群中始终> 50%人口。具有进一步提高的分析灵敏度(即“超灵敏”测定)的方法的最新商业化,可以测量绝大多数健康受试者的心肌肌钙蛋白值,现在正挑战基于早期排除的诊断范式心肌肌钙蛋白值介于99 百分位数和LoD之间的受试者。因此,必须在大型多中心研究中开发并验证新的诊断策略,即特定于测定的临界值。本文的目的是提供用于测量心脏肌钙蛋白的市售HS和“超”敏感技术的最新信息,以及对评估可疑ACS患者的诊断算法日益提高的分析灵敏度可能带来的影响。

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