Assay-related issues in the measurement of cardiac troponins
Assay-related issues in the measurement of cardiac troponins
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DOI：
10.1016/j.cca.2008.12.037
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发表时间：
2009-04-01
影响因子：
5
通讯作者：
Panteghini, Mauro
中科院分区：
文献类型：
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作者：
Panteghini, Mauro
全球工作组最近发布的关于心肌梗死（MI）通用定义的文件加强了心肌肌钙蛋白升高作为MI诊断主要标准的作用。尽管在临床决策中发挥着关键作用，但在日常实践中，许多与检测相关的问题仍然会显著影响检测性能。关于不精确度和分析灵敏度，商业测定的性能是可变的。此外，至少对于肌钙蛋白1，测定结果之间缺乏标准化。只有在已知并考虑了试验性能的情况下，才能确定适当的临界点（参比值分布的第99百分位数限值和/或10% CV浓度值）。待定义的关键特征包括通过适当的实验和统计方案对检测限、总不精密度和参考人群第99百分位数限值的定义进行表征。心肌肌钙蛋白测量的广泛引入是一种明显的进步，但与商业检测相比仍存在一些性能差异，大多数临床医生对此并不知情，并可能导致错误的标记物解读。(C)2009爱思唯尔有限公司版权所有。
The recently released document by the Global Task Force on the universal definition of myocardial infarction (MI) has strengthened the role of cardiac troponin increase as the main criterion for MI diagnosis. Despite this pivotal role in clinical decisions, a number of assay-related issues can still markedly affect the test performance in the everyday practice. Regarding imprecision and analytical sensitivity, the performance of commercial assays is variable. Moreover, at least for troponin 1, there is a lack of standardization among assay results. Appropriate cut points (99th percentile limit of the reference value distribution and/or 10% CV concentration value) can be established only if the assay performance is known and taken into account. Key characteristics to be defined include characterization by appropriate experimental and statistical protocols of the assay detection limit, total imprecision, and definition of the 99th percentile limit of the reference population. The widespread introduction of cardiac troponin measurements is an undoubted improvement, but some performance differences still exist with commercial assays, which most clinicians are unaware of and may give rise to wrong marker interpretation. (C) 2009 Elsevier B.V. All rights reserved.