Panteghini Mauro
Department of Clinical Sciences Luigi Sacco, University of Milan Medical School, Milan, Italy.
Clin Chim Acta. 2009 Apr;402(1-2):88-93. doi: 10.1016/j.cca.2008.12.037. Epub 2009 Jan 9.
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 I, 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.
全球心肌梗死(MI)通用定义特别工作组最近发布的文件强化了心肌肌钙蛋白升高作为MI诊断主要标准的作用。尽管其在临床决策中发挥着关键作用,但一些与检测方法相关的问题在日常实践中仍会显著影响检测性能。在不精密度和分析灵敏度方面,商业检测方法的性能参差不齐。此外,至少对于肌钙蛋白I,检测结果之间缺乏标准化。只有在了解并考虑检测方法性能的情况下,才能确定合适的临界值(参考值分布的第99百分位数限值和/或10%变异系数浓度值)。需要定义的关键特性包括通过适当的实验和统计方案对检测方法的检测限、总不精密度以及参考人群第99百分位数限值进行表征。心肌肌钙蛋白检测的广泛应用无疑是一项进步,但商业检测方法之间仍存在一些性能差异,大多数临床医生并不知晓,这可能导致对标志物的错误解读。