Panteghini Mauro
Laboratorio Analisi Chimico Cliniche 1, Azienda Ospedaliera "Spedali Civili", 25125 Brescia, Italy.
Clin Chem Lab Med. 2004 Jan;42(1):3-8. doi: 10.1515/CCLM.2004.002.
Cardiac markers are measured by a number of different immunoassays using specific antibodies directed to the respective antigens. Lacking assay standardization, different results from different assays measuring the same marker may be obtained and this problem may cloud interpretations of reported data. Presently, there are no reference procedures for cardiac markers; certified reference materials should still be established and, at least for cardiac troponins, the analyte in the patients' blood is significantly different from newly synthesized protein. It is therefore clear that the problems of cardiac marker standardization will not be quickly solved. A number of projects are, however, underway under the auspices of the IFCC and other organizations. The aim of this opinion is to reflect on some concepts related to the implementation of a metrologically correct measurement system, giving practical examples on how these concepts can be applied to immunoassays measuring cardiac markers.
心脏标志物通过多种不同的免疫测定法进行检测，这些方法使用针对各自抗原的特异性抗体。由于缺乏测定标准化，对于同一标志物，不同的检测方法可能会得出不同的结果，这一问题可能会使报告数据的解读变得模糊。目前，尚无心脏标志物的参考程序；仍应建立经过认证的参考物质，并且至少对于心肌肌钙蛋白而言，患者血液中的分析物与新合成的蛋白质有显著差异。因此，心脏标志物标准化问题显然无法迅速得到解决。不过，在国际临床化学与检验医学联合会（IFCC）及其他组织的支持下，一些项目正在进行中。本观点的目的是思考与实施计量学正确的测量系统相关的一些概念，并给出关于如何将这些概念应用于检测心脏标志物的免疫测定法的实际示例。
