Thelwell C
Biotherapeutics, Haemostasis Section, National Institute for Biological Standards and Control, South Mimms EN63QG, UK.
Biologicals. 2010 Jul;38(4):437-48. doi: 10.1016/j.biologicals.2010.02.006. Epub 2010 Mar 23.
Biological standards are used to calibrate measurements of components of the fibrinolytic system, either for assigning potency values to therapeutic products, or to determine levels in human plasma as an indicator of thrombotic risk. Traditionally WHO International Standards are calibrated in International Units based on consensus values from collaborative studies. The International Unit is defined by the response activity of a given amount of the standard in a bioassay, independent of the method used. Assay validity is based on the assumption that both standard and test preparation contain the same analyte, and the response in an assay is a true function of this analyte. This principle is reflected in the diversity of source materials used to prepare fibrinolysis standards, which has depended on the contemporary preparations they were employed to measure. With advancing recombinant technology, and improved analytical techniques, a reference system based on reference materials and associated reference methods has been recommended for future fibrinolysis standards. Careful consideration and scientific judgement must however be applied when deciding on an approach to develop a new standard, with decisions based on the suitability of a standard to serve its purpose, and not just to satisfy a metrological ideal.
生物标准用于校准纤维蛋白溶解系统各成分的测量，既可为治疗产品赋予效价，也可测定人体血浆中的水平，作为血栓形成风险的指标。传统上，世界卫生组织国际标准是根据合作研究的共识值以国际单位进行校准的。国际单位由生物测定中给定数量标准品的反应活性定义，与所使用的方法无关。测定有效性基于这样的假设，即标准品和测试制剂都含有相同的分析物，并且测定中的反应是该分析物的真实函数。这一原则体现在用于制备纤维蛋白溶解标准品的源材料的多样性上，这取决于它们所用于测量的当代制剂。随着重组技术的进步和分析技术的改进，已建议为未来的纤维蛋白溶解标准品建立基于参考物质和相关参考方法的参考系统。然而，在决定制定新标准的方法时，必须进行仔细考虑和科学判断，决策应基于标准是否适合其用途，而不仅仅是为了满足计量理想。
