Raut Sanj, Hubbard Anthony R
Haemostasis Section, Biotherapeutics Group, National Institute for Biological Standards and Control, A Centre for the Health Protection Agency, South Mimms, Potters Bar, Hertfordshire EN63QG, UK.
Biologicals. 2010 Jul;38(4):423-9. doi: 10.1016/j.biologicals.2010.02.009. Epub 2010 Mar 24.
Measurement of coagulation factor activity using absolute physico-chemical techniques is not possible and estimation therefore relies on comparative bioassay relative to a reference standard with a known or assigned potency. However the inherent variability of locally prepared and calibrated reference standards can give rise to poor agreement between laboratories and methods. Harmonisation of measurement between laboratories at the international level relies on the availability of a common source of calibration for local reference standards and this is provided by the World Health Organization (WHO) International Standards which define the International Unit for the analyte. This article describes the principles, practices and problems of biological standardisation and the development and use of reference standards for assays of coagulation factors, with particular emphasis on WHO International Standards for both concentrates and plasma.
使用绝对物理化学技术来测量凝血因子活性是不可能的，因此评估依赖于相对于具有已知或指定效价的参考标准品的比较生物测定法。然而，本地制备和校准的参考标准品固有的变异性可能导致不同实验室和方法之间的一致性较差。国际层面实验室间测量的协调依赖于为本地参考标准品提供共同校准源，而世界卫生组织（WHO）国际标准提供了这一校准源，其定义了分析物的国际单位。本文描述了生物标准化的原理、实践和问题，以及凝血因子测定参考标准品的开发和使用，特别强调了针对浓缩物和血浆的WHO国际标准。
