• Sanj Raut and Anthony R Hubbard.
• 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. Sanj.Raut@nibsc.hpa.org.uk
• Biologicals. 2010 Jul 1; 38 (4): 423-9.

AbstractMeasurement 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.Crown Copyright 2010. Published by Elsevier Ltd. All rights reserved.

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