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Abstract

Assays of Factor VIII in clinical laboratories are subject to large variability and one of the sources of this variability is the wide range of reference plasmas used. An International Standard for Factor VIII in plasma is available from WHO but only in limited quantity. The aim of this project was to establish a European Reference Plasma for Factor VIII, carefully calibrated against the WHO standard in a large collaborative study, in order to improve quality control in European laboratories.

The European Reference Plasma for Factor VIII (BCR-629) consists of lyophilised normal human plasma, pooled from 17 donors, in sealed glass ampoules. Prior to pooling and ampouling the plasmas were centrifuged twice and buffered in order to enhance stability, according to previous studies.

BCR-629 has been calibrated for FVIII relative to the primary WHO International Standard for FVIII in plasma (3rd International Standard Factor VIII/vWF, plasma code 91/666) in a collaborative study involving 14 laboratories in 10 countries. There was good agreement between laboratories and between the 1-stage and chromogenic assay methods. Preliminary stability studies based on accelerated degradation predicted satisfactory long term stability for the standard when stored at �20 C, but further monitoring of stability in real time will be performed.

The results of the calibration study indicated that preparation BCR-629 is suitable to serve as the European Reference Plasma for Factor VIII

Additional information

Authors: BARROWCLIFFE T W, National Institute for Biological Standards and Control, Hertfordshire (GB);HUBBARD A R, National Institute for Biological Standards and Control, Hertfordshire (GB);WELLER J, National Institute for Biological Standards and Control, Hertfordshire (GB);MACNAB J, National Institute for Biological Standards and Control, Hertfordshire (GB);BENNINK D, European Commission, DG Research, Standards, Measurement and Testing, Brussels (BE);GAWLIK B M, European Commission DG Joint Research Centre;KLEIN C L, European Commission DG Joint Research Centre;LAMBERTY A, European Commission DG Joint Research Centre
Bibliographic Reference: EUR 21061 EN (2004), 25 pp. Free of charge
Availability: Available from European Commission, JRC Knowledge Management Unit, Ispra (IT) Tel: +39 033278 9893 Fax: +39 033278 5409 E-mail: jrc-publications-office@ec.europa.eu or Bruxelles (BE) Tel: +32 2 295 76 24 Fax: +32 2 299 63 22
ISBN: ISBN: 92-894-5173-4
Record Number: 200417513 / Last updated on: 2004-06-01
Category: PUBLICATION
Original language: en
Available languages: en