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Thromb Haemost 1999; 82(01): 46-50
DOI: 10.1055/s-0037-1614628
Rapid Communication
Schattauer GmbH

A Collaborative Study to Establish the 2nd International Standard for Antithrombin Concentrate

Elaine Gray
1   From the National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire, UK
,
A. Dawn Walker
1   From the National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire, UK
,
Alan B. Heath
1   From the National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire, UK
› Author AffiliationsWe would like to acknowledge the donation of the antithrombin concentrate by Centeon Pharma GmbH and the contribution of all the participants of the study.
Further Information

Publication History

Received 14 August 1998

Accepted after resubmission 22 March 1999

Publication Date:
11 December 2017 (online)

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Summary

Eighteen laboratories participated in a collaborative study to calibrate a replacement for the 1st International Standard for Antithrombin, Concentrate (88/548). Excellent agreement between laboratories, as indicated by mean % gcv of 3.3 and 5.9 for functional and antigenic assays, was observed when the candidate concentrate (96/520) was assayed against the 1st International Standard for Antithrombin, Concentrate (88/548). The functional potency was found to be 7.9% (p <0.05) lower than the antigenic potency. Based on the results and with the agreement of the participants of this study and the authorisation of the Expert Committee on Biological Standardisation of the World Health Organisation, the antithrombin concentrate, coded 96/520, has been established as the 2nd International Standard for Antithrombin, Concentrate, with labelled potencies for both functional (4.7 IU/ampoule) and antigenic (5.1 IU/ampoule) activities.

 

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