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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.

 

  • References

  • 1 Winter JH, Fenech A, Bennett B, Douglas AS. Transfusion studies in patients with familial antithrombin III (At III) deficiency: half disappearance time of infused At III and influence of such infusion on platelet life-span. Br J Haem 1981; 49: 449-53.
    CrossrefPubMedGoogle Scholar
  • 2 Lechner K, Kyrle PA. Antithrombin III concentrates – Are they clinically useful?. Thromb Haemost 1995; 73 (03) 340-8.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 3 Kirkwood TBL, Barrowcliffe TW, Thomas DP. An international collaborative study establishing a reference preparation for antithrombin III. Thromb Haemost 1980; 43: 10-5.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 4 WHO Technical Report Series 1991; 814: 9
    PubMed
  • 5 Campbell PJ. International biological standards and reference preparations II: Procedures used for the production of biological standards and reference preparations. J Biol Standardisation 1974; 2: 259-67.
    PubMedGoogle Scholar
  • 6 Finney DJ. Statistical methods in biological assay. London: Charles Griffin; 1978
    Google Scholar
  • 7 Kirkwood TBL. Geometric means and measures of dispersion. Biometrics 1979; 35: 908-9.
    PubMedGoogle Scholar