A collaborative study to establish the 1st International Standard for factor XIII plasma

Sanj Raut, R. E. Merton, P. Rigsby, L. Muszbek, R. Seitz, R. A S Ariëns, T. W. Barrowcliffe, A. Ichinose

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background: An international collaborative study, involving 23 laboratories, was carried out, under the auspices of the FXIII Standardization Working Party (SWP), to calibrate the 1st International Standard (IS) for factor XIII (FXIII) plasma. Methods: Potency estimates for the proposed candidate FXIII plasma (preparation Y: NIBSC code 02/206) were calculated relative to locally collected normal plasma pools (pool N), for both FXIII activity and antigen levels. Results: Estimates of FXIII activity potency for preparation Y showed good agreement between laboratories, with an interlaboratory geometric coefficient of variation (GCV) of 11.5% and a mean value of 0.91 U mL-1. Furthermore, there was a negligible difference in potencies by two commercially available methods, the potencies differing only by ∼1%. Estimates of FXIII antigen (A2B2 complex) potency for preparation Y showed good agreement between laboratories, with an interlaboratory GCV of 16.3% and a mean value of 0.93 U mL-1. Accelerated degradation studies showed that the proposed standard is very stable, with a predicted loss of activity (and antigen) per year of <0.06% at the recommended storage temperature of -20 °C. Conclusions: The suitability and potency of preparation Y were considered by the participants, members of the ISTH/SSC FXIII Subcommittee, the Scientific and Standardization Committee and the SWP. Following their approval, preparation Y was proposed to and accepted by the Expert Committee on Biological Standardization of the World Health Organization to be the 1st IS for FXIII plasma with an activity potency of 0.91 IU per ampoule and an antigen potency of 0.93 IU per ampoule.

Original languageEnglish
Pages (from-to)1923-1929
Number of pages7
JournalJournal of Thrombosis and Haemostasis
Volume5
Issue number9
DOIs
Publication statusPublished - Sep 2007

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Factor XIII
Antigens
Temperature

Keywords

  • Factor XIII
  • International Standard
  • Plasma

ASJC Scopus subject areas

  • Medicine(all)

Cite this

A collaborative study to establish the 1st International Standard for factor XIII plasma. / Raut, Sanj; Merton, R. E.; Rigsby, P.; Muszbek, L.; Seitz, R.; Ariëns, R. A S; Barrowcliffe, T. W.; Ichinose, A.

In: Journal of Thrombosis and Haemostasis, Vol. 5, No. 9, 09.2007, p. 1923-1929.

Research output: Contribution to journalArticle

Raut, S, Merton, RE, Rigsby, P, Muszbek, L, Seitz, R, Ariëns, RAS, Barrowcliffe, TW & Ichinose, A 2007, 'A collaborative study to establish the 1st International Standard for factor XIII plasma', Journal of Thrombosis and Haemostasis, vol. 5, no. 9, pp. 1923-1929. https://doi.org/10.1111/j.1538-7836.2007.02684.x
Raut, Sanj ; Merton, R. E. ; Rigsby, P. ; Muszbek, L. ; Seitz, R. ; Ariëns, R. A S ; Barrowcliffe, T. W. ; Ichinose, A. / A collaborative study to establish the 1st International Standard for factor XIII plasma. In: Journal of Thrombosis and Haemostasis. 2007 ; Vol. 5, No. 9. pp. 1923-1929.
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AU - Ariëns, R. A S

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