Download PDF
Thromb Haemost 1991; 66(05): 548-551
DOI: 10.1055/s-0038-1646457
Original Article
Schattauer GmbH Stuttgart

Standardization of Factor IX: Standards for "Purified" Factor IX Concentrates

M A Lamb
The U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Bethesda, MD, USA
,
W A Fricke
The U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Bethesda, MD, USA
,
S C Rastogi
The U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Bethesda, MD, USA
› Author Affiliations
Further Information

Publication History

Received 29 January 1991

Accepted 07 May 1991

Publication Date:
25 July 2018 (online)

Also available at
  PDF Download  Permissions and Reprints

Summary

An international collaborative study was carried out to determine the suitability of the current WHO II-IX-X concentrate standard, 84/681, for assigning potency to the more highly purified factor IX concentrates. Three Coagulation Factor IX (Human) preparations and one Factor IX Complex preparation were assayed by the one stage method against WHO 84/681 following predilution to 1.0 u/ml in buffer, 1% albumin, or factor IX deficient plasma.

There were no cases of non-parallelism between any of the preparations and the current WHO standard. Predilution of the Coagulation Factor IX (Human) preparations in 1% albumin or factor IX deficient plasma gave similar potency values. Predilution in buffer gave significantly lower (p <0.01) potency values. For the Factor IX Complex preparation, potency estimates were significantly different (p <0.01) with each prediluent. The overall precision was similar within each predilution for all preparations with predilution in buffer being less precise than predilution in albumin or in deficient plasma.

WHO standard 84/681 appears to be a suitable standard for the potency determination of the more highly purified factor IX preparations. Predilution in 1% albumin or factor IX deficient plasma is recommended as they give equivalent results with the least variability.

 

  • References

  • 1 Standardization of factors II, VII, IX and X in plasma and concentrates - Report of the ICTH Subcommittee on factors VIII and IX, Brussels 1987. Thromb Haemostas 1988; 59 (2) 334
    PubMedSearch in Google Scholar
  • 2 World Health Organization Techn Rep Ser. 1988; 771: 23
    PubMedSearch in Google Scholar
  • 3 Aronson DL, Thomas DR. The control and standardization of factor VIII. Scand J Haematol 1984; 33 (Supp41) 71-8
    PubMedSearch in Google Scholar
  • 4 Barrowcliffe TW, Thomas DR. The provisions of standards for blood coagulation factors. In: Recent Advances in Blood Coagulation.. Poller L. (ed) Churchill Livingstone, Edinburgh: 1985. pp 251-66
    Search in Google Scholar
  • 5 Barrowcliffe TW. Standardization of assays of factor VIII and factor IX. Res Clin Lab 1990; 20: 155-65
    PubMedSearch in Google Scholar
  • 6 Barrowcliffe TW, Tydeman MS, Kirkwood TBL. Major effects of prediluent in factor IX clotting assay. Lancet 1979; 2: 192
    PubMedSearch in Google Scholar
  • 7 Brownlee KA. Statistical Theory and Methodology in Science and Engineering. 2nd edition. John Wiley & Sons, Inc., New York: 1966
    Search in Google Scholar
  • 8 Snedecor GW, Cochran WG. Statistical Methods. 8th edition. Iowa State University Press, Ames, IA: 1989
    Search in Google Scholar
  • 9 Sokal RR, Rohlf FJ. Biometry. Freeman & Co., San Francisco, CA: 1969
    Search in Google Scholar
  • 10 Baxter Healthcare Corporation Product circular for Factor IX Complex, Heat Treated, Proplex®T. 1988
    PubMedSearch in Google Scholar
  • 11 Christensen RL, Triplett DA. Factor assay (VIII and IX) results in the College of American Pathologists Survey Program (1980-1982). Am J Clin Pathol 1983; 80 (Supp) 633-42
    PubMedSearch in Google Scholar
  • 12 Brandt JT, Triplett DA, Musgrave K, Arkin C, Bovill EG, Lucas FV, Rock WA. Factor VIII assays. Assessment of variables. Arch Pathol Lab Med 1988; 112: 7-12
    PubMedSearch in Google Scholar