Standards for Assay of von Willebrand Factor Concentrates: A Collaborative Study

Summary

A multilaboratory collaborative study was undertaken to assess the feasibility of using a plasma standard for expressing the results of assays for the von Willebrand factor content of von Willebrand factor concentrates and of factor VIII concentrates. Thirteen laboratories tested six concentrates for von Willebrand factor antigen, ristocetin cofactor activity, and multimer content using the World Health Organization plasma standard for factor VIII/von Willebrand factor, 87/718, as a standard. Only a few assays were invalid because of nonparallelism or nonlinearity. Significant interlaboratory and interassay differences were found for both von Willebrand factor antigen and ristocetin cofactor activity. There was generally good agreement between the laboratories with respect to the multimer content in the preparations. With respect to assay validity, a plasma standard could be suitable for assaying concentrated preparations of von Willebrand factor.

• References

• 1 Dawson NJ, Kemball-Cook G, Barrowcliffe TW. Assay discrepancies with highly purified factor VIII concentrates. Haemostasis 1989; 19: 131-137
• 2 Goudemand J, Mazurier C, Marey A, Caron C, Coupez B, Mizon P, Goudemand M. Clinical and biological evaluation in von Willebrand’s disease of a von Willebrand factor concentrate with low factor VIII activity. Br J Haematol 1992; 80: 214-221
• 3 Köhler M, Hellstern P, Wenzel E. The use of heat-treated factor VIII-concentrates in von Willebrand’s disease. Blut 1985; 50: 25-27
• 4 Lamb MA, Fricke WA, Rastogi SC. Standards of factor IX: standards for “purified” factor IX concentrates. Thromb Haemostas 1991; 66: 548-551
• 5 Barrowcliffe TW, Kirkwood TBL. An international collaborative assay of factor VIII clotting activity. Thromb Haemostas 1978; 40: 260-271
• 6 Barrowcliffe TW. Comparisons of one-stage and two-stage assays of factor VIII :C. Scand J Haematol (Suppl. 00) 1984; 33: 39-54
• 7 Barrowcliffe TW, Tydeman MS, Kirkwood TBL, Thomas DP. Standardization of factor VIII-III. Establishment of a stable reference plasma for factor VIII-related activities. Thromb Haemostas 1983; 50: 690-696
• 8 Cinotti S, Longo G, Messori A, Morfini M. Reproducibility of one-stage two-stage and chromogenic assays of factor VIII activity: a multi-center study. Thromb Res 1991; 61: 385-393
• 9 Berntorp E, Nilsson IM. Biochemical and in vivo properties of commercial virus-inactivated factor VIII concentrates. Eur J Haematol 1988; 40: 205-214
• 10 Fricke WA, Yu MW. Characterization of von Willebrand factor in factor VIII concentrates. Am J Hematol 1989; 31: 41-45
• 11 Jakab T, Pflugshaupt R, Furlan M, Beck EA. Variable degradation of factor VIII-related protein in lyophilised concentrates of anti-haemophilic factor (AHF). Vox Sang 1978; 35: 36-40
• 12 Ingerslev J, Bukh A, Wallevik K, Niels PHM, Stenbjerg S. Characteristics of the von Willebrand factor in virus inactivated F VIII concentrates: the impact of heat treatment. Thromb Res 1987; 47: 175-182
• 13 Barrowcliffe TW, Kemball-Cook G, Morris G, Holt JC, Furlong RA, Peake IR. Factor VIII-related activities in therapeutic concentrates. J Lab Clin Med 1981; 97: 429-438
• 14 Burnouf-Radosevich M, Burnouf T. Chromatographic preparation of a therapeutic highly purified von Willebrand factor concentrate from human cryoprecipitate. Vox Sang 1992; 62: 1-11
• 15 Weiss HJ. The use of Cohn fraction I from diverse sources in the therapy of von Willebrand’s disease. Vox Sang 1962; 7: 97-99
• 16 Blatt PM, Brinkhous KM, Culp HR, Krauss JS, Roberts HR. Antihemophilic factor concentrate therapy in von Willebrand disease. JAMA 1976; 236: 2770-2772
• 17 Pasi KJ, Williams MD, Enayat MS, Hill FGH. Clinical and laboratory evaluation of the treatment of von Willebrand’s disease patients with heat-treated factor VIII concentrate (BPL 8Y). Br J Haematol 1990; 75: 228-233
• 18 Cumming AM, Fildes S, Cumming IR, Wensley RT, Redding OM, Burn AM. Clinical and laboratory evaluation of National Health Service factor VIII concentrate (8Y) for the treatment of von Willebrand’s disease. Br J Haematol 1990; 75: 234-239
• 19 Mazurier C, De Romeuf C, Parquet-Gernez A, Goudemand M. In vitro and in vivo characterization of a high-purity solvent/detergent-treated factor VIII concentrate: Evidence for its therapeutic efficacy in von Willebrand’s disease. Eur J Haematol 1989; 43: 7-14
• 20 Mannucci PM, Moia M, Rebulla P, Altieri D, Monteagudo J, Castillo R. Correction of the bleeding time in treated patients with severe von Willebrand disease is not solely dependent on the normal multimeric structure of plasma von Willebrand factor. Am J Hematol 1987; 25: 55-65
• 21 Mannucci PM, Tenconi PM, Castaman G, Rodeghiero F. Comparison of four virus-inactivated plasma concentrates for treatment of severe von Willebrand disease: A cross-over randomized trial. Blood 1992; 79: 3130-3137