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

W A Fricke; M A Lamb; S C Rastogi

doi:10.1055/s-0038-1649579

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1993; 70(02): 351-356
DOI: 10.1055/s-0038-1649579

Original Articles

Platelets

Schattauer GmbH Stuttgart

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

Authors

W A Fricke

The U. S. Food and Drug Administration, Center for Biologics Evaluation and Research, Bethesda, MD, USA
M A Lamb

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

Abstract

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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.

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References

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