VON WILLEBRAND FACTOR STANDARDIZATION STUDY

几家制药商最近表示有兴趣 在获得vWF浓缩物的许可证或 他们的抗血友病因子（人）浓缩物作为治疗冯 Willebrand病 这些产品的开发带来了一些问题， 关于用于指定效价的测定的标准化， 这些产品 已组织了一项多中心研究，其中6 建议的vWF产品以盲法测定vWF：Ag， 维生素C辅因子活性（RCof）和vWF多聚体组成 使用FVIII/vWF的现行WHO血浆标准品（87/718）。 一个 评估不同实验室内和实验室间的变异性 vWF：Ag的测定（Laurell，ELISA，IRMA）和RCof的测定（肉眼， 将在收到参与者的数据后进行 labs. vWF多聚体测定的实验室间比较 也将作出。 将对数据进行分析，以确定是否存在 vWF：Ag/RCof比值与多聚体分布之间的相关性 各种产品。

Several pharmaceutical manufacturers have recently indicated an interest in obtaining a license for their vWF concentrate or an indication for their Antihemophilic Factor (Human) concentrate as treatment for von Willebrand disease. The development of such products raises issues regarding standardization of assays to be used for assigning potency to these products. A multicenter study has been organized in which 6 proposed vWF products are being assayed in blinded fashion for vWF:Ag, ristocetin cofactor activity (RCof), and vWF multimeric composition using the current WHO plasma standard for FVIII/vWF (87/718). An assessment of within and between laboratory variability for the various assays for vWF:Ag (Laurell, ELISA, IRMA) and RCof (macroscopic, aggregometer) will be made following receipt of data from participating labs. Between laboratory comparisons of vWF multimer determinations will also be made. Data will be analyzed to determine if there is any correlation between vWF:Ag/RCof ratios and multimeric distribution for the various products.