供应WHO07/316可溯源血浆中凝血因子VIII和血管性血友病因子国际标准物质

供应WHO07/316可溯源血浆中凝血因子VIII和血管性血友病因子国际标准物质

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The WHO 6th International Standard for Factor VIII and von Willebrand Factor in plasma was established by the Expert Committee on Biological Standardisation of the World Health Organisation in October 2009 and details of the preparation and value assignment are available in document WHO/BS/09.2116. Assignment of a value for an additional analyte, von Willebrand factor propeptide, was agreed by WHO ECBS in October 2011 as described in document WHO/BS/11.2171. This preparation also serves as the International Reference Reagent for methods measuring VWF binding to recombinant Glycoprotein Ib which are ristocetin-dependent (VWF:GPIbR) or rely on a gain-of-function mutation of GPIb (VWF:GPIbM) and values were assigned in October 2018 as described in document WHO/BS/2018.2337. The preparation consists of glass ampoules (coded 07/316) containing 1 ml aliquots of pooled normal human plasma, freeze-dried. This preparation coded 07/316 has values assigned for the following analytes: WHO07/316

Factor VIII Clotting activity – FVIII:C

Factor VIII Antigen – FVIII:Ag

von Willebrand Factor Antigen – VWF:Ag

von Willebrand Factor Ristocetin Cofactor function – VWF:RCo

VWF binding to recGPIb – ristocetin-dependent – VWF:GPIbR

VWF binding to recGPIb – gain-of-function mutant – VWF:GPIbM

von Willebrand Factor Collagen Binding function – VWF:CB 可溯源血浆中凝血因子VIII和血管性血友病因子国际标准物质

von Willebrand Factor Propeptide – VWFpp

The standard is intended to be used for the estimation of these analytes in human plasma. For the estimation of FVIII:C in therapeutic concentrates it is recommended that the current WHO International Standard Factor VIII Concentrate is used. For the estimation of VWF:Ag, VWF:CB and VWF:RCo in therapeutic concentrates it is recommended that the current WHO International Standard von Willebrand Factor Concentrate is used.

世界卫生组织生物标准化专家委员会于2009年10月制定了血浆中因子VIII和von Willebrand因子的第六个国际标准,有关制备和赋值的详细信息,请参阅文件世界卫生组织/BS/09.2116。如文件世界卫生组织/BS/11.2171所述,世界卫生组织欧洲委员会于2011年10月同意为附加分析物von Willebrand因子前肽赋值。该制剂还可作为国际参考试剂,用于测量VWF与重组糖蛋白Ib结合的方法,这些重组糖蛋白是ristocetin依赖性的(VWF:GPIbR)或依赖于GPIb的获得性突变(VWF:GPIbM),如文件世界卫生组织/BS/2018.2337所述,这些值于2018年10月赋值。该制剂由玻璃安瓿(编码07/316)组成,其中含有1毫升冷冻干燥的合并正常人血浆等分试样。该制剂编号07/316,具有以下分析物的赋值:

因子VIII凝血活性-FVIII:C

因子VIII抗原-FVIII:Ag

血管性血友病因子抗原-VWF:Ag

von Willebrand因子Ristocetin协同作用-VWF:RCo

VWF与recGPIb的结合-瑞司汀依赖性-VWF:GPIbR

VWF与recGPIb结合-功能获得突变体-VWF:GPIbM

血管性血友病因子胶原结合功能-VWF:CB

von Willebrand因子原肽-VWFpp

本标准旨在用于估计人体血浆中的这些分析物。为了估算治疗浓缩物中的FVIII:C,建议使用当前的世界卫生组织国际标准VIII因子浓缩物。为了估算治疗浓缩物中的VWF:Ag、VWF:CB和VWF:RCo,建议使用当前世界卫生组织国际标准的血管性血友病因子浓缩物。