供应NIBSC09/182可溯源国际标准物质血管性血友病因子VWF
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The WHO 2nd International Standard (IS) for von Willebrand Factor,Concentrate was established by the Expert Committee on Biological Standardisation of the World Health Organisation in October 2010. The preparation consists of glass sealed ampoules (coded 09/182) containing 1 ml aliquots of von Willebrand factor concentrate, freeze-dried. The WHO 2nd IS is intended to be used for the estimation of von Willebrand factor in therapeutic concentrates via the calibration of working standards,such as manufacturers’ “in house” standards. The WHO 2nd IS has assigned values for the following analytes: NIBSC09/182
von Willebrand factor: antigen – VWF:Ag
von Willebrand factor: ristocetin cofactor – VWF:RCo
von Willebrand factor: collagen binding – VWF:CB 可溯源国际标准物质血管性血友病因子VWF
Further details on the preparation and the collaborative study can be
found in the WHO document WHO/BS/10.2147. This preparation is not for administration to humans or animals in the human food chain.The preparation contains material of human origin, and either the final product or the source materials, from which it is derived, have been tested and found negative for HBsAg, anti-HIV and HCV RNA. As with all materials of biological origin, this preparation should be regarded as potentially hazardous to health. It should be used and discarded according to your own laboratory’s safety procedures. Such safety procedures should include the wearing of protective gloves and avoiding the generation of aerosols. Care should be exercised in opening ampoules or vials, to avoid cuts.
生物药物比化学合成药物更复杂。在大多数情况下，它们不能单独使用标准物理化学方法进行表征和测量，因此必须使用生物测定来测量它们的生物活性。生物测定是为了测定复杂混合物中生物活性物质的含量而进行的测试。他们测量它对生物化学过程或生物系统（如细胞、组织或活体）的影响。
世界卫生组织（WHO）生物参考材料（世界卫生组织国际标准和参考材料）提供了一套通用标准，用于确保全球生物药品的质量。
这些国际标准被认为是“黄金标准”，区域、国家和国际实验室和制造商根据这些标准校准自己的工作标准。它们是以生物活性为单位进行校准的，这些生物活性是在涉及多个国际实验室的广泛研究之后分配的。
由于生物测定使用复杂的生物系统来测试活性，因此它们在不同的测试中是可变的。通过使用已知活性或效力的生物参考材料或标准品，无论何时何地进行生物测定，都可以对生物测定结果进行比较和校准，以给出一致的结果。
在诊断测试的情况下，使用已知活性的对照样品可以监测测试系统的灵敏度和特异性，并确保质量。