Mire-Sluis A R, Padilla A, Das R G
National Institute for Biological Standards and Control, Hertfordshire, UK.
Dev Biol Stand. 1999;97:171-6.
To quantify the biological activity of different cytokine preparations with different specific activities by bioassay, mass units cannot be used and biological activity has to be expressed as << biological potency units >>. The biological unit requires definition by a standard that is assay-independent (especially when measuring a particular type of biological activity). Once the unit is defined, it can be used in any laboratory, thus providing a means of ensuring uniformity throughout the world in the designation of potency of different biological preparations. The World Health Organisation (WHO) standardization programme involves the production of biologically stable, well-characterised potency and immunoassay standards that are available world-wide using a single international unitage. These international standards have been used to reduce dramatically the variation in estimates of cytokine preparations within and between laboratories for immunoassays and bioassays.
通过生物测定来量化具有不同比活性的不同细胞因子制剂的生物活性时,不能使用质量单位,生物活性必须表示为“生物效价单位”。生物单位需要通过一个与测定方法无关的标准来定义(特别是在测量特定类型的生物活性时)。一旦定义了该单位,它就可以在任何实验室中使用,从而提供一种确保全世界不同生物制剂效价指定一致性的方法。世界卫生组织(WHO)的标准化计划涉及生产生物稳定、特性明确的效价和免疫测定标准品,这些标准品使用单一国际单位制在全球范围内提供。这些国际标准已被用于大幅减少免疫测定和生物测定中不同实验室内部和之间细胞因子制剂估计值的差异。