COAGULATION FACTOR IX STANDARDIZATION STUDY

开展了一项国际合作研究，以确定 现行世卫组织II-IX-X浓缩标准的适用性，84/681， 为更高纯度的凝血因子IX赋予效力 浓缩液。三种凝血因子IX(人)制剂和一种 一步法测定因子IX复合制剂的含量 在缓冲液中预稀释至1.0u/ml后，对WHO 84/681，1% 白蛋白，或凝血因子IX缺乏的血浆。 两种制剂之间没有出现不平行的情况。 和目前世界卫生组织的标准。凝血因子IX的预稀释 (人)在1%白蛋白或凝血因子IX缺乏的血浆中制备 相似的效能值。缓冲液中的预稀释显著降低了 (P&lt；0.01)效能值。对于凝血因子IX复合制剂，效力 每种预稀释剂的估算值都有显著差异(p&lt；0.01)。 在每个预稀释内，所有样品的总体精密度相似 在缓冲液中预稀释的制剂的精密度低于 在白蛋白或缺乏血浆中预稀释。 世卫组织标准84/681似乎是一个适合效力的标准 纯度较高的凝血因子IX制剂的测定。 建议在1%白蛋白或凝血因子IX缺乏的血浆中预稀释 因为它们以最小的变异性给出了相同的结果。

An international collaborative study was carried out to determine the suitability of the current WHO II - IX - X concentrate standard, 84/681, for assigning potency to the more highly purified Factor IX concentrates. Three Coagulation Factor IX (Human) preparations and one Factor IX Complex preparation were assayed by the one stage method against WHO 84/681 following predilution to 1.0 u/ml in buffer, 1% albumin, or factor IX deficient plasma. There were no cases of non-parallelism between any of the preparations and the current WHO standard. Predilution of the Coagulation Factor IX (Human) preparations in 1% albumin or factor IX deficient plasma gave similar potency values. Predilution in buffer gave significantly lower (P<0.01) potency values. For the Factor IX Complex preparation, potency estimates were significantly different (p<0.01) with each prediluent. The overall precision was similar within each predilution for all preparations with predilution in buffer being less precise than predilution in albumin or in deficient plasma. WHO standard 84/681 appears to be a suitable standard for the potency determination of the more highly purified factor IX preparations. Predilution in 1% albumin or factor IX deficient plasma is recommended as they give equivalent results with the least variability.