Hubbard A R
Division of Haematology, National Institute for Biological Standards and Control, Potters Bar, Herts, UK.
Thromb Haemost. 1997 Oct;78(4):1237-41.
An international collaborative study, involving 16 laboratories, was carried out to calibrate the 1st International Standard Protein S, plasma, for total and free Protein S antigen and for Protein S function. Potency estimates were calculated relative to locally collected fresh normal plasma pools. Estimates of total Protein S antigen showed good agreement between laboratories with inter-laboratory geometric coefficient of variation (gcv%) of 8.8% and a mean value of 0.89 IU/ampoule. Estimates of free Protein S antigen calculated relative to total Protein S antigen in the fresh normal pools were more variable (gcv 26.8%) than estimates calculated relative to free Protein S antigen (gcv 15.3%); the latter comparison was used for calibration with a mean value of 0.89 IU/ampoule. Functional Protein S was estimated using commercial kits which gave an overall mean value of 0.92 IU/ampoule (gcv 14.0%). The 1st International Standard Protein S, plasma, (coded 93/590) was established in October 1995 with a single potency of 0.90 IU/ampoule for all three parameters.
一项涉及16个实验室的国际合作研究开展，旨在对第一国际标准血浆蛋白S进行总蛋白S抗原、游离蛋白S抗原及蛋白S功能的校准。效价估计是相对于本地收集的新鲜正常血浆池计算得出的。总蛋白S抗原的估计值在各实验室之间显示出良好的一致性，实验室间几何变异系数（gcv%）为8.8%，平均值为0.89 IU/安瓿。相对于新鲜正常血浆池中总蛋白S抗原计算得出的游离蛋白S抗原估计值，比相对于游离蛋白S抗原计算得出的估计值更具变异性（gcv 26.8%）；后一种比较用于校准，平均值为0.89 IU/安瓿。使用商业试剂盒估计功能性蛋白S，其总体平均值为0.92 IU/安瓿（gcv 14.0%）。第一国际标准血浆蛋白S（编码93/590）于1995年10月建立，所有三个参数的单一效价均为0.90 IU/安瓿。
