Barrowcliffe T W, Raut S, Hubbard A R
NIBSC, Potters Bar, UK.
Haemophilia. 1998 Jul;4(4):634-40. doi: 10.1046/j.1365-2516.1998.440634.x.
Results of assays of recombinant FVIII concentrates have been reviewed over a 10-year period. Initially there was wide variability between laboratories but this was minimised by the development of standardised assay methodology, in particular the use of haemophilic plasma for pre-dilution and 1% albumin in assay buffers. Using this standardised methodology and concentrate standards, there were no major differences in potency between one-stage, two-stage and chromogenic assays on the two full-length recombinant FVIII concentrates. However, using a plasma standard, the chromogenic method gave much higher potencies than the one-stage method on the same concentrates, and this explains a similar discrepancy found in patients' post-infusion samples after injection of recombinant concentrates. It is suggested that concentrate standards be used for such post-infusion samples in order to minimise this discrepancy.
对重组FVIII浓缩物的检测结果进行了为期10年的回顾。最初，各实验室之间存在很大差异，但通过开发标准化检测方法，特别是在检测缓冲液中使用血友病血浆进行预稀释和1%白蛋白，这种差异被最小化。使用这种标准化方法和浓缩物标准品，两种全长重组FVIII浓缩物的一步法、两步法和发色底物法检测效力之间没有重大差异。然而，使用血浆标准品时，发色底物法对相同浓缩物的检测效力比一步法高得多，这解释了注射重组浓缩物后患者输注后样本中发现的类似差异。建议对这类输注后样本使用浓缩物标准品，以尽量减少这种差异。
