Discrepancies in potency assessment of recombinant FVIII concentrates

Haemophilia. 1998 Jul;4(4):634-40. doi: 10.1046/j.1365-2516.1998.440634.x.

Abstract

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.

Publication types

  • Review

MeSH terms

  • Biological Assay
  • Blood Coagulation Disorders / drug therapy*
  • Factor VIII / standards*
  • Factor VIII / therapeutic use
  • Humans
  • Recombinant Proteins / standards
  • Recombinant Proteins / therapeutic use
  • Reference Standards
  • World Health Organization

Substances

  • Recombinant Proteins
  • Factor VIII