Assay discrepancies with highly purified factor VIII concentrates

Abstract

We have assayed two different monoclonal-antibody-purified concentrates (A and B) and one conventional concentrate (C), against the 3rd International Standard for factor VIII concentrate, using one-stage, two-stage and chromogenic methods. One-stage assays performed with immunodepleted plasmas gave lower potencies than with haemophilic plasma for all concentrates, though the discrepancies were most marked for the two highly purified products. The absence of von Willebrand factor in one of the immunodepleted plasmas appeared to contribute towards the low potencies observed. In addition, potencies of product A were 50% higher by one-stage assays (haemophilic plasma) than by two-stage or chromogenic methods. These results indicate the need for careful evaluation of assay methodologies for assessment of factor VIII:C activity in highly purified concentrates.