FVIII activity measurement in patients with severe haemophilia A treated with EHL concentrates – selected assays results comparison

Authors

  • Marie Prudkova Oddělení klinické hematologie, FN Brno; Interní hematologická a onkologická klinika LF MU a FN Brno; Katedra laboratorních metod LF MU, Brno
  • Petr Smejkal Oddělení klinické hematologie FN Brno; Katedra laboratorních metod LF MU, Brno
  • Dagmar Chytrá Oddělení klinické hematologie FN Brno; Katedra laboratorních metod LF MU, Brno
  • Jiřina Zavřelová Oddělení klinické hematologie FN Brno; Katedra laboratorních metod LF MU, Brno
  • Gabriela Romanová Oddělení klinické hematologie, FN Brno; Interní hematologická a onkologická klinika LF MU a FN Brno; Katedra laboratorních metod LF MU, Brno
  • Miroslav Penka Oddělení klinické hematologie, FN Brno; Interní hematologická a onkologická klinika LF MU a FN Brno
  • Alena Buliková Oddělení klinické hematologie, FN Brno; Interní hematologická a onkologická klinika LF MU a FN Brno

Keywords:

haemophilia A, FVIII activity, EHL concentrates

Abstract

Introduction: The optimal substitutional treatment includes the FVIII activity (FVIII:C) measurement by the one-stage clotting assay (OSA) or chromogenic substrate assay (CSA). However, with the advent of FVIII concentrates with an extended half-life, the problem of discrepancy between methods got worse due to the modifications of the FVIII molecule.

Aim: Evaluation of the OSA and CSA discrepancy in patients treated with extended half-life FVIII concentrates.

Method: The FVIII:C measurement by OSA with reagents Cephascreen® (Diagnostica Stago) and Pathromtin® SL (Siemens Healthineers) and by CSA BIOPHENTM FVIII:C (Hyphen BioMed) in patients treated with efmoroctocog alfa, rurioctocog alfa pegol, turoctocog alfa pegol and damoctocog alfa pegol.

Results: The OSA and CSA results correlated with a good outcome for efmoroctocog alfa, the differences were up to 21 %. The results of rurioctocog alfa pegol in the range of 15–200 % were slightly lower by OSA with both reagents, on an average by 11 % and 18 %, while the results up to 10 % were higher by OSA with an average difference 54 % for Cephascreen® and up to 75 % for Pathromtin® SL. The resulst of turoctocog alfa pegol were lower by OSA in the range of 15–200 %, on an average by 36 % and 25 %. The samples with FVIII:C above 10 % of damoctocog alfa pegol were slightly higher by OSA (Cephascreen® by 18 %), but samples up to 10 % were significantly higher, with Cephascreen® on an average by 91 % and by 100 % with Pathromtin® SL.

Conclusions: OSA Cephascreen® or Pathromtin® SL and CSA Hyphen correlate with a good outcome for efmoroctocog alfa. Of the other concentrates, the results correlate with a good outcome only for rurioctocog alfa pegol and damoctocog alfa pegol, and only the results of FVIII:C > 10 %.

Published

2024-12-18