Solution for Hemophilia management

Solution for Hemophilia management 
 
Optimized assays for accompanying the various FVIII and FIX prophylactic or on demand treatments for Hemophilia:
  • Monitoring of prophylaxis with new recombinant or long acting products, according to individual drug kinetics and clinical contexts: therapy adjustment in treated patients, optimizing delay between injections.
  • Homogenous reactivity of chromogenic assays with the various existing and new blood extracted, recombinant (regardless the structure), and long acting (pegylated, glycopegylated, or Fc/albumin fusion proteins) products.
  • Use of a single calibrator, established against the WHO International Standards (NIBSC, Potters Bar, UK).
  • Reliable & robust assays designed with only human
  • highly purified factors
  • Validated method applications for the various major laboratory instruments
 
Hemophilia diagnosis & Monitoring of replacement therapy

 
Chromogenic assay for measuring Factor VIII:C activity in human citrated plasma or in Factor VIII:C therapeutic concentrates.
  • Working range : 0.25 – 250 %
  • Highly performing nt in case of mild & moderate H
  • Insensibility to presence of lupus-like anticoagulant2 and Heparin.
  • Recommended for the monitoring treatments with recombinant products.3,4
  • Validated applications for ACL TOP, BCS XP, Sysmex CS & STA-R.
 
 

 
Chromogenic assay for measuring Factor IX activity in human citrated plasma or in Factor IX therapeutic concentrates.
  • Working range : 0.75 – 250 %
  • Insensibility to presence of Heparin.
  • Recommended for the monitoring of treatments using recombinant products.4
  • Validated applications for ACLTOP, BCSXP, Sysmex CS & STAR.
 

Measurement of FVIII:C antibodies by ELISA
 
Monitoring of treatments for patients with acquired resistance to replacement therapy

Clotting assay for quantitative measuring the activated Factor VII activity in human citrated plasma or in Factor VIIa therapeutic concentrates.
  • Applications on Sysmex CS & STAR.
 
References:
1Trossaert M, Boisseau P, Quemener A, Sigaud M, Fouassier M, Ternisien C, Lefrancois-Bettembourg A, Tesson C, Thomas C, Bezieau S. Prevalence, biological phenotype and genotype in moderate/mild hemophilia A with discrepancy between one-stage and chromogenic factor VIII activity. J Thromb Haemost 2011; 9: 524–30.
2De Maistre E, Wahl D, Perret-Guillaume C, Regnault V, Clarac S, Briquel ME, et al. A chromogenic assay allows reliable measurement of factor VIII levels in the presence of strong lupus anticoagulants. Thromb Haemost. janv 1998;79(1):237‑238.
3Mikaelsson M, Oswaldsson U. Assaying the circulating factor VIII activity in hemophilia A patients treated with recombinant factor VIII products. Semin Thromb Hemost. Juin 2002; 28(3):257‑264.
4Kitchen S, Gray E, Mertens K. Monitoring of modified factor VIII & IX products. Haemophilia 2014, 20 – 36-42.
5Werwitzke S, Geisen U, Nowak-Göttl U, Eichler H, Stephan B, Scholz U, Holstein K, Klamorth R, Knöbl P, Huth-¨Kühne A, Bomke B, Tiede A. Diagnostic and prognostic value of factor VIII binding antibodies in acquired hemophilia A: data from the GTH-AH 01/2010 study. J Thromb Haemost. 2016 May;14(5):940-7