Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Irsara, C; Griesmacher, A; Strasser, B; Schlagenhauf, A; Sorschag, C; Wimmer, E; Prüller, F; Cadamuro, J; Radek, J; Tomasits, J; Seier, J; Fraunberger, P; Quehenberger, P; Lirk, G; Sussitz-Rack, S; Mink, S; Haushofer, A.
Performance Evaluation of Different FIX Activity Assays for Determining Nonacog Beta Pegol (N9-GP, Refixia®) Activity Using Reagent-/Platform-Specific Conversion Factors.
Hamostaseologie. 2025;
Doi: 10.1055/a-2599-9908
PubMed
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- Führende Autor*innen der Med Uni Graz
- Haushofer Alexander
- Co-Autor*innen der Med Uni Graz
- Prüller Florian
- Schlagenhauf Axel
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- Abstract:
- Nonacog beta pegol (N9-GP) is a glycoPEGylated FIX replacement product with extended half-life for treatment of haemophilia B patients. Monitoring of N9-GP with clotting-based one-stage FIX assays is complicated by high variations, mainly due to reagent-specific interference with polyethylene glycol.In 11 distinct specialized coagulation laboratories in Austria, N9-GP spiked samples were measured in replicates in two distinct surveys, 3 years apart, using five different one-stage assay reagents and one chromogenic FIX assay. Regression analysis was used to investigate if back-calculation of N9-GP levels is feasible.We could demonstrate a linear relationship between the spiked N9-GP concentration and measured FIX activity levels for all examined assays, suggesting that N9-GP activity may be back-calculated using reagent-/platform-specific conversion factors. Within-laboratory variation after 3 years was acceptable in most, but not all, laboratories.We demonstrate that back-calculation of N9-GP activity levels may be possible when using one-stage FIX assays. However, we recommend that every laboratory ascertain its own conversion factor. When measuring real patient samples, we encourage simultaneous measurement of N9-GP spiked control material with known concentrations to ensure the validity of the current back-calculation.