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Performance Evaluation of Different FIX Activity Assays for Determining Nonacog Beta Pegol (N9-GP, Refixia) Activity

Christian Irsara1,2, Andrea Griesmacher1,2,3, Bernhard Strasser2,4

  • 1Central Institute of Medical and Chemical Laboratory Diagnostics (ZIMCL), University Hospital of Innsbruck, Innsbruck, Austria.

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|August 29, 2025
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Monitoring nonacog beta pegol (N9-GP) in haemophilia B patients using clotting assays is challenging. This study shows N9-GP levels can be back-calculated using specific conversion factors for one-stage FIX assays.

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Area of Science:

  • Coagulation science
  • Pharmacokinetics
  • Biotechnology

Background:

  • Nonacog beta pegol (N9-GP) is an extended half-life glycoPEGylated Factor IX (FIX) replacement therapy for haemophilia B.
  • Clotting-based one-stage FIX assays exhibit high variability in monitoring N9-GP, primarily due to polyethylene glycol interference.

Purpose of the Study:

  • To investigate the feasibility of back-calculating N9-GP levels using one-stage FIX assays.
  • To assess the reproducibility of N9-GP measurements across different laboratories and reagents over time.

Main Methods:

  • N9-GP spiked samples were analyzed in 11 Austrian coagulation laboratories across two surveys, 3 years apart.
  • Five different one-stage FIX assay reagents and one chromogenic FIX assay were utilized.
  • Regression analysis was performed to establish relationships between spiked concentrations and measured FIX activity.

Main Results:

  • A linear relationship was observed between spiked N9-GP concentration and measured FIX activity for all tested assays.
  • Reagent- and platform-specific conversion factors may enable back-calculation of N9-GP activity.
  • Within-laboratory variation was generally acceptable over the 3-year period, though not universally consistent.

Conclusions:

  • Back-calculation of N9-GP activity levels is feasible with one-stage FIX assays, provided laboratory-specific conversion factors are determined.
  • Laboratories should establish their own conversion factors for accurate N9-GP monitoring.
  • Simultaneous measurement of N9-GP spiked controls is recommended for validating results from patient samples.