Evaluation of N8-GP Activity Using a One-Stage Clotting Assay: A Single-Center Experience.

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  • Additional Information
    • Source:
      Publisher: Karger Country of Publication: Switzerland NLM ID: 0141053 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1421-9662 (Electronic) Linking ISSN: 00015792 NLM ISO Abbreviation: Acta Haematol Subsets: MEDLINE
    • Publication Information:
      Original Publication: Basel, Karger.
    • Subject Terms:
      Blood Coagulation Tests/*methods ; Factor VIII/*analysis ; Hemophilia A/*pathology; Adult ; Factor VIII/therapeutic use ; Hemophilia A/blood ; Hemophilia A/drug therapy ; Humans ; Male ; Middle Aged
    • Abstract:
      N8-GP (ESPEROCT®; turoctocog alfa pegol; Novo Nordisk A/S, Bagsvaerd, Denmark) is an extended half-life recombinant factor VIII (FVIII) molecule. FVIII-deficient plasma spiked with N8-GP can be accurately measured using many activated partial thromboplastin time (aPTT)-based one-stage clotting assay reagents with normal human plasma calibrators. To date, there are few data on the measurement accuracy of samples from patients treated with N8-GP. Here, we measure patient samples during routine treatment monitoring. Three previously treated patients with severe hemophilia A (HA) without inhibitors (baseline FVIII activity <0.01 IU/mL) received 50 IU/kg N8-GP every fourth day or twice weekly over 5 years as part of the pathfinder2 trial. Patient samples were monitored using the Pathromtin® SL aPTT reagent (Siemens Healthcare GmbH, Erlangen, Germany), a BCS® XP System analyzer (Siemens), and Standard Human Plasma (Siemens) or product-specific calibrators. Patient age ranged from 36 to 62 years. Overall, measurements performed using product-specific or Standard Human Plasma calibrators were in good agreement, with ratios randomly distributed around 1.0. Peak ratios tended to be closer to 1.0 than trough samples. Pathromtin® SL with Standard Human Plasma calibrator consistently and accurately measured FVIII activity in samples from severe HA patients receiving N8-GP prophylaxis.
      (© 2019 S. Karger AG, Basel.)
    • Contributed Indexing:
      Keywords: Analysis; Clinical laboratory techniques; Factor VIII; Hemophilia A; Partial thromboplastin time
    • Accession Number:
      0 (recombinant factor VIII N8)
      9001-27-8 (Factor VIII)
    • Publication Date:
      Date Created: 20191023 Date Completed: 20201028 Latest Revision: 20201028
    • Publication Date:
      20250114
    • Accession Number:
      10.1159/000503377
    • Accession Number:
      31639805