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Evaluation of N8-GP activity using a one-stage clotting assay: a single-center experience

By Inga Hegemann, Karin Koch, Wan Hui Ong Clausen, Mirella Ezban and Brigitte Brand-Staufer


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

Topics: Clinic for Oncology and Hematology, 610 Medicine & health
Publisher: Karger
Year: 2019
DOI identifier: 10.1159/000503377
OAI identifier:
Provided by: ZORA
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