FVIII activity in samples taken at various time points from 21 patients treated with N8-GP (Esperoct® ; turoctocog alfa pegol) during the pathfinder clinical trial programme was assessed and compared using different assay methods. FVIII activity measurements in samples from patients treated with N8-GP were similar using chromogenic assays, regardless of calibration method or kit/analyser combination. FVIII activity measurements using one-stage aPTT-based assays were slightly lower when calibrated using normal human plasma (NHP) compared with a product-specific standard; this difference may be partially attributable to differences in the aPTT reagent/analyser combinations used to perform the measurements. Overall, these results confirm the accuracy of FVIII activity measurements using N8-GP-treated patient samples and routine clinical laboratory methods with NHP calibration.
© 2020 John Wiley & Sons Ltd.