A field study evaluating the activity of N8-GP in spiked plasma samples at clinical haemostasis laboratories.

ABSTRACT:

Aim

N8-GP (turoctocog alfa pegol) is a glycoPEGylated, extended half-life human recombinant factor VIII (FVIII) shown to be an efficacious treatment for patients with haemophilia A. Accurate monitoring of replacement therapy helps ensure proper dosing, leading to better patient care. The objective of this field study was to evaluate the accuracy and intra- and inter-laboratory variabilities of N8-GP and rAHF (Advate^® ) FVIII activity (FVIII:C) measurements in clinical laboratories using their routine methods and reagents.

Methods

Laboratories measured plasma samples spiked with 0.03, 0.2, 0.6 and 0.9 IU/mL N8-GP or rAHF. Samples were blinded, and laboratories were instructed to perform evaluations using their routine FVIII activity assays and calibrators.

Resul

SUBMITTER: Tiefenbacher S 

PROVIDER: S-EPMC6852407 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature