Monitoring of different factor VIII replacement products using a factor VIII one-stage clotting assay on cobas t 511/711 analysers.

ABSTRACT:

Introduction

Recombinant coagulation factor VIII (FVIII) products are the standard of care for patients with haemophilia A. The development of modified FVIII products has provided benefit for patients but presented challenges for monitoring FVIII activity.

Aim

This single-centre study evaluated the Roche FVIII one-stage clotting assay (OSA) in measuring FVIII activity in plasma samples spiked with seven FVIII products at clinically relevant concentrations.

Methods

FVIII-deficient plasma samples were spiked with two batches of recombinant FVIII products (octocog alfa, moroctocog alfa, simoctocog alfa, efmoroctocog alfa, damoctocog alfa pegol, rurioctocog alfa pegol, lonoctocog alfa) at 1-120 IU/dL FVIII activity, according to their labelled potency. Measurement was con

SUBMITTER: Ketteler C 

PROVIDER: S-EPMC9291471 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature