Thrombin generation assay using factor XIa to measure factors VIII and IX and their glycoPEGylated derivatives is robust and sensitive.

摘要: SummaryBackground Conventional coagulation factor assays are associated with certain limitations, as they do not always reflect the clinical heterogeneity of bleeding in hemophilic patients or correctly individual patient response to treatment bypassing agents novel concentrates. The thrombin generation assay (TGA) is currently being assessed a possible method for characterizing phenotypes individuals hemophilia. Objectives This study robustness and sensitivity TGA measuring activity recombinant VIII (rFVIII), IX (rFIX) their glycoPEGylated derivatives, N8-GP N9-GP, vitro. Methods Factor-deficient plasma was spiked 0.13–130 IU dL−1 rFVIII (hemophilia A [HA] plasma), rFIX N9-GP B [HB] plasma). calibrated automated thrombogram triggered tissue (TF) activated FXI (FXIa) used measure over time. Endogenous potential, peak thrombin, velocity index, lag time were analyzed. Results FXIa-triggered affected by glycoPEGylation sufficiently sensitive differentiate between samples mimicking severe moderate HB HA; TF-triggered this distinction HA. Both FXIa-triggered had an acceptable level variability (≤ 20%), although greater variability. Conclusions FXIa-triggered reactions produced more robust results than reactions, have potential use monitoring treated non-PEGylated These promising merit confirmation correlate vitro vivo data.