Figure 2.

Individual laboratory one‐stage clotting assay results for recombinant FIX–albumin fusion protein (rIX‐FP). (A) Use of locally prepared spiked plasma samples from lyophilized rIX‐FP by further dilution at rIX‐FP‐spiked concentrations of 0.9, 0.5 and 0.25 IU mL ⁻¹. (B) Use of centrally prepared spiked plasma samples at rIX‐FP‐spiked concentrations of 0.625, 0.25 and 0.1 IU mL ⁻¹. Target spikes are shown by dashed lines, and ± 30% thresholds by dotted lines.