Table 2.
Minor increase in spike recovery for rFVIIIFc compared with Advate® by the chromogenic substrate assay
| Label activity, IU mL−1 | Mean recovery, % of label (n = 10 or 11 per level) | Mean intra-laboratory % CV (n = 3 per laboratory) | Inter-laboratory % CV (n = 11) | |
|---|---|---|---|---|
| Advate® | 0.80 | 108.1 | 4.4 | 18 |
| 0.20 | 112.4 | 11.7 | 26 | |
| 0.05 | 101.8 | 12.5 | 38 | |
| rFVIIIFc | 0.87 | 119.0 | 2.9 | 19 |
| 0.22 | 133.4 | 7.0 | 23 | |
| 0.054 | 120.2 | 8.3 | 31 |
Conducted in 11 laboratories.
CV, coefficient of variance; rFVIIIFc, recombinant factor VIII Fc fusion protein.