Table 3.
Overall geometric mean (GM) and method GM (one‐stage clotting assays (OSCA) and chromogenic assays (ChA)) as well as inter‐assay variability (% geometric coefficient of variation (GCV) or range where only 2 kits tested) for plasma‐derived FIX (PD), recombinant FIX (RB) and dalcinonacog alfa (DA) against the plasma‐derived concentrate international standard: S1 and the plasma international standard: S2
| PD | RB | DA | |||||
|---|---|---|---|---|---|---|---|
| GM IU/mL | GCV/range | GM IU/mL | GCV/range | GM IU/mL | GCV/range | ||
| vs S1 | |||||||
| OSCA | 9.88 | 2.9% | 9.16 | 14.9% | 9.08 | 37.6% | |
| ChA | 9.92 | 9.5‐10.3 IU/mL | 7.10 | 6.6‐7.6 IU/mL | ‐ | ‐ | |
| Overall | 9.89 | 3.4% | 8.74 | 17.9% | 9.08 | 37.6% | |
| vs S2 | |||||||
| OSCA | 10.77 | 5.8% | 10.12 | 16.2% | 10.29 | 45.6% | |
| ChA | 10.84 | 10.4‐11.4 IU/mL | 7.77 | 7.7‐7.9 IU/mL | ‐ | ‐ | |
| Overall | 10.78 | 5.7% | 9.65 | 18.7% | 10.29 | 45.6% | |