Table 2.
Geometric mean (GM) and intra‐assay variability expressed as geometric coefficient of variation (%GCV) for all reagents/kits when testing plasma‐derived FIX (PD), recombinant FIX (RB) and dalcinonacog alfa (DA) against the plasma‐derived concentrate international standard: S1, using different one‐stage clotting assays (OSCA) reagents and chromogenic assay (ChA) kits. No %GCV is given for APTT‐SP as only 1 valid assay was obtained using this reagent
| PD | RB | DA | ||||
|---|---|---|---|---|---|---|
| GM IU/mL | GCV (%) | GM IU/mL | GCV (%) | GM IU/mL | GCV (%) | |
| OSCA reagents | ||||||
| APTT‐SP | 9.7 | 3.9 | 9.2 | 2.9 | 8.2 | ‐ |
| SynthasIL | 9.7 | 5.7 | 9.4 | 13.6 | 8.9 | 6.8 |
| SynthaFax | 9.7 | 3.7 | 6.6 | 8.2 | 5.2 | 13.3 |
| CK Prest | 9.6 | 4.2 | 9.4 | 5.7 | 14.1 | 4.5 |
| Cephascreen | 9.5 | 6.6 | 10.6 | 6.2 | 11.1 | 3.0 |
| Dapttin | 9.9 | 8.4 | 9.7 | 6.8 | 13.8 | 10.5 |
| Siron | 10.3 | 4.8 | 10.1 | 9.9 | 9.4 | 8.7 |
| Actin‐FS | 10.1 | 5.9 | 9.7 | 4.1 | 7.6 | 4.5 |
| Pathromtin SL | 10.3 | 7.3 | 8.4 | 13.8 | 7.1 | 9.5 |
| ChA kits | ||||||
| Rossix | 10.3 | 2.1 | 7.6 | 4.0 | ‐ | ‐ |
| Hyphen | 9.5 | 4.0 | 6.6 | 6.9 | ‐ | ‐ |