TABLE 4. Example of factor VIII (FVIII) inhibitor measurement on a haemophilia A patient specimen containing Hemlibra® (emicizumab, ACE910) using the Nijmegen-Bethesda assay and the chromogenic Bethesda assay.
Predilution | Patient Mix U/dL FVIIIa |
Control Mix U/dL FVIIIa |
% Residual Activityb |
Calculated Unitsc | Total Unitsd | |
---|---|---|---|---|---|---|
Nijmegen-Bethesda Assay |
Undiluted | 116 | 37 | 313.5 | 0 NBU | IS |
Chromogenic Bethesda Assay |
Undiluted | 23 | 37 | 62.2 | 0.69 CBU | 0.7 CBU |
IS, interfering substance.
Units per decilitre of FVIII activity.
Patient mix units per decilitre FVIII activity/control mix units per decilitre FVIII activity × 100.
Nijmegen-Bethesda units (NBU) or chromogenic Bethesda units (CBU) calculated as NBU or CBU = (2-log %residual activity) (0.301)−1.
Calculated NBU × predilution factor.