Emicizumab, a drug intended for the prophylactic treatment of patients with hemophilia A, is a bispecific antibody that bridges activated Factor IX (FIXa) and Factor X (FX), there by restoring FVIII function, necessary for normal hemostasis.
The Emicizumab Calibrator can be used to determine the active amount of Emicizumab by measuring FVIII activity in a one-step chronometric assay with a hemostasis analyzer in citrated human plasma.
The calibrator is used to determine the amount of active Emicizumab in the plasma based on the measurement of the activated partial thromboplastin time.
After dilution of the calibrator, plasma deficient in FVIII is added as well as TCA reagent.
Coagulation is initiated by adding CaCl2.
The degree of TCA correction is correlated with the activity of Emicizumab, the concentration of which in µg / mL is determined using a calibration curve.
- 5 vials of 1 mL, lyophilized (citrated plasma immunodepleted in FVIII with 100µg / mL Emicizumab)