Emicizumab Calibrator is a calibrator plasma intended for use in the calibration of a modified one-stage FVIII activity assay for determination of active emicizumab concentration from a clot time measurement performed on an automated coagulation analyzer.
Emicizumab Calibrator may be used together with a modified one-stage FVIII assay to generate a calibration curve for emicizumab determination using citrated plasma from patients with hemophilia A being treated with the drug.
The principle of the modified one-stage FVIII assay for emicizumab measurement relies upon measuring the degree of correction of the APTT when patient plasma is added to FVIII deficient plasma. The degree of correction is related to the amount of emicizumab in the patient’s sample. Quantification of the degree of correction is enabled by using a calibration curve constructed using the Emicizumab Calibrator.