Emicizumab Controls Level 1 and Level 2 are assayed controls intended for quality control of a modified one-stage FVIII activity assay for determination of active emicizumab concentration from a clot time measurement performed on an automated coagulation analyze.
Emicizumab Controls may be used together with the Emicizumab Calibrator and a modified one-stage FVIII assay as QC material for use in a laboratory’s quality control program.
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. Control of the accuracy of the emicizumab result is enabled by using Emicizumab Controls with assayed emicizumab values.