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Measuring Emicizumab Levels in the Hemostasis Laboratory
Geoffrey Kershaw1, Caroline Dix2
1Institute of Haematology, Royal Prince Alfred Hospital, Sydney, Australia. Geoffrey.Kershaw@health.nsw.gov.au.
Methods in Molecular Biology (Clifton, N.J.)
|May 19, 2023
Summary
Emicizumab prophylaxis prevents bleeds in hemophilia A, even with inhibitors. A one-stage clotting assay can measure emicizumab levels when unexpected bleeding occurs.
Area of Science:
- Hematology
- Pharmacology
- Clinical Chemistry
Background:
- Emicizumab is a novel prophylactic agent for hemophilia A (HA).
- It is effective in patients with and without Factor VIII (FVIII) inhibitors.
- Typically administered in fixed weight-based doses, it usually does not require laboratory monitoring.
Purpose of the Study:
- To describe the performance of a one-stage clotting assay for measuring emicizumab.
- To provide guidance on laboratory monitoring in specific clinical scenarios.
Main Methods:
- Detailed description of a one-stage clotting assay.
- Validation of the assay for emicizumab quantification.
Main Results:
- The one-stage clotting assay accurately quantifies emicizumab levels.
- Assay performance characteristics are suitable for clinical use.
Conclusions:
- Laboratory monitoring of emicizumab is feasible with a one-stage clotting assay.
- This assay is valuable in managing HA patients experiencing unexpected bleeding events despite prophylaxis.

