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Emicizumab Calibrator
Size: 5 x 1 mL
Plasma Calibrator (100 ug/mL Emicizumab)
Emicizumab Calibrator is a calibrator intended for use in the calibration of a modified one-stage FVIII activity assay for the 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 haemophilia A being treated with the drug.
Principle of the Test
The principle of the one-stage FVIII assay for emicizumab measurement relies upon measuring the degree of correction of the APTT when a patient plasma is added to FVIII deficient plasma. The degree of correction is related to the amount of emicizumab in the patient's sample. Quatification of the degree of correction is enabled by using a calibration curve constructed using the Emicizumab Calibrator
Reporting Units
100 ug/mL
References
1. Shinohara S, Saito T, Noguchi-Sasaki M, Ishiwata T, Morris M: Evaluation of Emicizumab Calibrator and Controls with a Modified One-stage FVIII Assay on an Automated Coagulation Analyzer. ISTH 2019 Melbourne, Abstract PB1305
2. Ramamurthy N, Kucharski C, McInerney M, Chen D, Morris M: Analytical Performance Evaluation of a Dedicated Calibrator and Controls for Emicizumab Quantification. ISTH 2019 Melbourne, Abstract OC 07.4.
3. Müller J, Pekrul I, Pötzsch B, Berning B, Oldenburg J, Spannagl M: Laboratory Monitoring in Emicizumab-Treated Persons with Hemophilia A. Thromb Haemost 2019; 119(09): 1384-1393.
4. Clinical Commissioning Policy: Emicizumab as prophylaxis in people with severe congenital haemophilia A without factor VIII inhibitors (all ages). First published: August 2019 Prepared by NHS England Specialised Services Clinical Reference Group for Specialised Blood Disorders Published by NHS England, in electronic format only.
Product Insert (151-201-CE EMICIZUMAB CALIBRATOR) Method Application (EMICIZUMAB SIEMENS) Material Data Safety Sheet (151-201-CE EMICIZUMAB CALIBRATOR) Method Application (EMICIZUMAB GENERAL)