Monitoring of different factor VIII replacement products using a factor VIII one‐stage clotting assay on cobas t 511/711 analysers
| Autor: | Carolin Ketteler, Nina Richter, Ingrid Hoffmann, Andreas Tiede, Simon Davidson |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
congenital
hereditary and neonatal diseases and abnormalities animal diseases Haemophilia A Pharmacology Hemophilia A Haemophilia Hemostatics law.invention LONOCTOCOG ALFA stomatognathic system law hemic and lymphatic diseases medicine Moroctocog alfa Humans Potency Genetics (clinical) Factor VIII business.industry One stage Hematology General Medicine medicine.disease Coagulation Recombinant DNA Blood Coagulation Tests business |
| Zdroj: | Haemophilia. 27 |
| ISSN: | 1365-2516 1351-8216 |
| DOI: | 10.1111/hae.14416 |
| Popis: | INTRODUCTION Recombinant coagulation factor VIII (FVIII) products are the standard of care for patients with haemophilia A. The development of modified FVIII products has provided benefit for patients but presented challenges for monitoring FVIII activity. AIM This single-centre study evaluated the Roche FVIII one-stage clotting assay (OSA) in measuring FVIII activity in plasma samples spiked with seven FVIII products at clinically relevant concentrations. METHODS FVIII-deficient plasma samples were spiked with two batches of recombinant FVIII products (octocog alfa, moroctocog alfa, simoctocog alfa, efmoroctocog alfa, damoctocog alfa pegol, rurioctocog alfa pegol, lonoctocog alfa) at 1-120 IU/dL FVIII activity, according to their labelled potency. Measurement was conducted on the cobas t 511/711 analysers using the Roche FVIII OSA and the Technoclone TECHNOCHROM FVIII:C chromogenic substrate assay (CSA). RESULTS Using the OSA, FVIII activity was close to labelled potency for most analysed FVIII products including a recombinant FVIII Fc fusion protein. PEGylated FVIII product, damoctocog alfa pegol, was marginally above and single-chain product, lonoctocog alfa, below the predefined acceptance criteria: for FVIII activity |
| Databáze: | OpenAIRE |
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