Measurements of eftrenonacog alfa by 19 different combinations reagents/instrument: A single-centre study
| Autor: | Marc G. Berger, Maxence Tillier, Aurélie Vaissade, Anne‐Lise Barbin, Thomas Sinegre, Maryse Tardieu, Laurie Talon, Stéphanie Senectaire, Virginie Fourneyron, Aurélien Lebreton, Piotr Gembara, Adeline Trayaud |
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| Přispěvatelé: | Unité de Nutrition Humaine (UNH), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias (CHELTER), Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), CHU Clermont-Ferrand, Registre des Cancers de l'Enfant d'Auvergne-Limousin, Sobi |
| Rok vydání: | 2020 |
| Předmět: |
Male
Adolescent Fc fusion Recombinant Fusion Proteins haemophilia 030204 cardiovascular system & hematology Factor IX 03 medical and health sciences 0302 clinical medicine chromogenic assay External quality assessment eftrenonacog alfa medicine Eftrenonacog alfa Humans Haemophilia B Genetics (clinical) Chromatography business.industry Chromogenic [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology Hematology General Medicine medicine.disease 3. Good health Immunoglobulin Fc Fragments Single centre Reagent clotting assay Female Indicators and Reagents business 030215 immunology medicine.drug |
| Zdroj: | Haemophilia Haemophilia, Wiley, 2020, 26 (3), pp.543-552. ⟨10.1111/hae.14003⟩ |
| ISSN: | 1365-2516 1351-8216 |
| Popis: | International audience; Introduction Recombinant factor IX Fc fusion protein (rFIXFc) is an extended half-life concentrate for the treatment of haemophilia B (HB). rFIXFc activity monitoring is crucial in several clinical situations. However, differences were observed between one-stage clotting (OSC) and chromogenic assays, but not for all factor IX (FIX) concentrations.Aims To compare rFIXFc measurements obtained using different instruments and common OSC and chromogenic asssays.Methods FIX:C measurements were performed in rFIXFc-spiked plasma aliquots (targeted FIX levels of 1.5, 1, 0.5, 0.2, 0.05, 0.02 and 0.01 IU/mL) and plasma samples collected from two patients with HB at various time points after rFIXFc infusion, using three instruments (STA-R MAX, ACLTOP700 and CS2100i) and common clotting and chromogenic FIX:C assays.Results The same reagent could give different FIX:C measurements when adapted to different instruments. Moreover, the same reagent/instrument combination could give different results depending of the FIX concentration. For OSC assays, only STA-Cephascreen on STA-R MAX and CS2100i, SynthAFax on ACLTOP 700 and Actin on CS2100i provided acceptable recoveries for all rFIXFc concentrations. The chromogenic assays ROX-FIX and Biophen FIX:C underestimated rFIXFc for concentrations lower than 0.05 and 0.2 IU/mL, respectively.Conclusions Our study demonstrates that the same reagent adapted to different instruments could lead to different rFIXFc values. As rFIXFc under/overestimation could be associated with inappropriate treatment or biased calculation of pharmacokinetic parameters, the reagent/instrument combination used by haemostasis laboratories should be considered and regularly evaluated by external quality assessment programmes. |
| Databáze: | OpenAIRE |
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