Measurements of eftrenonacog alfa by 19 different combinations reagents/instrument: A single-centre study.
Fc fusion
chromogenic assay
clotting assay
eftrenonacog alfa
factor IX
haemophilia
Journal
Haemophilia : the official journal of the World Federation of Hemophilia
ISSN: 1365-2516
Titre abrégé: Haemophilia
Pays: England
ID NLM: 9442916
Informations de publication
Date de publication:
May 2020
May 2020
Historique:
received:
31
01
2020
revised:
19
03
2020
accepted:
30
03
2020
pubmed:
22
4
2020
medline:
15
12
2020
entrez:
22
4
2020
Statut:
ppublish
Résumé
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. To compare rFIXFc measurements obtained using different instruments and common OSC and chromogenic asssays. 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. 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. 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.
Substances chimiques
Immunoglobulin Fc Fragments
0
Indicators and Reagents
0
Recombinant Fusion Proteins
0
factor IX Fc fusion protein
0
Factor IX
9001-28-9
Types de publication
Case Reports
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
543-552Subventions
Organisme : Sobi
Informations de copyright
© 2020 John Wiley & Sons Ltd.
Références
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