Measuring rFIX-Fc with 17 Different Combinations Coagulometers — Reagents: A Single Center Study

Autor: Adeline Trayaud, Maryse Tardieu, Aurélien Lebreton, Laurie Talon, Thomas Sinegre, Aurélie Vaissade
Rok vydání: 2018
Předmět:
Zdroj: Blood. 132:5016-5016
ISSN: 1528-0020
0006-4971
Popis: rFIX-Fc is an extended half-life (EHL) recombinant FIX concentrate approved for the prophylaxis and treatment of bleeding events in haemophilia B. A high laboratory and reagent-specific variability is described for rFIX-Fc activity measurements, overall in lower FIX concentrations. The aim of this single-center study was to evaluate the intra-laboratory variability of 17 different combinations coagulometers/reagents including both one stage clotting (OSC) and chromogenic assays with a focus on lower concentrations. Human FIX deficient plasma (FIX The summary of all spikes recoveries' are presented in table 1. We confirmed that kaolin based OSC assays underestimate rFIX-Fc including for low concentrations. Acceptable recoveries were found for PTT automate on Stago coagulometer from 150% to 5% and an underestimation was found for low concentrations (2% and 1 %). Pathromtin and Actin FS performed on Cs2100 display acceptable recoveries on all the range of target values. Synthasil performed on ACL TOP700 have acceptable recoveries from 150% to 20% and an overestimation was found for low concentrations (5% to 1%). STA-Cephascreen performed on the 3 coagulometers has acceptable recoveries, except for low concentrations (5% to 1%) on ACL TOP coagulometer, leading to an overestimation of rFIX-FC measurements. Synthafax performed on the 3 coagulometers has acceptable recoveries with ACL TOP700 coagulometer for all the range of concentrations. This reagent adapted on STAR MAX coagulometer shows an overall overestimation of rFIX-Fc measurements (except for the 150% target concentration) and when adapted on a Cs2100 coagulometer, it displays acceptable recoveries except for low concentrations (5% to 1%) that are overestimated. The two chromogenic assays have acceptable recoveries for rFIX-Fc on all coagulometers from 150% to 50% concentrations. ROS FIXa underestimated rFIX-Fc recovery for the lower concentrations (1% and 2%) on STAR MAX and ACL TOP700 coagulometers. Biophen FIX:C underestimated rFIX-Fc recoveries for concentrations below 50% with all coagulometers. This study provides the pattern of several combinations coagulometers - reagents for rFIX-Fc measurements and confirms a high variability for several reagents for low concentrations. Table. Table. Disclosures Lebreton: Sobi: Consultancy, Research Funding.
Databáze: OpenAIRE
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