| Autor: |
Lefebvre CS; Service d'Hématologie Biologique, Assistance Publique Hôpitaux de Paris-Centre (AP-HP.CUP), F-75015 Paris, France., Luneau S; Service d'Hématologie Biologique, Assistance Publique Hôpitaux de Paris-Centre (AP-HP.CUP), F-75015 Paris, France., Bentounes NK; Service d'Hématologie Biologique, Assistance Publique Hôpitaux de Paris-Centre (AP-HP.CUP), F-75015 Paris, France., Mauge L; Service d'Hématologie Biologique, Assistance Publique Hôpitaux de Paris-Centre (AP-HP.CUP), F-75015 Paris, France, Université Paris Cité, Inserm, PARCC, F 75015 Paris, France., Dumont A; Service d'Hématologie Biologique, Assistance Publique Hôpitaux de Paris-Centre (AP-HP.CUP), F-75015 Paris, France., Gaussem P; Service d'Hématologie Biologique, Assistance Publique Hôpitaux de Paris-Centre (AP-HP.CUP), F-75015 Paris, France, Université Paris Cité, Innovative Therapies in Haemostasis, INSERM, 75006 Paris, France., Helley D; Service d'Hématologie Biologique, Assistance Publique Hôpitaux de Paris-Centre (AP-HP.CUP), F-75015 Paris, France, Université Paris Cité, Inserm, PARCC, F 75015 Paris, France., Smadja DM; Service d'Hématologie Biologique, Assistance Publique Hôpitaux de Paris-Centre (AP-HP.CUP), F-75015 Paris, France, Université Paris Cité, Innovative Therapies in Haemostasis, INSERM, 75006 Paris, France, INNOVTE, F-CRIN, Saint-Étienne, France., Gendron N; Service d'Hématologie Biologique, Assistance Publique Hôpitaux de Paris-Centre (AP-HP.CUP), F-75015 Paris, France, Université Paris Cité, Innovative Therapies in Haemostasis, INSERM, 75006 Paris, France, INNOVTE, F-CRIN, Saint-Étienne, France. |
| Abstrakt: |
Edoxaban is a direct oral anticoagulant available in Europe but not in France. Given the high tourist traffic in France, understanding the pharmacology of edoxaban and the availability of its laboratory testing seemed crucial in emergency situations. The aim of this work was to describe the methodology for measuring the anti-Xa activity of edoxaban, highlighting pre-analytical and analytical aspects, along with essential clinico-biological data for therapeutic guidance. The analysis was performed using the chromogenic method on the STAR-Max analyzer, with the STA®-Liquid ANTI-Xa kit (Diagnostica Stago®). Anti-Xa Edoxaban level measurement has a detection limit of 15 ng/mL, a quantification limit of 20 ng/mL and a linearity limit of 400 ng/mL. Repeatability, intermediate precision, accuracy, and measurement uncertainty studies were conducted to assess method performance, meeting quality requirements. The comparison between two STAR-Max® analyzers showed excellent results with linear regression and a low bias with good precision and no loss of dispersion regardless of edoxaban levels. In conclusion, although the measurement of edoxaban level may be rarely necessary in clinical practice, its implementation is straightforward. The availability of edoxaban in neighboring countries, underscores the importance of having its measurement available in hospital laboratories. |
