Mise en place du dosage de l’activité anti-Xa de l’edoxaban dans un laboratoire hospitalier et évaluation de ses performances analytiques (notice n° 276815)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04620cam a2200505 4500500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250117194050.0 |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | fre |
| 042 ## - AUTHENTICATION CODE | |
| Authentication code | dc |
| 100 10 - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Lefebvre, Corentin S. |
| Relator term | author |
| 245 00 - TITLE STATEMENT | |
| Title | Mise en place du dosage de l’activité anti-Xa de l’edoxaban dans un laboratoire hospitalier et évaluation de ses performances analytiques |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Date of publication, distribution, etc. | 2024.<br/> |
| 500 ## - GENERAL NOTE | |
| General note | 90 |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | 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. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | L’edoxaban est un anticoagulant oral direct disponible en Europe mais indisponible en France. Face à la forte affluence touristique en France, la connaissance de la pharmacologie de l’edoxaban et la disponibilité de son dosage en laboratoire nous ont semblé cruciales en cas de situations d’urgence.L’objectif de ce travail était de décrire la méthodologie du dosage de l’activité anti-Xa de l’edoxaban, en mettant en avant les aspects pré-analytiques et analytiques ainsi que les données clinico-biologiques essentielles au conseil thérapeutique.Le dosage de l’activité anti-Xa de l’edoxaban a été réalisé selon une méthode chromogénique sur l’analyseur STAR-Max avec le coffret STA®-Liquid ANTI-Xa (Diagnostica Stago®). Les résultats du dosage de l’edoxaban présentaient une limite de détection à 15 ng/mL, une limite de quantification à 20 ng/mL et une limite supérieure de linéarité à 400 ng/mL. Des études de répétabilité, de fidélité intermédiaire, d’exactitude et d’incertitude de mesure ont été effectuées afin d’évaluer les performances de la méthode et la conformité aux exigences de qualité. La comparaison entre deux automates STAR-Max® a montré d’excellents résultats en régression linéaire et un faible biais avec une bonne précision et sans perte de dispersion quelle que soit la concentration de l’edoxaban.En conclusion, bien que le dosage de l’edoxaban puisse être rarement nécessaire en pratique, sa mise en place est simple. La disponibilité de l’edoxaban dans les pays voisins souligne l’importance de disposer de son dosage en laboratoires d’hémostase hospitalier. |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | hémostase |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | edoxaban |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | accréditation |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | anti-Xa |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | anticoagulant oral direct |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | hémostase |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | edoxaban |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | accréditation |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | anti-Xa |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | anticoagulant oral direct |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | accreditation |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | edoxaban |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | anti-Xa |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | direct oral anticoagulant |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | hemostasis |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | accreditation |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | edoxaban |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | anti-Xa |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | direct oral anticoagulant |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | hemostasis |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Luneau, Sophie |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Bentounes, Nûn Kalim |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Mauge, Laetitia |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Dumont, Aurélie |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Gaussem, Pascale |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Helley, Dominique |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Smadja, David M. |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Gendron, Nicolas |
| Relator term | author |
| 786 0# - DATA SOURCE ENTRY | |
| Note | Annales de Biologie Clinique | 82 | 4 | 2024-10-09 | p. 451-460 | 0003-3898 |
| 856 41 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://shs.cairn.info/revue-annales-de-biologie-clinique-2024-4-page-451?lang=fr&redirect-ssocas=7080">https://shs.cairn.info/revue-annales-de-biologie-clinique-2024-4-page-451?lang=fr&redirect-ssocas=7080</a> |
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