A universal anti-Xa assay for rivaroxaban, apixaban, and edoxaban measurements: method validation, diagnostic accuracy and external validation.

Details

Serval ID
serval:BIB_8C48E3940F7E
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
A universal anti-Xa assay for rivaroxaban, apixaban, and edoxaban measurements: method validation, diagnostic accuracy and external validation.
Journal
British journal of haematology
Author(s)
Willekens G., Studt J.D., Mendez A., Alberio L., Fontana P., Wuillemin W.A., Schmidt A., Graf L., Gerber B., Bovet C., Sauter T.C., Nagler M.
ISSN
1365-2141 (Electronic)
ISSN-L
0007-1048
Publication state
Published
Issued date
06/2021
Peer-reviewed
Oui
Volume
193
Number
6
Pages
1203-1212
Language
english
Notes
Publication types: Clinical Trial ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't ; Validation Study
Publication Status: ppublish
Abstract
A universal anti-Xa assay for the determination of rivaroxaban, apixaban and edoxaban drug concentrations would simplify laboratory procedures and facilitate widespread implementation. Following two pilot studies analysing spiked samples and material from 698 patients, we conducted a prospective multicentre cross-sectional study, including 867 patients treated with rivaroxaban, apixaban or edoxaban in clinical practice to comprehensively evaluate a simple, readily available anti-Xa assay that would accurately measure drug concentrations and correctly predict relevant levels in clinical practice. Anti-Xa activity was measured by an assay calibrated with low-molecular-weight heparin (LMWH) in addition to ultra-high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). As an external validation, LMWH-calibrated anti-Xa activity was also determined in nine external laboratories. The LMWH-calibrated anti-Xa activity correlated strongly with rivaroxaban, apixaban or edoxaban drug levels [r <sub>s</sub> = 0·98, 95% confidence interval (CI) 0·98-0·98]. The sensitivity for the clinically relevant cut-off levels of 30, 50 and 100 µg/l was 96·2% (95% CI 94·4-97·4), 96·4% (95% CI 94·4-97·7) and 96·7% (95% CI 94·3-98·1) respectively. Concordant results were obtained in the external validation study. In conclusion, a universal, LMWH-calibrated anti-Xa assay accurately measured rivaroxaban, apixaban and edoxaban concentrations and correctly predicted relevant drug concentrations in clinical practice.
Keywords
Adolescent, Adult, Aged, Aged, 80 and over, Chromatography, High Pressure Liquid, Cross-Sectional Studies, Cyclophosphamide/pharmacokinetics, Drug Monitoring, Factor Xa Inhibitors/blood, Female, Humans, Male, Middle Aged, Pilot Projects, Pyrazoles/pharmacokinetics, Pyridones/pharmacokinetics, Retrospective Studies, Rivaroxaban/pharmacokinetics, Tandem Mass Spectrometry, apixaban, drug monitoring, edoxaban, factor Xa inhibitors, heparin, low-molecular-weight, rivaroxaban
Pubmed
Web of science
Open Access
Yes
Create date
24/05/2021 13:20
Last modification date
21/10/2021 5:40
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