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

Willekens, Guido; Studt, Jan-Dirk; Mendez, Adriana; Alberio, Lorenzo; Fontana, Pierre; Wuillemin, Walter A; Schmidt, Adrian; Graf, Lukas; Gerber, Bernhard; Bovet, Cedric; Sauter, Thomas C; Nagler, Michael (2021). A universal anti-Xa assay for rivaroxaban, apixaban, and edoxaban measurements: method validation, diagnostic accuracy and external validation. British journal of haematology, 193(6), pp. 1203-1212. Wiley-Blackwell 10.1111/bjh.17470

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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 [rs  = 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Institute of Clinical Chemistry
04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > University Emergency Center
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Haematology and Central Haematological Laboratory

UniBE Contributor:

Sauter, Thomas Christian and Nagler, Michael

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0007-1048

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Pierrette Durand Lüthi

Date Deposited:

28 Jun 2021 15:41

Last Modified:

28 Jun 2021 15:41

Publisher DOI:

10.1111/bjh.17470

PubMed ID:

33954979

Uncontrolled Keywords:

apixaban drug monitoring edoxaban factor Xa inhibitors heparin low-molecular-weight rivaroxaban

BORIS DOI:

10.48350/156860

URI:

https://boris.unibe.ch/id/eprint/156860

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