Burger, Annika; Studt, Jan-Dirk; Mendez, Adriana; Alberio, Lorenzo; Fontana, Pierre; Wuillemin, Walter A; Schmidt, Adrian; Graf, Lukas; Gerber, Bernhard; Bovet, Cédric; Sauter, Thomas C; Binder, Nikolaus B; Nagler, Michael (2023). Determination of Anti-Xa Inhibitor Plasma Concentrations Using a Universal Edoxaban Calibrator. Diagnostics, 13(12) MDPI 10.3390/diagnostics13122128
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A universal calibrator for the determination of all anti-Xa inhibitors would support laboratory processes. We aimed to test the clinical performance of an anti-Xa assay utilizing a universal edoxaban calibrator to determine clinically relevant concentrations of all anti-Xa inhibitors. Following a pilot study, we enrolled 553 consecutive patients taking rivaroxaban, edoxaban, or apixaban from nine study centers in a prospective cross-sectional study. The Technochrom® anti-Xa assay was conducted using the Technoview® edoxaban calibrator. Using ultra-high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS), anti-Xa inhibitor drug concentrations were determined. Sensitivities and specificities to detect three clinically relevant drug concentrations (30 µgL-1, 50 µgL-1, 100 µgL-1) were determined. Overall, 300 patients treated with rivaroxaban, 221 with apixaban, and 32 with edoxaban were included. The overall correlation coefficient (rs) was 0.95 (95% CI 0.94, 0.96). An area under the receiver operating characteristic curve of 0.96 for 30 µgL-1, 0.98 for 50 µgL-1, and 0.99 for 100 µgL-1 was found. The sensitivities were 92.3% (95% CI 89.2, 94.6), 92.7% (89.4, 95.1), and 94.8% (91.1, 97.0), respectively (specificities 82.2%, 93.7%, and 94.4%). In conclusion, the clinical performance of a universal, edoxaban-calibrated anti-Xa assay was solid and most drug concentrations were predicted correctly.
Item Type: |
Journal Article (Original Article) |
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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 |
UniBE Contributor: |
Bovet, Cédric, Sauter, Thomas Christian, Nagler, Michael |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
2075-4418 |
Publisher: |
MDPI |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
28 Jun 2023 15:52 |
Last Modified: |
28 Jun 2023 16:01 |
Publisher DOI: |
10.3390/diagnostics13122128 |
PubMed ID: |
37371023 |
Uncontrolled Keywords: |
anti-Xa assay anticoagulants introduction apixaban diagnostic accuracy edoxaban laboratory monitoring rivaroxaban |
BORIS DOI: |
10.48350/184212 |
URI: |
https://boris.unibe.ch/id/eprint/184212 |
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