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20 juin 2023
- doi: 10.3390/diagnostics13122128
- issn: 2075-4418
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info:eu-repo/semantics/altIdentifier/doi/10.3390/diagnostics13122128
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info:eu-repo/semantics/altIdentifier/pmid/37371023
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info:eu-repo/semantics/altIdentifier/urn/urn:nbn:ch:serval-BIB_069DE54969CE2
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A. Burger et al., « Determination of Anti-Xa Inhibitor Plasma Concentrations Using a Universal Edoxaban Calibrator. », Serveur académique Lausannois, ID : 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 (r s ) 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.
