Determination of Anti-Xa Inhibitor Plasma Concentrations Using a Universal Edoxaban Calibrator

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(& REG;) anti-Xa assay was conducted using the Technoview(& REG;) 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 & mu;gL(-1), 50 & mu;gL(-1), 100 & mu;gL(-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 & mu;gL(-1), 0.98 for 50 & mu;gL(-1), and 0.99 for 100 & mu;gL(-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.

Automated summary

The study tested the clinical performance of a universal anti-Xa assay using an edoxaban calibrator, which accurately determined the concentrations of all anti-Xa inhibitors. The assay showed a high sensitivity and specificity in predicting drug concentrations.