Determination of Anti-Xa Inhibitor Plasma Concentrations Using a Universal Edoxaban Calibrator - Burger, A.; Studt, J. D.; Mendez, A.; Alberio, L.; Fontana, P.; Wuillemin, W. A.; Schmidt, A.; Graf, L.; Gerber, B.; Bovet, C.; Sauter, T. C.; Binder, N. B.; et al. (Diagnostics (Basel), 2023)
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((R)) anti-Xa assay was conducted using the Technoview((R)) 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 microgL(-1), 50 microgL(-1), 100 microgL(-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 microgL(-1), 0.98 for 50 microgL(-1), and 0.99 for 100 microgL(-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.
Keywords: journalArticle; Bayer, Pfizer, and from Alexion Pharma GmbH, all outside the submitted work. JDS; Bristol Myers Squibb, Daiichi-Sankyo, Takeda, Octapharma, SOBI, Janssen, Novo; Fisher Scientific, during the conduct of the study; Nordisk, and Mitsubishi Tanabe Pharma, outside the submitted work. NBB is an; Takeda, Siemens, and Sanofi. TCS holds an endowed professorship supported by the; Touring Club Switzerland. BG reports non-financial support and funding for an; WAW reports research grants from Bayer Healthcare, BMS-Pfizer, Daiichi Sankyo,; accredited continuing medical education program from Axonlab, and from Thermo; an accredited continuing medical education program from Alnylam; and Sanofi, and honoraria for participating in scientific advisory boards from; anti-Xa assay; anticoagulants introduction; apixaban; diagnostic accuracy; edoxaban; employee and stakeholder of Technoclone; fees and funding for accredited continuing medical education program from Pfizer; funding for an accredited continuing medical education program from Bayer,; grants from Bayer, CSL-Behring, Novartis, Novo Nordisk, Roche, Sobi, and Takeda; grants, personal; laboratory monitoring; lecture honoraria from Bayer Healthcare, and Daiichi Sankyo. LA reports research; personal fees and funding for; reports lecture fees and advisory honoraria from Bayer Healthcare, Pfizer,; rivaroxaban