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
Department of Clinical Chemistry, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.
Division of Medical Oncology and Hematology, University Hospital Zurich, University of Zurich, 8006 Zurich, Switzerland.
Diagnostics (Basel). 2023 Jun 20;13(12):2128. doi: 10.3390/diagnostics13122128.
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, 50 µgL, 100 µgL) were determined. Overall, 300 patients treated with rivaroxaban, 221 with apixaban, and 32 with edoxaban were included. The overall correlation coefficient (r) was 0.95 (95% CI 0.94, 0.96). An area under the receiver operating characteristic curve of 0.96 for 30 µgL, 0.98 for 50 µgL, and 0.99 for 100 µgL 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.
一种用于测定所有抗Xa因子抑制剂的通用校准物将有助于实验室检测流程。我们旨在测试一种使用通用依度沙班校准物的抗Xa因子检测方法的临床性能，以测定所有抗Xa因子抑制剂的临床相关浓度。在一项初步研究之后，我们在一项前瞻性横断面研究中，从9个研究中心连续纳入了553例服用利伐沙班、依度沙班或阿哌沙班的患者。使用Technoview依度沙班校准物进行Technochrom抗Xa因子检测。采用超高效液相色谱-串联质谱法（LC-MS/MS）测定抗Xa因子抑制剂药物浓度。确定了检测三种临床相关药物浓度（30μg/L、50μg/L、100μg/L）的灵敏度和特异性。总体而言，纳入了300例接受利伐沙班治疗的患者、221例接受阿哌沙班治疗的患者和32例接受依度沙班治疗的患者。总体相关系数（r）为0.95（95%CI 0.94，0.96）。发现30μg/L时的受试者工作特征曲线下面积为0.96，50μg/L时为0.98，100μg/L时为0.99。灵敏度分别为92.3%（95%CI 89.2，94.6）、92.7%（89.4，95.1）和94.8%（91.1，97.0）（特异性分别为82.2%、93.7%和94.4%）。总之，一种通用的、以依度沙班校准的抗Xa因子检测方法的临床性能可靠，大多数药物浓度都能被正确预测。
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