PDF(Pubmed)
Abstract：
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.
摘要：
用于测定所有抗Xa抑制剂的通用校准器将支持实验室过程。我们旨在使用通用edoxaban校准器测试抗Xa测定的临床表现，以确定所有抗Xa抑制剂的临床相关浓度。经过一项试点研究，我们招募了553名连续服用利伐沙班的患者，edoxaban,在一项前瞻性横断面研究中，来自9个研究中心的阿哌沙班。使用Technoview®edoxaban校准器进行Technochrom®抗Xa测定。采用超高效液相色谱-串联质谱(LC-MS/MS),测定抗Xa抑制剂药物浓度。确定了检测三种临床相关药物浓度（30μgL-1、50μgL-1、100μgL-1）的敏感性和特异性。总的来说,300例患者接受利伐沙班治疗，221与阿哌沙班，和32与edoxaban包括在内。总相关系数(rs)为0.95(95%CI0.94,0.96)。对于30µgL-1，接收器工作特性曲线下的面积为0.96，对于50µgL-1为0.98，对于100µgL-1为0.99。敏感性为92.3%(95%CI89.2，94.6)，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,一个普遍的临床表现，依度沙班校准的抗Xa测定是固体的，大多数药物浓度预测正确。
