Taune Viktor, Skeppholm Mika, Ågren Anna, Wikman Agneta, Hillarp Andreas, Wallén Håkan
Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Karolinska Institutet, Stockholm, Sweden.
Division of Clinical Immunology and Transfusion Medicine, Department of Laboratory Medicine, Karolinska University Hospital, Stockholm, Sweden; Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.
TH Open. 2022 Aug 29;6(3):e238-e247. doi: 10.1055/s-0042-1751072. eCollection 2022 Jul.
A rapid test to detect apixaban treatment would be useful in acute situations such as major bleeding, urgent surgery, or in acute thrombosis. This article aims to study if the viscoelastic test rotational thromboelastometry (ROTEM) can rapidly detect apixaban in whole blood using modified triggers based on factor Xa (FXa) or Russell viper venom (RVV). ROTEM clotting time (CT) was measured in samples from 40 patients on apixaban treatment, and in vitro in samples spiked with apixaban (20-500 ng/mL). Commercially available trigger Ex-tem was compared with modified triggers based on FXa or RVV. Reversibility of apixaban in the samples was studied; CT was measured with and without addition of DOAC-Stop or andexanet alfa, respectively, and the difference in CT was calculated (CT ). Using FXa as trigger, we detected apixaban concentrations at 20 ng/mL and above with 100% sensitivity and 100% specificity in patient samples and in vitro. Corresponding data for Ex-tem were 92% sensitivity and 100% specificity in patients, and 94% sensitivity and 100% specificity in vitro, and for RVV 97% sensitivity and 94% specificity in patients, and 97% sensitivity and 100% specificity in vitro, respectively. CT data were similar. Patient sample data were obtained within 20 minutes from sampling. Apixaban at low therapeutic concentrations was detected within 20 minutes, and with high sensitivity and specificity. A trigger based on FXa outperformed the commercial trigger Ex-tem and a trigger based on RVV. ROTEM with a FXa-based trigger is a promising method to detect apixaban bedside in acute settings.
一种用于检测阿哌沙班治疗效果的快速检测方法在大出血、紧急手术或急性血栓形成等急性情况下将很有用。本文旨在研究黏弹性检测旋转血栓弹力图（ROTEM）是否能使用基于Xa因子（FXa）或罗素蝰蛇毒（RVV）的改良触发剂在全血中快速检测阿哌沙班。在40例接受阿哌沙班治疗的患者样本以及体外添加阿哌沙班（20 - 500 ng/mL）的样本中测量ROTEM凝血时间（CT）。将市售触发剂Ex-tem与基于FXa或RVV的改良触发剂进行比较。研究了样本中阿哌沙班的可逆性；分别在添加和不添加DOAC-Stop或andexanet alfa的情况下测量CT，并计算CT的差异（CT ）。使用FXa作为触发剂，我们在患者样本和体外检测阿哌沙班浓度在20 ng/mL及以上时，灵敏度和特异性均为100%。Ex-tem在患者中的相应数据为灵敏度92%、特异性100%，在体外为灵敏度94%、特异性100%；对于RVV，在患者中为灵敏度97%、特异性94%，在体外为灵敏度97%、特异性100%。CT 数据相似。患者样本数据在采样后20分钟内获得。低治疗浓度的阿哌沙班在20分钟内被检测到，且具有高灵敏度和特异性。基于FXa的触发剂优于市售触发剂Ex-tem和基于RVV的触发剂。基于FXa触发剂的ROTEM是在急性情况下床边检测阿哌沙班的一种有前景的方法。
