Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Vitalant Coagulation Laboratory, Pittsburgh, PA, USA.
Am J Clin Pathol. 2022 Mar 3;157(3):457-469. doi: 10.1093/ajcp/aqab149.
This study established the performance characteristics of DOAC-Remove for neutralization of the effects of rivaroxaban and apixaban in lupus anticoagulant (LAC) testing.
Normal donor, LAC control, and patient samples were spiked with rivaroxaban or apixaban to simulate their effects on the dilute Russell's viper venom time (dRVVT), activated partial thromboplastin time (APTT), and dilute prothrombin time (dPT). Anti-Xa activity was measured after spiking and after DOAC-Remove neutralization. Accuracy, complex precision, and reference interval verification were evaluated.
DOAC-Remove neutralized rivaroxaban and apixaban concentrations as high as 415 ng/mL and 333 ng/mL, respectively. Percentage positive and negative agreement between the baseline and postneutralization interpretations were 75% or higher for the dRVVT and APTT methods but not for the dPT method. Coefficients of variation (CVs) were 10% or less for all assays except the Staclot-LA delta, which had a standard deviation of 2.5 seconds or CV of 25% or less depending on the level. The laboratory's reference intervals were verified for the dRVVT and APTT assays after DOAC-Remove treatment but not for the dPT assays.
DOAC-Remove appears to have acceptable performance characteristics for neutralizing the effects of rivaroxaban and apixaban in the dRVVT and APTT methods but not in the dPT method.
本研究旨在建立 DOAC-Remove 中和利伐沙班和阿哌沙班在狼疮抗凝物（LAC）检测中的作用的性能特征。
向正常供体、LAC 对照和患者样本中加入利伐沙班或阿哌沙班，以模拟它们对稀释 Russell 蝰蛇毒时间（dRVVT）、活化部分凝血活酶时间（APTT）和稀释凝血酶原时间（dPT）的影响。加样后和 DOAC-Remove 中和后测量抗-Xa 活性。评估准确性、复杂精密度和参考区间验证。
DOAC-Remove 可中和高达 415 ng/mL 和 333 ng/mL 的利伐沙班和阿哌沙班浓度。dRVVT 和 APTT 方法的基线和中和后解释的阳性和阴性符合率为 75%或更高，而 dPT 方法则不然。除了 Staclot-LA delta，所有检测的变异系数（CV）均为 10%或更低，后者的标准偏差为 2.5 秒或 CV 为 25%或更低，具体取决于水平。在 DOAC-Remove 处理后，实验室的参考区间在 dRVVT 和 APTT 检测中得到验证，但在 dPT 检测中则没有。
DOAC-Remove 似乎具有可接受的性能特征，可中和 dRVVT 和 APTT 方法中利伐沙班和阿哌沙班的作用，但不能中和 dPT 方法。
