Baker Steven Andrew, Jin Jing, Pfaffroth Christopher, Vu Trang, Zehnder James L
Department of Pathology Stanford University School of Medicine Stanford CA USA.
Department of Special Coagulation Clinical Laboratory Stanford Health Care Palo Alto CA USA.
Res Pract Thromb Haemost. 2021 Jan 27;5(2):314-325. doi: 10.1002/rth2.12472. eCollection 2021 Feb.
The use of direct oral anticoagulants (DOACs) is a convenient therapeutic option for patients at risk of thrombosis. DOACs interfere with clot-based testing for the identification of lupus anticoagulant antibodies (LACs) in patients with antiphospholipid syndrome (APS), a common cause of acquired thrombotic disease.
To evaluate a commercially available reagent DOAC-Stop for the removal of DOAC interference encountered in LAC testing.
PATIENTS/METHODS: We collected a cohort of 73 test samples from patients on DOAC therapy identified at a large institutional coagulation laboratory from March to December 2019, along with samples from 40 LAC positive and negative control patients not on therapy. Samples were treated with DOAC-Stop and tested for anti-Xa activity and thrombin time for the removal of apixaban, rivaroxaban, argatroban, and dabigatran activity from patient samples. Treated and untreated samples were tested using the activated partial thromboplastin time, silica clotting time, and dilute Russell's viper venom time to evaluate the reliability and utility of DOAC-Stop.
DOAC-Stop markedly reduced DOAC interference from test samples ( < .05). DOAC-Stop had no effect on LAC testing in the absence of DOAC therapy, permitting the identification of all LAC positive and negative controls. DOAC-Stop removed false positives and false negatives resulting from DOAC interference and allows the identification of patients meeting criteria for the diagnosis of APS by LAC testing, as well as the detection of patients on rivaroxaban who are triple positive for APS.
DOAC-Stop is an effective adjunct for the clinical laboratory faced with DOAC interference in LAC testing.
对于有血栓形成风险的患者，使用直接口服抗凝剂（DOACs）是一种便捷的治疗选择。DOACs会干扰基于凝血块的检测，影响抗磷脂综合征（APS，一种获得性血栓形成疾病的常见病因）患者狼疮抗凝抗体（LACs）的鉴定。
评估一种市售试剂DOAC-Stop，以消除LAC检测中遇到的DOAC干扰。
患者/方法：我们从一家大型机构凝血实验室收集了2019年3月至12月接受DOAC治疗的患者的73份检测样本，以及40名未接受治疗的LAC阳性和阴性对照患者的样本。样本用DOAC-Stop处理，检测抗Xa活性和凝血酶时间，以去除患者样本中的阿哌沙班、利伐沙班、阿加曲班和达比加群活性。使用活化部分凝血活酶时间、硅土凝血时间和稀释蝰蛇毒时间对处理和未处理的样本进行检测，以评估DOAC-Stop的可靠性和实用性。
DOAC-Stop显著降低了检测样本中的DOAC干扰（P<0.05）。在没有DOAC治疗的情况下，DOAC-Stop对LAC检测没有影响，能够识别所有LAC阳性和阴性对照。DOAC-Stop消除了DOAC干扰导致的假阳性和假阴性，使得通过LAC检测能够识别符合APS诊断标准的患者，以及检测出利伐沙班治疗且APS三项指标均为阳性的患者。
对于面临LAC检测中DOAC干扰的临床实验室，DOAC-Stop是一种有效的辅助试剂。
