背景:直接口服抗凝剂(DOAC)反映了用于治疗或预防血栓形成的抗凝剂,已在很大程度上替代了维生素K拮抗剂(VKAs),如华法林。DOAC以固定的日剂量给予并且通常不需要监测。然而,可能有多种原因证明测量个体患者的血浆DOAC水平是合理的.
方法:我们报告了我们地理区域DOAC测试的最新发现,使用RCPAQAP的最新数据,国际外部质量评估(EQA)计划,目前,每个不同的DOAC(利伐沙班,阿哌沙班,达比加群)模块,评估该领域的实验室性能。对过去5年的数据进行了评估(含2019-2023年),每个DOAC有20个样本。
结果:数据显示使用的分析库有限,在评估熟练程度样本时,报告的数值大多是一致的。可用的测定主要包括来自四个制造供应商的试剂。参与者确定为“DOAC检测到”的内容具有良好的一致性,但当参与者试图将DOAC水平分级为低、中、高时,存在一定的差异。每个DOAC的实验室间/方法变异系数(CV)通常<15%,当存在于>100ng/mL时。
结论:我们希望我们的发现,反思DOAC水平和解释的大多数一致报告为要求这些测量的临床医生提供了保证,并帮助在缺乏测试可用性的地区支持它们的实施。
BACKGROUND: Direct oral anticoagulants (DOACs) reflect anticoagulation agents given to treat or prevent thrombosis, having largely replaced vitamin K antagonists (VKAs) such as warfarin. DOACs are given in fixed daily doses and generally do not need monitoring. However, there may be a variety of reasons that justify measurement of plasma DOAC levels in individual patients.
METHODS: We report updated findings for DOAC testing in our geographic region, using recent data from the RCPAQAP, an international external quality assessment (EQA) program, currently with some 40-60 participants in each of the different DOAC (rivaroxaban, apixaban, dabigatran) modules, to assess laboratory performance in this area. Data has been assessed for the past 5 years (2019-2023 inclusive), with 20 samples each per DOAC.
RESULTS: Data shows a limited repertoire of assays in use, and mostly consistency in reported numerical values when assessing proficiency samples. Available assays mostly comprised reagents from four manufacturing suppliers. There was good consistency across what participants identified as \'DOAC detected\', but some variability when participants attempted to grade DOAC levels as low vs moderate vs high. Inter-laboratory/method coefficient of variation (CVs) were generally <15% for each DOAC, when present at >100 ng/mL.
CONCLUSIONS: We hope our findings, reflecting on mostly consistent reporting of DOAC levels and interpretation provides reassurance for clinicians requesting these measurements, and helps support their implementation in regions where there is a paucity of test availability.