Mbroh Joshua, Birschmann Ingvild, Ebner Matthias, Kremer Hovinga Johanna A, Lindhoff-Last Edelgard, Purrucker Jan, Schäfer Simon T, Tünnerhoff Johannes, Wang Yi, Poli Sven
Department of Neurology & Stroke, University of Tübingen, Tübingen, Germany.
Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany.
Eur Stroke J. 2025 Apr;10(1_suppl):24-34. doi: 10.1177/23969873241310359. Epub 2025 May 22.
To provide an overview on commercially available point-of-care tests (POCT) for rapid assessment of direct oral anticoagulant (DOAC) activity, their diagnostic accuracy in identifying blood samples containing clinically relevant DOAC concentrations, and guidance on selecting the appropriate POCT system/assay for decision-making in emergencies.
Systematic review with PubMed and Cochrane library search for published studies until September 6, 2024. Papers were included if in English, original research using blood samples from DOAC patients and POCT was implemented. Two reviewers assessed studies for eligibility and quality. Data from studies were aggregated and diagnostic accuracy at DOAC plasma thresholds of 30/50/100 ng/ml was recalculated.
16 studies involving four commercially available POCT systems/assays were identified. Eleven studies evaluated blood-based POCT and five used urine for indirect estimation of DOAC plasma levels.
DOAC Dipsticks do not require knowledge about the taken DOAC, but measure urine and, due to low specificity, require blood testing in case of positive results. Hemochron Signature Elite (HSE) and CoaguChek use global coagulation assays and provide high sensitivity for edoxaban and rivaroxaban, HSE additionally for dabigatran. Due to insufficient correlation, both POCT are not recommended for apixaban, CoaguChek also not for dabigatran. The thromboelastometric ClotPro performs well for all DOAC, does not require knowledge about the DOAC, but was taken off the market recently.
Studies have shown feasibility of POCT in identifying blood samples containing clinically relevant DOAC plasma concentrations. Each POCT device has its own unique limitations. Knowledge about the POCT assays, time since last intake and type of DOAC enhances confidence in making appropriate therapeutic decisions. We propose an algorithm that could help guiding physicians in selecting an appropriate POCT system/assay in DOAC-related emergencies.
概述用于快速评估直接口服抗凝剂(DOAC)活性的商用即时检验(POCT)、其在识别含有临床相关DOAC浓度的血样中的诊断准确性,以及为在紧急情况下进行决策选择合适的POCT系统/检测方法提供指导。
通过PubMed和Cochrane图书馆检索已发表的研究,检索截至2024年9月6日。纳入的论文需为英文,使用来自DOAC患者血样的原始研究且实施了POCT。两名评审员评估研究的 eligibility 和质量。汇总研究数据并重新计算DOAC血浆阈值为30/50/100 ng/ml时的诊断准确性。
确定了16项涉及四种商用POCT系统/检测方法的研究。11项研究评估了基于血液的POCT,5项使用尿液间接估计DOAC血浆水平。
DOAC试纸条不需要了解所服用的DOAC,但检测尿液,由于特异性低,阳性结果时需要进行血液检测。Hemochron Signature Elite(HSE)和CoaguChek使用整体凝血检测方法,对依度沙班和利伐沙班具有高灵敏度,HSE还对达比加群具有高灵敏度。由于相关性不足,两种POCT均不推荐用于阿哌沙班,CoaguChek也不推荐用于达比加群。血栓弹力图ClotPro对所有DOAC表现良好,不需要了解DOAC,但最近已退出市场。
研究表明POCT在识别含有临床相关DOAC血浆浓度的血样方面具有可行性。每种POCT设备都有其独特的局限性。了解POCT检测方法、上次服药后的时间以及DOAC的类型可增强做出适当治疗决策的信心。我们提出了一种算法,可帮助指导医生在DOAC相关紧急情况中选择合适的POCT系统/检测方法。