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新设备可能提供凝血能力的快速POC评估

By LabMedica International staff writers
Posted on 13 Jan 2017
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图片:便携式ClotChip将进行临床试验,进一步评估其在床旁护理中快速检测凝血的能力是否与实验室检查有可比性(照片由Case Western Reserve University提供)。
图片:便携式ClotChip将进行临床试验,进一步评估其在床旁护理中快速检测凝血的能力是否与实验室检查有可比性(照片由Case Western Reserve University提供)。
 研究人员已开发一种传感器,这种传感器开始接受性能检测,能准确评估凝血能力,检测速度比现有方法快95倍,只需要一滴血就能完成检测。该设备提供的信息还比现有的方法多。
这款新设备“ClotChip”由Case Western Reserve University(CWRU;Cleveland,OH,USA)的研究人员开发,能快速准确的评估为有凝血问题的患者提供适当护理所需的必要信息。XaTek是一家总部位于克立夫兰的新公司,已被授权使用ClotChip技术,本产品计划mini在3年内上市。
“ClotChip被设计为最大程度的减少血样制备的时间和所需的精力。该设备能在医生办公室或其他床旁护理情况下用于接受抗凝血治疗、抗血小板治疗或因外伤出血的患者,”CWRU的电气工程与计算机科学(EECS)教授、ClotChip的开发领导者Pedram Mohseni,与EECS高级研究员Michael Suster说明。
现有的检测通常需要患者到使用一种耗时而昂贵的检测方法的实验室完成,由专业技术人员进行检测。现有的少数方法允许现场检测,截至目前,其检测的精密度不及实验室检测方法。
初步检测中,ClotChip在15分钟内提供结果,相比之下,现有的检测方法可能需要1天甚至更长时间才能得出结果。该设备还能提供凝血过程相关的更多信息,包括一个相对新的药物类别的作用——靶向特定口服抗凝剂(TSOAC)。
TSOAC以不同于华法林(例如商品名为华法灵钠)的途径阻断凝血的形成。华法林能与多种药物和食物发生负面相互作用,并需要经常进行血液测试,以监控药物的作用。新药,包括利伐沙班(拜瑞妥)和阿哌沙班(艾乐妥),已上市,作为一种更方便的选择。但是,截至目前,美国食品药品管理局(FDA)还未批准一种检测确定新药影响的设备。
随着TSOAC的使用量越来越大,“有大量机会和需求”XaTek的CEO,John Zak说,“目前还没有监测这些药物的现实可用的床旁护理、具备成本收益和准确的方法。他说明,该公司希望完成一项初步临床研究,分析Louis Stokes Cleveland VA医疗中心截至2017年末200名患者使用ClotChip的数据。如果该设备在初始评价中被证实有效,XaTek将在接下来的两年内视图启动一个全面临床试验;并依此征得FDA的批准。
为监控凝血,ClotChip使用一种被称为小型介电谱的电气技术,这种方法由Mohseni教授、Suster博士和团队在6年前开始开发。本质上,该技术对血滴应用外电场,然后定量检测血液对电场的影响。该检测反应血液凝集的能力。然后他们开始与Case Western Reserve School of Medicine的血液肿瘤副教授Evi Stavrou合作。这三名研究人员还是Advanced Platform Technology(APT)研究中心的研究者。
该团队发现,ClotChip的血液凝集过程检测灵敏度令其成为床旁护理的一个很有吸引力的选择。“我们的设备为您提供不同的信息——比现有其他设备提供更多信息,”Stavrou教授说明,“与标准凝固试验相比,设备的灵敏度和分辨力让我兴奋不已。”而且该设备工作速度很快,急诊科能现场使用它确定创伤患者是否应使用血液稀释药物。如此重要的信息也可能在医药人员奋战中提供重要的价值。
Case Western Reserve University 

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