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Paper-based high shear hemostatic analytical device

纸基高剪切止血分析装置

基本信息

批准号：
10649056
负责人：
David Bark
金额：
$ 20.32万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-07-01 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10649056
关键词：
Anticoagulants Arrhythmia Biological Assay Biological Markers Blood Blood Glucose Blood Platelets Blood Tests Blood Transfusion Blood coagulation Blood flow Blood specimen COVID-19 Capital Cardiovascular Diseases Cause of Death Characteristics Coagulation Process Collagen Consumption Coronary Arteriosclerosis Data Defect Dependence Devices Diagnostic Equipment Disease Drops Drug Costs Electricity Environment Equipment Extracorporeal Membrane Oxygenation Feedback Fibrinolytic Agents Generations Goals Growth Health Health Care Costs Hemorrhage Hemostatic Agents Hemostatic function Hospitals Infection Injury Ischemia Life Medical Device Microfluidics Modeling Monitor Nature Operative Surgical Procedures Outcome Paper Pathway interactions Patients Persons Pharmaceutical Preparations Point of Care Technology Porosity Process Resource-limited setting Resources Sampling Secondary to Sensitivity and Specificity Severities Speed Stenosis Technology Testing Thromboplastin Thrombosis Thrombus Time Tissues Transfusion Trauma Warfarin Work antigen test blood product clinically relevant combat cost cost effective experimental study health disparity improved inhibitor innovation light weight low and middle-income countries operation point of care point-of-care diagnostics portability prevent response rural area rural health clinic skills test strip thrombotic tool user-friendly

项目摘要

PROJECT SUMMARY/ABSTRACT There are many diseases (e.g. arrhythmias, coronary artery disease, and infections) and situations (e.g. medical devices, trauma, and surgery) that require rapid and accurate point-of-care hemostatic tests, especially when regulating antithrombotics or after a blood transfusion. However, there are few options in resource-limited environments like low- and middle-income countries (LMICs), rural clinics, combat environments, and many others. This is because current hemostatic assays require electrical power, capital expense, skilled technicians, large equipment, and can be slow. As cardiovascular disease increases in LMICs, there is an urgent need to provide innovative tools for these lower resource environments. As an alternative, microfluidic-paper based analytical devices (PAD)s have been developed for low resource settings as a point-of-care technology since these are rapid, cost-effective, portable, disposable, eas-to-use, and typically require electricity. Such devices include the rapid antigen tests developed for COVID-19, which provide critical rapid feedback for making educated health decisions. These can be used almost anywhere with relatively little skill. Our goal is to develop a similar point-of-care tool that we call the Paper-based Clotting Analysis Test (P-CAT). Current PADs are limited for hemostatic analysis since they typically produce low flow conditions that can’t test many of the processes/pathways in primary hemostasis. We have developed a fast-flow PAD that will be incorporated into the P-CAT, enabling us to investigate the spectrum of pathways involved in hemostasis with only a drop (microliters) of blood. P-CATs can be created rapidly and at very little cost, thereby producing high throughput data. Here, we will develop the P-CAT to test blood samples with high specificity and and sensitivity to 1) pathways in primary (platelet-dependent) hemostasis, and 2) intrinsic and extrinsic coagulation cascades in secondary hemostasis. If successful, we will expand upon the P-CAT to incorporate additional biomarkers in an automated point-of-care device that could have a major impact on enabling portable, rapid, and inexpensive tests for hemostasis that can be widely distributed.

项目摘要/摘要有许多疾病(例如心律失常、冠状动脉疾病和感染)和情况(例如：医疗设备、创伤和手术)，需要快速和准确的护理点止血测试，尤其是在调节抗血栓药或输血后。然而，选择不多。在资源有限的环境中，如低收入和中等收入国家(LMIC)、农村诊所、战斗环境，以及许多其他环境。这是因为目前的止血分析需要电力，资金开支大，技术熟练的技术人员多，设备大，而且速度慢。作为心血管疾病 LMIC的增加，迫切需要为这些较低的资源提供创新的工具环境。作为替代，微流控纸基分析装置(Pad)S已经被作为一种护理点技术，为低资源设置而开发，因为这些技术快速、经济便携式、一次性、易于使用，通常需要电力。这样的装置包括快速抗原为新冠肺炎开发的测试，为健康教育提供关键的快速反馈决定。它们几乎可以在任何地方使用，只需相对较少的技能。我们的目标是开发类似的护理点工具，我们称之为纸基凝血分析测试(P-CAT)。当前的焊盘是止血分析受到限制，因为它们通常产生的低流量条件无法测试许多一期止血的过程/途径。我们已经开发出一种快速流动的垫，它将整合到P-CAT中，使我们能够研究参与的通路的光谱仅用一滴(微升)血来止血。P-CAT可以以很低的成本快速创建，从而产生高吞吐量数据。在这里，我们将开发P-CAT来检测血液样本对1)主要(血小板依赖)止血途径的高度特异性和敏感性，以及2) 内源性凝血和外源性凝血在继发性止血中级联作用。如果成功，我们将扩大在P-CAT上将额外的生物标记物整合到自动化护理点设备中，该设备可以对实现便携、快速和廉价的止血测试产生重大影响分布广泛。