Point-of-care device for testing neonate platelet function

用于测试新生儿血小板功能的即时护理设备

基本信息

批准号：
10010629
负责人：
Jason M Rossi
金额：
$ 25.16万
依托单位：
FLOBIO, LLC
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-22 至 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10010629
关键词：
Adult Anticoagulants Antiplatelet Drugs Area Aspirin Automation Biological Assay Biology Biosensor Birth Blood Blood Platelets Blood Tests Blood Volume Blood coagulation Blood specimen Calibration Centers for Disease Control and Prevention (U.S.)Child Childhood Clinical Clinical Research Coagulation Process Collagen Color Common Ventricle Congenital Heart Defects Cyclooxygenase Inhibitors Data Analyses Deposition Detection Development Devices Diamond Disease Drug usage Emergency Medicine Ensure Event Extracellular Matrix Fibrin Fibrinogen Fluorescence Fluorescent Antibody Technique Generations Goals Hemophilia A Hemorrhage Hemostatic function Image Injections Lung Membrane Microfluidic Microchips Microfluidics Molds Monitor Neonatal Oncology Operative Surgical Procedures Optics Oral Outcome Output Patient Monitoring Patients Pediatric Hospitals Pennsylvania Pharmaceutical Preparations Pharmacology Phase Philadelphia Physiological Platelet Activation Population Prevention Production Proteins Protocols documentation Publications Quantum Dots Reader Reading Reagent Research Research Methodology Research Personnel Risk Running Sampling Shipping Shunt Device Signal Transduction Site Slide Syndrome System Technology Testing Therapeutic Thromboembolism Thromboplastin Thrombosis Time Treatment Efficacy Universities Validation Whole Blood base cardiac repair clinical care clinical research site clinically relevant congenital heart disorder design experience graphical user interface hemodynamics inhibitor/antagonist instrument interest manufacturing scale-up neonatal death neonatal patient neonatal surgery neonate novel operation pediatric patients platelet function point of care point-of-care diagnostics preclinical study rapid detection repaired response screening seal software development stability testing statistics transmission process user-friendly ventricular assist device

项目摘要

PROJECT SUMMARY FloBio LLC seeks to develop disposable, easy-to-use, low blood volume microfluidic chips for rapid detection of platelet function in neonatal and pediatric patients in order to guide safe use of anti-platelet agents during neonatal surgery and therapies. FloBio LLC, in conjunction with researchers at the University of Pennsylvania, has pioneered low volume microfluidic assays to monitor blood function under diverse disease and pharmacological conditions. Utilizing over a decade of experience with protein micropatterning, microfluidics, novel fluorescent biosensors, and patient blood testing, the team will convert cumbersome PDMS-based research methodologies into point-of-care (POC) disposable chips that allow scalable manufacturing and reliable bedside use. Such single-use chips will be applied to rapid patient monitoring in the context of neonatal and pediatric blood testing where only extremely small blood volumes are available for analysis. In areas such as congenital heart disease repair, membrane oxygenation and ventricle assist devices where thrombotic risks must be managed during surgery, microfluidics are ideal for testing blood function under hemodynamic conditions. FloBio will implement Phase I research on the following specific aims. Aim 1: Optimization of internal calibrants and pharmacological testing for whole blood clotting for neonate applications. Aim 2: Stability testing of FloBio chips and neonate reagent cocktails over 6 months. Aim 3: Development of neonate assay analytics and user-friendly interface. In Phase II, beta-units for chip reading will be developed and larger chip manufacturing runs will be implemented for deployment at clinical sites in the US for testing with blood obtained from neonatal and pediatric patients. In time, the FloBio chip may also help reduce risks of neonatal/pediatric bleeding or thrombosis in the clinical arenas of oncology, emergency medicine, or hemophilia.

项目概要 FloBio LLC 致力于开发一次性、易于使用、低血容量的微流控芯片，用于快速检测新生儿和儿童患者的血小板功能，以指导安全使用新生儿手术和治疗期间的抗血小板药物。 FloBio LLC 与宾夕法尼亚大学的研究人员开创了低容量微流体测定法监测不同疾病和药理学条件下的血液功能。利用超过在蛋白质微图案、微流体、新型荧光生物传感器、和患者血液检测，该团队将转换繁琐的基于 PDMS 的研究将方法论融入即时护理 (POC) 一次性芯片中，从而实现可扩展的制造和可靠的床边使用。这种一次性芯片将应用于快速患者监测新生儿和儿科血液检测的背景下，仅需要极少量的血量可用于分析。先天性心脏病修复、膜氧合等领域以及手术期间必须控制血栓风险的心室辅助装置，微流体是血流动力学条件下测试血液功能的理想选择。弗洛比奥将针对以下具体目标实施第一阶段研究。目标1：内部优化新生儿全血凝固的校准物和药理学测试。目标 2：对 FloBio 芯片和新生儿混合试剂进行 6 个月以上的稳定性测试。目标 3：发展新生儿检测分析和用户友好的界面。在第二阶段，用于芯片读取的 beta 单元将进行开发并实施更大规模的芯片制造，以用于临床部署美国的一些站点使用从新生儿和儿科患者身上采集的血液进行检测。随着时间的推移， FloBio芯片还可能有助于降低临床中新生儿/儿童出血或血栓形成的风险肿瘤学、急诊医学或血友病领域。