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

• 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
• 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

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.

项目摘要 FloBio LLC寻求开发一次性，易于使用，低血容量的微流控芯片， 快速检测新生儿和儿科患者的血小板功能，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分析， 监测不同疾病和药物条件下的血液功能。利用超过 在蛋白质微图案化、微流体、新型荧光生物传感器 和患者血液检测，该团队将把繁琐的基于PDM的研究 将各种方法转化为护理点（POC）一次性芯片，允许可扩展的制造， 可靠的床边使用。这种一次性使用的芯片将被应用于快速病人监测， 在新生儿和儿科血液检测的背景下， 可供分析。在先天性心脏病修复、膜肺氧合等领域 以及必须在手术期间控制血栓形成风险的心室辅助装置， 微流体技术对于在血液动力学条件下测试血液功能是理想的。Flobio将 实施第一阶段研究，具体目标如下。目标1：内部优化 用于新生儿应用的全血凝固的校准物和药理学测试。目标二： FloBio芯片和新生儿试剂混合物在6个月内的稳定性测试。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，用于芯片阅读的β单元将 将开发更大的芯片制造运行，以部署在临床 美国的研究中心，用于检测新生儿和儿科患者的血液。随着时间的推移， FloBio芯片还可以帮助降低临床中新生儿/儿科出血或血栓形成的风险 肿瘤学、急诊医学或血友病领域。