Point-of-care device for testing neonate platelet function

项目总结 FloBio LLC寻求开发一次性、易用、低血量的微流控芯片 快速检测新生儿和儿童患者的血小板功能以指导安全用药 新生儿手术和治疗中的抗血小板药物。FloBio LLC，与 宾夕法尼亚大学的研究人员开创了低容量微流控分析的先河 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、微流控、新型荧光生物传感器、 和患者血液检测，团队将转换繁琐的基于PDMS的研究 集成到护理点(POC)一次性芯片的方法，允许可扩展的制造和 可靠的床边使用。这种一次性使用的芯片将应用于快速患者监护 新生儿和儿童血液检测的背景下，只有极小的血量是 可供分析。在先天性心脏病修复、膜氧合等领域 以及在手术中必须控制血栓风险的脑室辅助装置， 微流体是在血液动力学条件下测试血液功能的理想选择。FloBio将 就以下具体目标实施第一阶段研究。目标1：内部优化 用于新生儿全血凝血的校准剂和药理学测试。目标2： FloBio芯片和新生儿试剂鸡尾酒的稳定性测试超过6个月。目标3：发展 新生儿化验分析和用户友好的界面。在第二阶段，用于芯片读取的测试版单位将 将开发和实施更大规模的芯片制造运行，以便在临床部署 在美国用新生儿和儿科病人的血液进行检测的地点。随着时间的推移， FloBio芯片还可能有助于降低临床上新生儿/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。

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.