PFI:AIR - TT: Continuous Urine Assay Instrumentation for Monitoring Kidney Function

PFI:AIR - TT：用于监测肾功能的连续尿液分析仪器

• 批准号: 1601385
• 负责人: Srinivas Tadigadapa
• 金额: $ 20万
• 依托单位: Pennsylvania State Univ University Park
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1601385&HistoricalAwards=false
• 关键词: PFI; AIR; TT; Continuous; Urine

This PFI: AIR Technology Translation project focuses on a technology to address the detection of early acute kidney injury (AKI). AKI occurs in 5 - 7% of hospitalized patients and results in a mortality rate of about 50%. The financial costs of AKI are estimated to be 8 billion dollars per year, or about $130,000 per life-year saved. It is unlikely that this high mortality and associated cost will be reduced until there are better tools for the early diagnosis of renal injury. This project translates a quartz resonator based thermal biosensor concept into a biomedical instrumentation system for continuous monitoring of kidney function. The project will focus on prototype engineering, instrumentation, and extensive benchmarking with the aim to provide accurate and automated measurements of urine creatinine. Coupled with in-line urine flow, and periodic serum creatinine concentration measurements, a system for near-continuous creatinine clearance measurement in AKI patients will be developed. The unmatched stability, sensitivity, and reproducibility of this system will allow for collection of such data for clinical analysis and early detection of conditions such as sepsis. The sensor design based on enzyme immobilized alginate beads placed in a Kapton® tubing, as an easy to swap disposable cartridge represents a promising clinical diagnostic prototype demonstration with a viable business model.This project will develop a calorimetric biosensor prototype based upon differential measurement as a way to compensate for background thermal effects. Development of a differential sensor is expected to improve both the sensitivity and the precision of measurement. The reproducibility, accuracy, and stability of the measurement system will be critically evaluated using urine samples. Intra-assay and inter-assay variability will be experimentally determined by repeated measurements and statistical methods. Accuracy will be determined by comparison of the creatinine concentrations determined by HPLC (the gold standard) and the quartz resonator. Agreement between the two methods will be determined by Bland-Altman analysis. Stability of the system will be determined by measuring the creatinine concentration of known creatinine test solutions at regular intervals over a period of 48 hours. The plot of measured concentration vs time will be used to determine the time to failure. In addition, personnel involved in this project, one graduate and one undergraduate student, will receive regulatory compliance experiences through collaboration with our partner company focused on improving patient outcomes through the successful implementation of innovative technology into medical devices. The team will be also participate in several commercialization conferences and events to establish strategic alliances and partnerships for the technology translation and commercialization.

这项PFI：空气技术翻译项目的重点是解决早期急性肾脏损伤（AKI）的技术。 AKI发生在5-7％的住院患者中，导致死亡率约为50％。 AKI的财务成本估计为每年80亿美元，每年节省的年龄约为130,000美元。在有更好的早期诊断肾脏损伤的工具之前，这种高死亡率和相关成本不可能降低。该项目将基于石英谐振器的热生物传感器概念转化为生物医学仪器系统，以连续监测肾功能。该项目将着重于原型工程，仪器和广泛的基准测试，以提供准确，自动化的尿液创建测量。结合在线尿流和周期性的血清Crectionine浓度测量值，将开发出AKI患者中接近连续的肌酐清除率测量的系统。该系统的无与伦比的稳定性，敏感性和可重复性将允许收集此类数据，以进行临床分析和及早检测诸如败血症之类的疾病。 The sensor design based on enzyme immobilized algorithm beads placed in a Kapton® tubing, as an easy to swap disposable cartridge represents a promising clinical diagnostic prototype demonstration with a viable business model.This project will develop a calolimetric biosensor prototype based upon differential measurement as a way to compensate for background thermal effects.预计差异传感器的开发将提高测量的灵敏度和精度。测量系统的可重复性，准确性和稳定性将使用尿液样本进行严格评估。测定和测定间变异性将通过重复测量和统计方法在实验中确定。通过比较由HPLC（黄金标准）和石英谐振器比较的肌氨酸浓度来确定精度。两种方法之间的一致性将通过Bland-Altman分析确定。系统的稳定性将通过在48小时的时间内定期测量已知Creationine测试溶液的肌酐浓度来确定。测得的浓度与时间的图将用于确定失败的时间。此外，参与该项目的人员，一名毕业生和一名本科生，将通过与我们的合作伙伴公司的合作来获得监管合规经验，该公司致力于通过成功实施创新技术来改善患者成果，以改善患者的成果。该团队还将参加几次商业化会议和活动，以建立技术翻译和商业化的战略联盟和合作伙伴关系。