I-Corps: Calorimetric Diagnostic Instrument for Acute Kidney Infection Monitoring

急性肾损伤(AKI)占住院患者的5-7%，死亡率约为50%。一个特别令人不安的特征是，自20世纪60年代中期以来，AKI一直无法大幅降低死亡率。据估计，AKI每年的财务成本为80亿美元，或者说每个节省下来的生命年大约13万美元。在有了更好的肾损伤早期诊断工具之前，这种高死亡率和相关成本不太可能降低。因此，迫切需要开发临床上有效的手段来检测早期急性肾功能衰竭。美国国家科学基金会I-Corps项目旨在探索和评估“急性肾脏感染热量诊断仪器”的商业化潜力，该仪器是从美国国家科学基金会资助的早期研究提案中设计出来的。具体地说，该仪器将基于石英谐振器的热式生物传感器概念引入到生物医学仪器系统中，用于基于尿肌酐排泄的连续监测肾功能。使用基于石英的量热设备，该团队开发了一种生物传感器系统，以几乎连续的方式量化尿中肌酐的浓度。该生物传感器由微型泵、石英谐振器传感器、电子器件和装满固定化酶的可复制的射流柱组成。将传感器及其电子设备与感兴趣的分析物分离的想法不仅在测量中提供了优势，而且允许显著节省成本。拟议的操作方案不需要丢弃与固定化酶交织在一起的昂贵传感器，而是允许传感器系统无限期使用，只需轻松更换包含固定化酶的射流管。因此，这种设计适合于一种类似于葡萄糖传感器的商业化模型。该团队计划在i-Corps计划期间总结和纳入客户采访的各种建议，以构建测试版原型。

Acute kidney injury (AKI) occurs in 5-7% of hospitalized patients and results in a mortality rate of about 50%. A particularly disturbing feature has been the inability since the mid-1960s to substantially lower mortality rates in AKI. 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 better tools for the early diagnosis of renal injury are available. Accordingly, a critical need exists to develop clinically efficient means for the detection of early acute renal failure. This NSF I-Corps project aims to explore and evaluate the commercialization potential of the "Calorimetric Diagnostic Instrument for Acute Kidney Infection" that has been engineered from an earlier NSF funded research proposal. Specifically, the proposed instrument involves a quartz resonator based thermal biosensor concept into a biomedical instrumentation system for continuous monitoring of kidney function based on the measurement of urinary creatinine excretion.Using the quartz based calorimetric device, the team has developed a biosensing system to quantify the concentration of creatinine in urine in a near continuous fashion. The biosensor consists of miniaturized pumps, quartz resonator sensor, electronics, and a replicable fluidic cartridge packed with immobilized enzyme. The idea of having the sensor and its electronics separated from the analyte of interest not only provides advantages in measurements but allows for significant cost savings. Rather, than having to throw away expensive sensors intertwined with the immobilized enzyme, the proposed operational scheme allows for the sensor system to be used indefinitely with only the fluidic tubing containing immobilized enzyme being easily swapped. Hence this design lends itself to a commercialization model akin to the glucose sensor. The team plans to summarize and incorporate the various suggestions from customer interviews during the I-Corps program to build a beta-prototype.