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

急性肾损伤（AKI）发生在5-7%的住院患者中，其死亡率约为50%。一个特别令人不安的特征是，自20世纪60年代中期以来，无法大幅降低AKI的死亡率。AKI的财务成本估计为每年80亿美元，或每个生命年节省约13万美元。在有更好的早期诊断肾损伤的工具之前，这种高死亡率和相关费用不太可能降低。因此，迫切需要开发临床有效的方法来检测早期急性肾功能衰竭。这个NSF I-Corps项目旨在探索和评估“急性肾脏感染的量热诊断仪器”的商业化潜力，该仪器是由NSF早期资助的研究计划设计的。具体来说，该仪器将基于石英谐振器的热生物传感器概念纳入生物医学仪器系统，用于基于尿肌酐排泄测量的肾功能连续监测。利用石英量热装置，该团队开发了一种生物传感系统，以近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、电子设备和一个可复制的流体盒组成，该流体盒内装有固定化酶。将传感器及其电子元件与感兴趣的分析物分离的想法不仅提供了测量优势，而且可以显着节省成本。与其扔掉昂贵的与固定化酶缠绕在一起的传感器，倒不如提议的操作方案允许传感器系统无限期地使用，只有含有固定化酶的流体管可以很容易地交换。因此，这种设计适合类似于葡萄糖传感器的商业化模式。该团队计划在I-Corps项目期间总结并整合来自客户访谈的各种建议，以构建beta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.