At-home Testing of Blood Sodium for Management of Diabetes Insipidus

项目摘要/摘要 中枢性尿崩症(DI)是一种罕见的疾病，由激素加压素缺乏引起。 每25,000人中就有1人受到影响。缺乏加压素的人很快就会有高钠水平，并 容易发生危险的脱水，导致频繁住院。对DI的治疗包括 药理上的加压素替代和小心地调节液体摄入。在对DI治疗不足的同时 导致高钠血症和脱水，过度治疗会导致低钠血症(低钠血症 血钠水平)，可导致癫痫发作、永久性神经损伤、多系统器官 损伤，甚至死亡。最佳依赖关系管理和预防的最大障碍 并发症和住院，是缺乏随时可用的、快速和准确的血钠 测量。患有严重DI的人经常去医院，钠水平恢复的延迟 由于无法进行快速检测，直接投资管理不善会导致可预防的并发症。的确有 因此，在目标儿童DI人群中，对家庭钠监测的大量未得到满足的需求也是如此 作为一种特别设计和批准用于家庭使用的钠监测器的激动人心的潜力。 目前可用的血液电解质分析仪都是昂贵的实验室仪器，可以在 体积比手指大得多，在家庭常规血钠检测中是不现实的。这个 该计划的总体目标是开发一种在家使用的、经济实惠的传感器产品，该产品可以准确地测量 血钠。一种快速而简单的量化血液钠水平的电化学测试符合 DI关怀中的关键需求。吉纳将开发一种手持式血钠监测仪并演示 用小容量指棒血容量(&lt；100微米L)定量测定钠，在宽线性范围内 范围为100-360毫米(正常范围为138-146毫米)。吉纳将使用修改后的离子选择电极(ISE) 一种方法，允许快速(单步)、无标签和无试剂操作，类似于血糖 测试。第一阶段可行性计划的目标是：1)开发一种经过改性的钠试纸 钠离子选择膜(ISM)配方；2)样品处理技术的发展和 用于现场操作的传感器校准；以及3)用于血液分析、血液检测的传感器 血浆样本，以及对照标准临床化学方法的基准性能。

PROJECT SUMMARY/ABSTRACT Central diabetes insipidus (DI), caused by a deficiency of the hormone vasopressin, is a rare disease that affects 1 in 25,000 individuals. Individuals who lack vasopressin can quickly have high sodium levels and are vulnerable to dangerous dehydration, leading to frequent hospitalizations. Treatment for DI includes pharmacologic vasopressin replacement and careful regulation of fluid intake. While under-treatment of DI causes hypernatremia (high blood sodium levels) and dehydration, over-treatment causes hyponatremia (low blood sodium levels), which can lead to seizures, permanent neurological injury, multi-system organ impairment, and even death. The most substantial barrier to optimal DI management, and to preventing complications and hospitalizations, is the lack of readily available, quick, and accurate blood sodium measurements. Individuals with severe DI travel to hospitals frequently and the delay in return of sodium levels due to unavailability of rapid tests leads to preventable complications from mismanagement of DI. There is therefore a substantial unmet need for in-home sodium monitoring in the target pediatric DI population as well as an exciting potential of a sodium monitor specifically designed and approved for in-home use. Currently available blood electrolyte analyzers are expensive laboratory instruments, accept venous blood at volumes much higher than fingersticks, and are not practical for routine in home testing for blood sodium. The overall goal of this program is to develop an in-home, cost-effective sensor product that accurately measures blood sodium. A rapid and simple electrochemical test to quantify the blood levels of sodium meets a critical need within DI care. Giner will develop a handheld blood sodium monitor and demonstrate quantitative detection of sodium using small volume fingerstick blood volumes (< 100 µl), within a broad linear range of 100-360 mM (normal range is 138-146 mM). Giner will utilize a modified ion-selective electrode (ISE) approach that will allow for rapid (single-step), label-free, and reagent-free operation similar to a blood glucose test. The Aims of the Phase I feasibility program are: 1) Development of a sodium test strip modified with sodium ion selective membrane (ISM) formulations; 2) Development of sample handling techniques and sensor calibration for point-of-care operation; and 3) Adapting sensor for blood analysis, testing with blood plasma samples, and benchmarking performance against the standard clinical chemistry methodologies.