Point-of-Care Blood Ammonia Measurement Using a Gas-Phase Fuel Cell Sensor

项目摘要：从手指或脚跟针刺测量血氨 目标是开发一种便携式设备，测量血液中的氨水平， 或者脚后跟贴，就像糖尿病患者测量血糖水平一样。PAD将立即诊断 血氨升高（高氨血症），从而触发治疗，并防止氨诱导的 脑损伤PAD将允许手指和脚跟穿刺，使儿童免受静脉穿刺的创伤， 仅需0.02 ml（20 µL）的血量，可保存婴儿的血液。 相比之下，标准的临床实验室测试需要：接近中心实验室（通常在 医院）和1至2小时的周转时间;由受过训练的抽血师进行静脉插管;以及 至少3 ml的血液，或比PAD多300倍的血液。 PAD可能对儿童健康产生重大影响。快速诊断和密切监测血液 氨将指导治疗，从紧急血液透析，静脉注射氨清除剂， 家庭用药在美国，高氨血症对儿童和成人人群都有风险：（一） 20，000名儿童在44个基因中的任何一个发生突变;（2）每年有400，000名早产儿在37岁之前出生 （3）630，000名患有肝硬化的成年人;（4）140，000名接受5- 氟尿嘧啶化疗;（5）600万肥胖相关非酒精性脂肪性肝炎成人 （NASH）。 PAD采用了一种新技术，它采用了一种价格低廉（190美元）的商用燃料电池 使用含K2 CO 3的消耗性药筒释放的用于血液的气态氨检测器 样品中的气态氨。PAD的快速诊断将保护许多儿童的脑功能。 当PAD被部署到床边和门诊诊所时，治疗将得到改善。 目标1.创建并验证能够生产适用于以下产品的检测盒的检测盒生产系统 临床研究 我们的具体目标是开发一种内部墨盒生产和组装工艺， 生产批量> 5，000个测试卡片，显示K2 CO 3负载的变化小于15%，并提供 氨定量限≤20 µM。 1

Project Summary: Measurement of blood ammonia from a finger or heel stick The goal is to develop a portable device that measures ammonia levels in blood obtained by finger or heel stick, in the same way that diabetics measure their blood sugar levels. PAD will instantly diagnose elevated blood ammonia (hyperammonemia), thus triggering treatment, and preventing ammonia-induced brain damage. PAD will permit finger and heel sticks, sparing children the trauma of venipuncture, and requires only 0.02 ml (20 µL) blood volumes, conserving the blood of tiny infants. By contrast, the standard clinical laboratory test requires: proximity to a central laboratory (usually in a hospital) and 1 to 2 hours of turn-around time; intravenous cannulation by a trained phlebotomist; and at least 3 ml of blood, or 300-fold more blood than PAD. PAD can have a major impact on child health. Rapid diagnosis and close monitoring of blood ammonia will guide treatments, from emergency hemodialysis, to intravenous ammonia scavengers, to home medications. Hyperammonemia presents a risk to both child and adult populations in the U.S.: (1) 20,000 children with mutations in any one of 44 genes; (2) 400,000 preterm infants born annually before 37 weeks with immature livers; (3) 630,000 adults with liver cirrhosis; (4) 140,000 cancer patients receiving 5- fluorouracil chemotherapy; and (5) 6 million adults with obesity-associated nonalcoholic steatohepatitis (NASH). PAD uses a novel technology that adapts an inexpensive ($190) commercially available fuel cell gaseous ammonia detector for use with blood using a consumable cartridge containing K2CO3 to liberate gaseous ammonia from the sample. Rapid diagnosis by PAD will protect brain function in many children. Treatment will improve when PAD is deployed to the bedside and outpatient clinics. Aim 1. Create and validate a cartridge production system capable of producing cartridges suitable for clinical studies Our specific aim is to develop an in-house cartridge production and assembly process that can produce lot sizes of >5,000 cartridges that show less than 15% variability in K2CO3 loading and provide an ammonia limit of quantification of ≤20 µM. 1