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

项目摘要：用手指或鞋跟棒测量血氨 他们的目标是开发一种便携式设备，通过手指测量血液中的氨含量 或脚跟贴，就像糖尿病患者测量他们的血糖水平一样。PAD将立即诊断 血氨升高(高氨血症)，从而触发治疗，防止氨诱导 脑部受损。PAD将允许手指和脚后跟粘在一起，避免了孩子们接受静脉穿刺术的创伤 只需要0.02毫升(20微米L)的血液容量，保存了小婴儿的血液。 相比之下，标准的临床实验室测试要求：靠近中心实验室(通常在 医院)和1至2个小时的周转时间；由训练有素的抽血师进行静脉插管；以及 至少3毫升的血液，或者说是PAD的300倍。 PAD会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，从紧急血液透析到静脉注射氨清除剂，以 家庭用药。高氨血症对美国儿童和成人都有风险：(1) 20,000名儿童44种基因中的任何一种发生突变；(2)每年有40万名早产儿在37岁之前出生 未成熟肝脏的数周；(3)630,000成人肝硬变；(4)140,000癌症患者接受5- 氟尿嘧啶化疗；和(5)600万肥胖相关的成人非酒精性脂肪性肝炎 (纳什)。 PAD使用了一项新技术，该技术采用了一种廉价(190美元)的商用燃料电池 用于血液的气态氨检测器，使用含有K2CO3的消耗盒以释放 样本中的气态氨。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合以下情况的墨盒的墨盒生产系统 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，该工艺可以 生产批量为&gt；5,000个碳粉盒，在K2CO3装载中显示出低于15%的变异性，并提供 ≤的氨限量为20µM。 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