Electrochemical Home Monitoring System for Lithium Blood Level

描述（由申请人提供）： 锂的电化学家庭监测系统血液水平碳酸锂形式的锂是双相情感障碍和其他疾病的重要药物治疗选择。然而，锂具有狭窄的治疗范围，并且其使用需要仔细监测患者的锂血液水平，特别是在治疗开始期间。目前的监测技术既不方便又昂贵，需要临床分析实验室。目前还没有市售的系统用于家庭测量血锂。该计划将开发一种先进，快速，方便的家庭系统，可以对那些接受锂治疗的人的健康产生重大影响，并鼓励在医疗条件下充分使用锂。在拟议的工作中的创新是开发一种电化学传感器，包括一个高性能的微电极结合一个敏感的和选择性的电分析技术，在一个主要的非水电化学环境中测量锂浓度在临床上重要的范围（0.2 - 3.0毫摩尔每升）从（水性）血液样品。Giner公司将扩大其关于锂检测的初步数据，并利用其在拟议的电化学技术和电极材料方面的经验。所提出的技术的一个主要优点是，电化学技术可以封装到仪器中，用于在家中自动操作，这使得它们与其他基于实验室的分析技术相比非常便宜和方便。最终产品将具有家用葡萄糖监测仪的易用性，并为临床医生提供最佳和具有成本效益的患者治疗所需的实时锂测量。虽然双相情感障碍有多种药物治疗，但美国570万确诊患者中约有20%使用锂作为治疗的一部分。申报产品可由患者在家中使用，也可由临床医生在门诊访视期间使用。 公共卫生相关性： SBIR研究和开发计划的总体目标是开发一种基于家庭的血锂监测系统，供患者使用。血液中的锂水平非常关键;因此，双相情感障碍患者现在需要频繁进行实验室血液检查。一个以家庭为基础的系统将为病人提供方便，同时改善治疗和降低医疗费用。

DESCRIPTION (provided by applicant): Electrochemical Home Monitoring System for Lithium Blood Level Lithium in the form of lithium carbonate is an important pharmacological treatment option in bipolar disorder and other conditions. However, lithium has a narrow therapeutic treatment range and its use requires careful monitoring of a patient's lithium blood level, particularly during the initiation of treatment. Current monitoring techniques are inconvenient and costly, requiring a clinical analytical laboratory. There is no commercially- available system for home measurement of blood lithium. This program will develop an advanced, rapid, and convenient home system which could make a significant impact in the health of those individuals being treated with lithium and encourage full therapeutic use of lithium when the medical condition merits. The innovation in the proposed work is to develop an electrochemical sensor comprised of a high performance microelectrode combined with a sensitive and selective electroanalytical technique in a predominantly nonaqueous electrochemical environment to measure lithium concentration in the clinically important range (0.2 - 3.0 millimoles per liter) from (aqueous) blood samples. Giner, Inc. will expand on its preliminary data on lithium detection and utilize its experience with the proposed electrochemical techniques and electrode materials. A major advantage of the proposed technology is that electrochemical techniques can be packaged into instruments for automated operation in the home which makes them very inexpensive and convenient compared to other laboratory-based analytical techniques. The final product will have the ease-of-use of a home glucose monitor and provide the clinician with real-time lithium measurements needed for optimal and cost-effective treatment of the patient. While there are multiple pharmacotherapy treatments for bipolar disorder, approximately 20% of the 5.7 million diagnosed patients in the U.S. use lithium as part of their treatment. The proposed product could be used in the home by the patient and also by the clinician during office visits. PUBLIC HEALTH RELEVANCE: The overall goal of this SBIR research and development program is the development of a home-based monitoring system for blood lithium for patient's use. The lithium blood level is very critical; therefore, bipolar disorder patients are now required to have frequent laboratory blood tests. A home-based system would provide convenience for patients while improving treatment and decreasing health care costs.