Electrochemical Home Monitoring System for Lithium Blood Level

碳酸锂形式的锂是双相情感障碍（BD）和其他疾病的重要药物治疗选择。然而，锂的治疗范围很窄，使用锂需要仔细监测患者血液中的锂含量，特别是在治疗开始时。目前的监测技术既不方便又昂贵，需要一个临床分析实验室。目前还没有商用的家庭血锂测量系统。该计划的目标是开发一种基于电化学的检测方法，包装成便携式，独立的，易于使用的仪器/系统，用于分析锂。它适合在家庭环境中监测BD患者或其他使用锂治疗的患者的锂水平。它也可以用于临床医生的办公室，在办公室访问期间进行实时读数。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，以便在家中自动操作，与其他基于实验室的分析技术相比，这使得它们非常便宜和方便。最终的家用锂监测产品将具有与家用血糖监测仪相同的易用性，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。该仪器可在患者手指刺血后几分钟内可靠、准确地测定锂离子浓度，并将结果实时报告给临床医生。频繁的家庭监测既可以用来调节剂量，也可以用来确认病人是否在服用处方药。这将改善病人护理并降低医疗费用。在第一阶段，Giner公司开发了传感器设计配置，采用高性能电极材料和操作条件，证明了在水介质（包括生理液体兴奋剂）中电化学检测相关范围（0.2-3 mM）锂离子（Li+）的可行性。在钠离子和钾离子的生理浓度存在下测量锂离子浓度的能力得到了证明，这是所提出的电分析技术成功的关键。在水系统中直接测量的能力是一项极有价值的第一阶段发现，因为它使血液中锂的检测尽可能简单。第二阶段的具体目标包括检测方法的优化，微分析系统的开发，集成仪器的设计和制造，以及与马萨诸塞州总医院双相情感障碍诊所和研究项目合作的实验室样品评估。

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 (BD) 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. The goal of this program is the development of an electrochemically-based detection method packaged into a portable, self-contained, easy-to-use instrument/system for the analysis of lithium. It will be appropriate for use in a home setting for the monitoring of lithium level for BD patients or other patients utilizing lithium treatment. It could also be used in the clinician's office for real-time readings during office visits. 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 home lithium monitor product will have the same 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. This instrument will reliably and accurately determine the lithium concentration within several minutes after the patient supplies a blood sample by finger prick and the results will be reported in real time to the clinician. Frequent home monitoring could be used both to regulate dosage and to confirm patient is taking the prescribed medication. This will improve patient care as well as decrease medical costs. During Phase I, Giner, Inc. developed sensor design configurations, with high performance electrode material, and operating conditions which demonstrated feasibility of electrochemical detection of the relevant range (0.2-3 mM) of lithium ion (Li+) in an aqueous medium, including a physiological fluid stimulant. The ability to measure lithium ion concentration in the presence of physiological concentrations of sodium and potassium ions was demonstrated and is key to the success of the proposed electroanalytical technique. The ability to measure directly in an aqueous system is an extremely valuable Phase l finding, as it keeps the detection of lithium in blood as simple as possible. The Phase II Specific Aims encompass optimization of the detection method, development of the microanalysis system, design and fabrication of an integrated Instrument, and laboratory sample evaluation in collaboration with The Massachusetts General Hospital Bipolar Clinic and Research Program. 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.