Electrochemical Home Monitoring System for Lithium Blood Level

家用电化学锂血浓度监测系统

• 批准号: 8252912
• 负责人: LINDA A TEMPELMAN
• 金额: $ 50.18万
• 依托单位: GINER, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8252912
• 关键词: Adult; Affect; Algorithms; Bipolar Disorder; Blinded; Blood; Blood Chemical Analysis; Blood Tests; Blood specimen; Boron; Caregivers; Cells; Characteristics; Chronic; Clinic; Clinical; Collaborations; Communication; Communities; Complex; Data; Data Analyses; Detection; Development; Diamond; Disadvantaged; Drops; Electrochemistry; Electrodes; Electronics; Ensure; Evaluation; Fingers; General Hospitals; Goals; Hand; Health Care Costs; Home environment; Human; Ions; Laboratories; Liquid substance; Lithium; Lithium Carbonate; Manic; Manic Disorder; Massachusetts; Measurement; Measures; Medical; Mental Health; Methods; Microelectrodes; Monitor; Office Visits; Patient Care; Patients; Performance; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Phase; Physicians; Physiologic pulse; Physiological; Plasma; Potassium; Process; Quality of life; Reading; Recording of previous events; Reporting; Research; Sampling; Sensitivity and Specificity; Serum; Simulate; Small Business Innovation Research Grant; Sodium; System; Systems Analysis; Techniques; Technology; Testing; Therapeutic; Time; Work; aqueous; base; catalyst; computerized data processing; cost; cost effective; design; dosage; effective therapy; glucose monitor; hospital laboratories; improved; innovation; instrument; instrumentation; medical specialties; meetings; method development; miniaturize; operation; potassium ion; programs; prototype; research and development; sensor; sodium ion; success; technology development; validation studies

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.

描述（由申请人提供）：用于锂血液水平的电化学家用监测系统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。目前还没有用于家庭测量血锂的市售系统。该计划的目标是开发一种基于电化学的检测方法，该方法被包装成便携式，独立式，易于使用的仪器/系统，用于锂的分析。它适用于家庭环境，用于监测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，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。最终的家用锂监测仪产品将具有与家用葡萄糖监测仪相同的易用性，并为临床医生提供患者最佳和具有成本效益的治疗所需的真实的实时锂测量。该仪器将在患者通过手指针刺提供血液样本后几分钟内可靠准确地测定锂浓度，并将结果真实的及时报告给临床医生。频繁的家庭监测可用于调节剂量并确认患者正在服用处方药物。这将改善患者护理并降低医疗成本。在第一阶段，Giner，Inc.开发的传感器设计配置，具有高性能电极材料，和操作条件，其证明电化学检测水性介质（包括生理流体刺激物）中锂离子（Li+）的相关范围（0.2 - 3mM）的可行性。证明了在生理浓度的钠离子和钾离子存在下测量锂离子浓度的能力，并且该能力是所提出的电分析技术成功的关键。在水溶液中直接测量的能力是一项非常有价值的I期发现，因为它使血液中锂的检测尽可能简单。II期特定目标包括优化检测方法、开发微量分析系统、设计和制造集成仪器以及与马萨诸塞州总医院双极临床和研究项目合作进行实验室样本评价。 公共卫生关系：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。