Electrochemical Home Monitoring System for Lithium Blood Level

家用电化学锂血浓度监测系统

基本信息

批准号：
8838511
负责人：
LINDA A TEMPELMAN
金额：
$ 60.65万
依托单位：
GINER, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-04-01 至 2017-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8838511
关键词：
AA Spectrophotometry Adoption Adult Adverse effects Affect Bipolar Disorder Blinded Blood Blood Chemical Analysis Blood Tests Blood specimen Boston Calibration Caregivers Chronic Clinic Clinical Clinical Research Collaborations Communication Comparative Study Consultations Data Decision Making Detection Development Development Plans Devices Diagnostic Disadvantaged Dose Drops Drug Prescriptions Electrodes Electronics Engineering Film Fingers General Hospitals Goals Health Care Costs Home environment Hospitalization Hospitals In Vitro Ions Laboratories Lead Life Lithium Lithium Carbonate Maintenance Manic Manic Disorder Marketing Massachusetts Measurement Measures Medical Mental Health Methods Modeling Modification Monitor Overdose Oxidation-Reduction Patients Peer Review Pharmacologic Substance Pharmacotherapy Phase Physicians&apos Offices Physiological Play Point-of-Care Systems Preparation Price Process Product Approvals Quality of life Readiness Reagent Recording of previous events Reporting Reproducibility Research Ruthenium Sampling Scheme Serum Site Small Business Innovation Research Grant Sodium System Techniques Technology Testing Therapeutic Thick Time Toxic effect Translating Treatment outcome Urine base blood product clinical research site cost design effective therapy glucose monitor improved instrumentation interest journal article meetings novel point of care product development programs prototype public health relevance research clinical testing sensor success user-friendly

项目摘要

DESCRIPTION (provided by applicant): Electrochemical Home Monitoring System for Lithium Blood Level Over the past 50 years, pharmaceutical lithium has been one of the most widely-used and prescribed drugs for the effective treatment of bipolar disorder and other manic disorders. Despite the long history of use and efficacy, controlling patient blood levels in the narrow therapeutic range (~0.6 - 1.2mm/L Li+) still remains a challenge. A dose below this range may be ineffective, and a dose above this range may cause serious side effects of lithium toxicity. Currently, a fast, accurate, and inexpensive point-of-care method for detecting lithium blood levels does not exist. Available methods for detecting lithium in blood all require expensive and bulky analytical instrumentation, such as atomic absorption spectrophotometry or blood chemistry analyzer systems. The time delays and high cost of sending patients or blood samples to off-site clinical analytical laboratories remains a significant impediment to effective lithium treatment, particularly with respect to the frequent monitoring required during the onset of treatment and for desired compliance monitoring. Suboptimal treatment of bipolar disorder can lead to traumatic and costly hospitalizations. Therefore, Giner proposes to offer the first commercially-available, handheld lithium monitor for rapid and inexpensive blood lithium analysis for point-of-care use, at home or in a clinician's office. During Phase II, Giner successfully designed and fabricated a tabletop prototype lithium monitor utilizing a new, patentable electroanalytical technique and low-cost disposable sensing chips for accurately detecting lithium in patient serum samples and in blood samples. During Phase IIB, Giner will further develop the lithium monitor into a commercial product that incorporates plug-and-play disposable cartridges into a handheld device performing the electroanalytical technique, and displaying the lithium blood concentration to the user. The Giner Point-of-Care Lithium Monitor will also offer an automated calibration scheme, an automated device maintenance check, and remote communication of patient data to the clinician's office. Phase IIB concludes with a comparative study with clinical blood samples from a finger prick to provide equivalency data for a 510(k) filing for the first product model.

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在过去的 50 年里，药用锂已成为有效治疗双相情感障碍和其他躁狂症的最广泛使用和处方药物之一。尽管使用历史悠久且疗效显着，但将患者血液水平控制在狭窄的治疗范围（~0.6 - 1.2mm/L Li+）仍然是一个挑战。低于此范围的剂量可能无效，高于此范围的剂量可能会导致锂中毒的严重副作用。目前，尚不存在一种快速、准确且廉价的检测血液锂水平的即时检测方法。检测血液中锂的现有方法都需要昂贵且笨重的分析仪器，例如原子吸收分光光度法或血液化学分析仪系统。将患者或血液样本送往异地临床分析实验室的时间延误和高昂成本仍然是有效锂治疗的重大障碍，特别是在治疗开始期间所需的频繁监测和所需的依从性监测方面。双相情感障碍的次优治疗可能会导致创伤性的和昂贵的住院治疗。因此，Giner 提议提供首款市售手持式锂监测仪，用于在家中或临床医生办公室进行即时护理使用的快速且廉价的血锂分析。在第二阶段，Giner 成功设计并制造了一款桌面原型锂监测仪，利用新型可专利电分析技术和低成本一次性传感芯片来准确检测患者血清样本和血液样本中的锂。在IIB阶段，Giner将进一步将锂监测器开发成商业产品，将即插即用的一次性墨盒整合到执行电分析技术的手持设备中，并向用户显示锂血液浓度。 Giner 护理点锂监视器还将提供自动校准方案、自动设备维护检查以及将患者数据远程通信到临床医生办公室。 IIB 期最后进行了一项与采自手指采血的临床血样的比较研究，为第一个产品型号的 510(k) 备案提供等效数据。