Electrochemical Home Monitoring System for Lithium Blood Level

在过去的50年里，药物锂一直是最广泛使用和处方的药物之一，用于有效治疗双相情感障碍和其他躁狂障碍。尽管具有悠久的使用历史和疗效，但将患者血药浓度控制在狭窄的治疗范围内（~0.6 - 1.2mm/L Li+）仍然是一个挑战。低于这个范围的剂量可能是无效的，超过这个范围的剂量可能会引起锂中毒的严重副作用。目前，还不存在一种快速、准确、廉价的即时检测血液中锂含量的方法。现有的检测血液中锂的方法都需要昂贵而笨重的分析仪器，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到非现场临床分析实验室的时间延迟和高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需要频繁监测和期望的依从性监测方面。双相情感障碍的次优治疗可能导致创伤性和昂贵的住院治疗。因此，Giner建议提供第一个商用的手持式锂监测仪，用于快速和廉价的血锂分析，用于家庭或临床医生办公室。在第二阶段，Giner成功地设计和制造了一个桌面原型锂监测仪，利用一种新的、可申请专利的电分析技术和低成本的一次性传感芯片，用于准确检测患者血清样本和血液样本中的锂。在IIB阶段，Giner将进一步将锂监测仪开发成商业产品，将即插即用的一次性药盒集成到执行电分析技术的手持设备中，并向用户显示锂血浓度。Giner Point-of-Care锂离子监测仪还将提供自动校准方案、自动设备维护检查以及患者数据与临床医生办公室的远程通信。IIB期以手指穿刺的临床血液样本的比较研究结束，为第一个产品模型的510(k)申请提供等效数据。

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.