Test Strip for Point-Of-Care Monitoring of Serum/Whole Blood Lithium Levels

用于即时监测血清/全血锂水平的测试条

• 批准号: 7537622
• 负责人: Wai Tak Law
• 金额: $ 11.93万
• 依托单位: PORTASCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7537622
• 关键词: American; Bedside Testings; Bipolar Disorder; Blood; Blood specimen; Brain Diseases; Cellulose; Characteristics; Chemistry; Chronic; Clinical; Condition; Development; Drug Prescriptions; Dyes; Enzymes; Expressed Sequence Tags; Fingers; Glucose; Goals; Hand; Laboratories; Liquid substance; Lithium; Measurement; Membrane; Methods; Monitor; Moods; Nylons; Patients; Persons; Phase; Physicians; Polymers; Public Health; Quality of life; Range; Reading; Reagent; Refrigeration; Renal function; Running; Sampling; Serum; Solid; System; Temperature; Testing; Therapeutic; Time; Toxic effect; Venipunctures; Whole Blood; Work; design; digital; improved; meter; performance tests; point of care; prevent; reconstitution; solid state; surfactant; treatment planning

DESCRIPTION (provided by applicant): The long-term objective of this proposal is the development of an inexpensive, simple-to-use, point-of-care test for the quantitative determination of whole blood lithium concentration from a finger-stick sample. Lithium is used to treat bipolar disorder, also known as manic-depressive illness. Bipolar disorder is a chronic brain disorder that causes unusual shifts in a person's mood, energy, and ability to function. Approximately 5.7 million Americans suffer from the condition. Lithium is the most commonly used agent for treating bipolar disorder. Lithium monitoring is essential due to the narrow therapeutic range of serum lithium (0.5 to 1.5 mM); and to the potential toxicity from intercurrent illness, declining renal function, or co-prescription of drugs. Current tests most often require a venipuncture blood sample that is sent to a laboratory for testing. The proposed project aims to design a test strip, similar to those used for glucose testing, that can be run by the physician using a finger-stick blood sample obtained from their patient. Obtaining a result, while still with the patient, will allow the physician to modify the treatment plan if necessary. The proposed final product will consist of a test strip containing dried reagents (solid phase format) and a hand-held digital meter. The user will insert the test strip into the meter, apply whole blood using a finger-stick sample, wait a fixed time, and then read the lithium concentration from the meter. The goal of the Phase I proposal is to determine the feasibility of transferring existing liquid format lithium test chemistry - used in laboratory testing -to a solid state, test strip format. Initial development work will use lithium spiked serum samples. Use of lithium spiked whole blood or clinical samples will be added in the Phase II design. Phase I has five aims. Aim 1 is to identify a single or binary dye substrate system with serum lithium sensitivity of 0.3 to 3.0 mM that can be used in a solid phase format. In addition to final sensitivity, other characteristics of the dye substrate system will be considered, such as molar absorptivity and stability. Aim 2 will focus on identifying membrane materials, additives, and stabilizers. Some examples of components to be evaluated are: cellulose and nylon for membrane support materials; surfactants as additives to aid in reagent reconstitution once sample is applied; and polymers/co-polymers as stabilizers to protect the dried reagents (enzymes, dye substrate). Aim 3 will evaluate for correlation and precision. Test strips will be run with lithium spiked serum. The same serum will be sent to a lab for testing. The results of the two systems will be used to compute correlation. Precision will be determined at three lithium concentrations. Aim 4 will start evaluating the stability of the test strips when stored with refrigeration. Aim 5 is to refine design for Phase II submission. Phase II will continue the project with the following aims already having been defined: (1) add a blood separation system to the test strip to allow for finger-stick samples; (2) couple the test strip with a hand-held digital meter to obtain quantitative results; and (3) investigate methods to allow for room temperature storage PUBLIC HEALTH RELEVANCE The proposed test strip for lithium will allow a physician to determine serum lithium concentration while still with a patient. Having a result, without sending out to a lab, means the physician can more easily manage a patient's therapeutic range. This can help improve the patient's quality of life and help prevent lithium toxicity.

描述（由申请人提供）：本提案的长期目标是开发一种廉价、易于使用的即时检测方法，用于定量测定手指针刺样本中的全血锂浓度。锂被用来治疗双相情感障碍，也被称为躁狂抑郁症。双相情感障碍是一种慢性脑部疾病，会导致一个人的情绪、能量和功能发生不寻常的变化。大约有570万美国人患有这种疾病。锂是治疗双相情感障碍最常用的药物。由于血清锂的治疗范围较窄（0.5至1.5 mM），以及并发疾病、肾功能下降或联合处方药物的潜在毒性，锂监测至关重要。目前的测试通常需要将静脉穿刺血样送到实验室进行测试。拟议的项目旨在设计一种测试条，类似于用于葡萄糖测试的测试条，可以由医生使用从患者身上获得的手指针刺血样运行。在患者仍在的情况下获得结果将允许医生在必要时修改治疗计划。拟定的最终产品将包括含有干燥试剂（固相格式）的试纸和手持式数字仪表。用户将测试条插入血糖仪，使用手指针刺样本应用全血，等待固定时间，然后从血糖仪读取锂浓度。第一阶段提案的目标是确定将实验室测试中使用的现有液体形式锂测试化学品转换为固态测试条形式的可行性。初始开发工作将使用锂加标血清样本。将添加锂加标全血或临床样本的使用 第二阶段设计。第一阶段有五个目标。目的1是鉴定可以以固相形式使用的血清锂灵敏度为0.3至3.0 mM的单一或二元染料底物系统。除最终灵敏度外，还将考虑染料底物系统的其他特性，如摩尔吸光系数和稳定性。目标2将侧重于识别膜材料，添加剂和稳定剂。待评价组分的一些示例为：用于膜支撑材料的纤维素和尼龙;用作添加剂的表面活性剂，以在样品应用后帮助试剂复溶;以及用作稳定剂的聚合物/共聚物，以保护干燥的试剂（酶、染料底物）。目标3将评价相关性和精密度。将使用锂加标血清运行试纸。同样的血清将被送到实验室进行测试。两个系统的结果将用于计算相关性。将在三种锂浓度下测定精密度。目标4将开始评价试纸冷藏储存时的稳定性。目标5是完善第二阶段申报的设计。第二阶段将继续该项目，并已确定了以下目标：（1）在试纸条上增加血液分离系统，以允许手指针刺样本;（2）将试纸条与手持式数字仪表结合，以获得定量结果;以及（3）研究允许室温储存的方法公共卫生相关性所提出的锂测试条将允许医生确定血清锂浓度而仍然与病人。有一个结果，而不发送到实验室，意味着医生可以更容易地管理病人的治疗范围。这可以帮助改善患者的生活质量，并有助于防止锂中毒。