Rapid, Inexpensive Microchip Assay for Homocysteine

快速、廉价的同型半胱氨酸微芯片测定

• 批准号: 7538309
• 负责人: Dale M Willard
• 金额: $ 36.8万
• 依托单位: ADVANCED MICROLABS, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7538309
• 关键词: Accounting; Acute; Attention; Biological Assay; Biological Markers; Blood; Blood specimen; Cardiovascular Diseases; Caring; Cause of Death; Centrifugation; Cessation of life; Clinic; Clinical; Clinical Trials; Condition; Congenital Abnormality; Cost of Illness; Cytarabine/Etoposide/Mitoxantrone; Detection; Device Designs; Devices; Dietary Supplementation; Disease; Elderly; Facilities and Administrative Costs; Fingers; Folate; Folic Acid; Health Care Costs; Healthcare; Heart Diseases; Homocysteine; Homocystine; Impaired cognition; Industry; Ischemic Stroke; Laboratories; Liquid substance; Malignant Neoplasms; Marketing; Mental disorders; Methods; Microfluidics; Minor; Monitor; Numbers; Patients; Pharmaceutical Preparations; Phase; Physicians; Plasma; Pliability; Pregnancy Complications; Procedures; Proteins; Public Health; Pump; Rate; Reducing Agents; Risk Factors; Sampling; Shipping; Ships; Standards of Weights and Measures; Stroke; System; Technology; Testing; Time; Treatment Step; United States; Vitamin B 12; Vitamin B 12 Deficiency; Vitamin Deficiency; Western World; Whole Blood; Work; cost; design; folic acid metabolism; improved; instrument; instrumentation; microchip; modifiable risk; point of care; prototype; rapid detection; size; tool; user-friendly

DESCRIPTION (provided by applicant): Cardiovascular disease (CVD) is the number 1 killer in the United States and much of the Western world. Treatment of the disease costs billions of dollars each year and the costs continue to rise exponentially. If considered as a separate condition outside of CVD, stroke is the 3rd leading cause of death behind heart disease and cancer. Total Homocysteine (tHCY) is a confirmed independent risk factor for CVD. Additionally, it is a sensitive marker for folate and colalamin (vitamin B12) deficiency, with implications to birth defects, pregnancy complications, psychiatric disorders, and cognitive impairment in the elderly. Several million tHCY tests are performed annually in the U.S. related to these conditions. tHCY has garnered significant attention as a modifiable risk factor for CVD because levels can be reduced simply through dietary supplementation of Folic Acid and Vitamin B12. While tHCY's value in this manner still remains unconfirmed, strong evidence is mounting in its association specifically with stroke. At the same time, tHCY is finding a growing market as a vitamin deficiency monitoring tool for patients taking drugs known to degrade folate metabolism. An additional marker, Reduced Homocysteine (reHCY), has also been proposed as an alternative to tHCY. Currently, tHCY and reHCY analysis requires expensive instrumentation, time consuming procedures, and can only be performed in a clinical laboratory. Advanced Microlabs, LLC is developing microfluidic technology for rapid detection of disease biomarkers that will be inexpensive ($500 instrument, $3/assay), require very small samples (i.e., finger prick instead of a blood draw), provide results within minutes, and require no sample pretreatment such as centrifugation as is now currently the case. In the current project, we will build on our successful Phase I results and create a versatile point-of-care device for the detection of tHCY and reHCY. Additionally because our device is a multi-analyte platform, other relevant markers could be added to our menu in Phase III. PUBLIC HEALTH RELEVANCE: The U.S. POC market became a $10 billion industry in 2005 and is currently growing at a faster rate than central laboratory testing. This is because devices like ours offer cheaper testing, closer to the patient, reduction in healthcare costs, and enhancements the physician-patient dialog and thus improving care.

描述（由申请人提供）：心血管疾病（CVD）是美国和西方世界大部分地区的第一号杀手。该疾病的治疗每年花费数十亿美元，并且费用继续呈指数级增长。如果将中风视为心血管疾病之外的一种独立疾病，那么中风是仅次于心脏病和癌症的第三大死因。总同型半胱氨酸（tHCY）是已证实的 CVD 独立危险因素。此外，它还是叶酸和胶原蛋白（维生素 B12）缺乏的敏感标志物，与出生缺陷、妊娠并发症、精神疾病和老年人认知障碍有关。美国每年都会进行数百万次与这些情况相关的 tHCY 测试。 tHCY 作为 CVD 的可改变危险因素而受到广泛关注，因为只需通过膳食补充叶酸和维生素 B12 即可降低其水平。虽然 tHCY 的这种价值尚未得到证实，但越来越多的有力证据表明它与中风的关系。与此同时，tHCY 正在寻找一个不断增长的市场，作为一种维生素缺乏监测工具，适用于服用已知会降低叶酸代谢的药物的患者。另一种标记物，还原同型半胱氨酸 (reHCY)，也被提议作为 tHCY 的替代品。目前，tHCY 和 reHCY 分析需要昂贵的仪器、耗时的程序，并且只能在临床实验室中进行。 Advanced Microlabs, LLC 正在开发用于快速检测疾病生物标志物的微流体技术，该技术价格低廉（仪器 500 美元，每次检测 3 美元），需要非常小的样本（即刺破手指而不是抽血），在几分钟内提供结果，并且不需要像现在这样的离心等样本预处理。在当前项目中，我们将在第一阶段成功结果的基础上，创建一种用于检测 tHCY 和 reHCY 的多功能护理点设备。此外，由于我们的设备是多分析物平台，因此可以将其他相关标记添加到第三阶段的菜单中。 公共卫生相关性：美国 POC 市场于 2005 年成为一个价值 100 亿美元的产业，目前的增长速度比中心实验室测试还要快。这是因为像我们这样的设备可以提供更便宜的测试，更接近患者，降低医疗成本，并增强医患对话，从而改善护理。