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: 7683148
• 负责人: Dale M Willard
• 金额: $ 38.2万
• 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 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7683148
• 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; Congenital Abnormality; Cost of Illness; 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; Patients; Pharmaceutical Preparations; Phase; Physicians; Plasma; Pregnancy Complications; Procedures; Proteins; Pump; Reducing Agents; Risk Factors; Sampling; Shipping; Ships; 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; flexibility; folic acid metabolism; improved; instrument; instrumentation; microchip; modifiable risk; novel marker; point of care; prototype; public health relevance; rapid detection; 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）是美国和西方世界的大部分杀手。该疾病的治疗每年要花费数十亿美元，费用继续呈指数增长。如果将CVD之外的单独状况视为单独的状况，则中风是心脏病和癌症背后的第三大死亡原因。总同型半胱氨酸（THCY）是CVD的确认独立危险因素。此外，它是叶酸和结肠蛋白（维生素B12）缺乏症的敏感标志物，对老年人的出生缺陷，妊娠并发症，精神疾病和认知障碍产生影响。每年在美国与这些条件相关的每年进行几百万个THCY测试。 THCY已引起了CVD的可修改风险因素的大幅关注，因为仅通过饮食中补充叶酸和维生素B12就可以降低水平。尽管以这种方式的价值仍然未经证实，但与中风特别相关的有力证据持续了。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，用于服用已知降解叶酸代谢的药物的患者。还提出了一个额外的标记，即降低的同型半胱氨酸（Rehcy），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进行。 Advanced Microlabs，LLC正在开发微流体技术，用于快速检测疾病生物标志物，这些疾病生物标志物将是便宜的（500美元的乐器，3美元/分析），需要很小的样品（即手指刺而不是抽血），在几分钟之内提供结果，不需要像现在这样的样品预处理，例如现在是换离心的样品。在当前的项目中，我们将基于成功的I阶段结果，并创建一个通用的护理设备，以检测THCY和REHCY。此外，由于我们的设备是一个多分析师平台，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市场在2005年成为100亿美元的行业，目前的增长速度比中央实验室测试更快。这是因为像我们这样的设备提供了更便宜的测试，更接近患者，降低医疗保健成本以及增强医师患者对话框，从而改善了护理。