Development of Stroke Point of Care Immunoassay for Cellular Fibronectin

细胞纤连蛋白中风护理点免疫测定的开发

基本信息

批准号：
7941816
负责人：
Albert K Man
金额：
$ 60.2万
依托单位：
PREDICTION SCIENCES, LLC
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-04-01 至 2011-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7941816
关键词：
Accounting Acute Admission activity Adverse effects Affect Affinity Aging Alteplase American Antibodies Antigens Arteries Back Binding Biological Assay Biological Preservation Blood Brain Cause of Death Cerebral Thrombosis Cerebral hemisphere hemorrhage Cerebrum Cessation of life Characteristics Clinical Coagulation Process Development Diagnostic Diagnostic tests Direct Costs Enzymes Evaluation Event FDA approved Facilities and Administrative Costs Fibronectins Fright Goals Gold Colloid Healthcare Hemorrhage Hour Human Immunoassay Incidence Intravenous Ischemic Stroke Lateral Lead Link Literature Manufacturer Name Marketing Measures Membrane Methods Outcome Patients Peptides Performance Phase Physicians Plasma Plasma Cells Population Procedures Production Proteins Proteomics Protocols documentation Reader Reading Reagent Recombinant Antibody Recovery Reference Standards Reperfusion Therapy Reproducibility Research Risk Sampling Sensitivity and Specificity Signal Transduction Small Business Innovation Research Grant Stroke Symptoms Technology Testing Thromboembolism Thrombolytic Therapy Time United States Venous Work Writing acute stroke antibody conjugate base brain tissue clinical practice cost design disability evaluation/testing high risk improved molecular marker particle patient safety point of care point-of-care diagnostics prevent prototype public health relevance research study risk benefit ratio stem thrombolysis

项目摘要

DESCRIPTION (provided by applicant): Stroke is the leading cause of disability and the third leading cause of death in the U.S., with an estimated $60 billion negative impact upon the economy in indirect and direct costs in 2006. Immediate treatment of stroke is critical for preservation brain tissue and ultimate recovery. For ischemic stroke, which comprises approximately four-fifths of all strokes, thrombolytic therapy by tissue plasminogen activator (tPA) has been proven to be effective in the critical first 3 hours from symptom onset. Unfortunately, studies have shown symptomatic hemorrhagic occurs in 6-11% of patients treated with intravenous tPA. Fear of this severe and often deadly side effect prevents the widespread use and full benefit of this therapy in the ischemic stroke population. This SBIR Phase II application proposes the development of a point-of-care rapid diagnostic test for the proteomic marker cellular fibronectin (c-Fn), which has been shown in 3 independent studies to predict hemorrhagic transformation in tPA-treated patients with a sensitivity of 100%, as an aid to treatment decision. The goal under this proposal is to create a rapid test for c-Fn based on lateral flow technology with the ability to obtain a result within 10 minutes, achieve inter- and intra-assay variability of <10%, and achieve a total production cost of under $25. PUBLIC HEALTH RELEVANCE: Project Narrative Physicians must decide on treatment of an ischemic stroke patient with a clot buster, tPA, within a critical 3 hour time window. The amount of cellular fibronectin (c-Fn) in the blood of patients at admission can identify if the patient is at high or low risk for a subsequent hemorrhage, fear of which prevents widespread useage of tPA. This proposal develops a rapid c-Fn test completed in 10 minutes to aid in the treatment decision of acute ischemic stroke patients that would lead to increase in patient safety, decrease in the long-term disability of stroke, and lower long-term healthcare spending.

描述（由申请人提供）：中风是美国残疾的主要原因，也是美国第三大死亡原因，估计对2006年间接和直接成本的经济产生了600亿美元的负面影响。中风立即治疗对于保存脑组织和最终恢复至关重要。对于包括所有中风的大约五分之一的缺血性卒中，已证明，通过组织纤溶酶原激活剂（TPA）溶栓治疗（TPA）在症状发作的关键前3个小时内有效。不幸的是，研究表明，有6-11％的静脉内TPA患者发生症状出血性。对这种严重且经常致命的副作用的恐惧阻止了这种疗法在缺血性中风人群中的广泛使用和全部利益。该SBIR II期应用提出了针对蛋白质组学标记细胞纤连蛋白（C-FN）的即时护理快速诊断测试的开发，该测试已在3项独立研究中表明，以预测TPA治疗的患者的出血转化，其敏感性为100％，作为治疗决策的帮助。该提案下的目标是基于横向流量技术为C-FN创建快速测试，并能够在10分钟内获得结果，实现<10％的测定和内部内变异性，并达到25美元以下的总生产成本。公共卫生相关性：项目叙事医师必须在3个小时的关键时间内确定与Clot Buster TPA的缺血性中风患者的治疗。入院时患者血液中细胞纤连蛋白（C-FN）的量可以确定患者是否患有后续出血的风险很高或低风险，担心会阻止TPA的广泛使用。该建议在10分钟内完成了快速的C-FN测试，以帮助急性缺血性中风患者的治疗决定，这将导致患者安全性提高，中风长期残疾的减少以及长期的长期医疗保健支出。