Lab on a chip point of care assay for the rapid serodiagnosis of Lyme disease

用于莱姆病快速血清诊断的芯片即时检测实验室

• 批准号: 8195733
• 负责人: Maria Gomes-Solecki
• 金额: $ 30万
• 依托单位: BIOPEPTIDES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-03 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8195733
• 关键词: Adjustment Disorders; Affect; Antibodies; Antigens; Area; Biological Assay; Blood Volume; Borrelia burgdorferi; Caring; Centers for Disease Control and Prevention (U.S.); Clinic; DBL Oncoprotein; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Disease; Disease Outcome; Early Diagnosis; Early treatment; Ensure; Enzyme-Linked Immunosorbent Assay; Europe; FDA approved; Fingers; Goals; Health; Heart; Human; Immunological Diagnosis; Individual; Injury; Joints; Laboratories; Laboratory Diagnosis; Lupus; Lyme Disease; Manufacturer Name; Marketing; Microfluidics; Nervous system structure; Onset of illness; OspA protein; OspC protein; Performance; Phase; Physicians' Offices; Point-of-Care Systems; Proteins; Public Health; ROC Curve; Rheumatoid Arthritis; Running; Screening procedure; Sensitivity and Specificity; Serodiagnoses; Serum; Skin; Specificity; Staging; Symptoms; Syphilis; System; Technology; Testing; United States; Universities; Vector-transmitted infectious disease; Visit; base; body system; commercialization; cost; decorin binding protein B; design; improved; innovation; micro-total analysis system; novel; point of care; prevent; prototype

DESCRIPTION (provided by applicant): Caused by Borrelia burgdorferi, Lyme Disease (LD) can affect the skin, heart, joints or nervous system leading to an array of symptoms that overlap with those of other illnesses. LD is the most common vector-borne infectious disease in the United States and remains a significant public health concern. Early diagnosis and treatment is key to improving disease outcome. The laboratory diagnosis of LD depends on the demonstration of antibodies against Borrelia burgdorferi. There are few rapid point-of-care assays in the market based on lab-on-a-chip technology and none has been developed for LD. Further, current assays are poorly sensitive especially in early disease and cannot discriminate between the early and late stages of LD. New assays are needed and we plan to fill this unmet need. In this Phase I proposal our main objective is to use ultrasensitive microfluidics technology to develop and assess the performance of a rapid lab-on-a-chip, multi-antigenic, stage-specific, and quantitative Point-Of-Care (POC) assay for the serodiagnosis of Lyme disease (LD). After establishing the proof-of-concept of a lab-on-a-chip prototype first-tier Lyme disease test, we plan to move it towards commercialization in Phase II in partnership with Claros Diagnostics. This company specializes in transitioning technology from the laboratory to the physician's office or bedside and has recently received regulatory approval for a point-of-care system in Europe. A rapid, stage-specific assay for the serodiagnosis of Lyme disease is a much sought after device that will advance diagnostic testing beyond the current state of the art. PUBLIC HEALTH RELEVANCE: Lyme disease, the most common vector-borne infectious disease in the United States affects multiple organ systems. Although prompt diagnosis and treatment prevents or limits serious injury to the systems affected, current sero-diagnostics for Lyme disease lack sensitivity in early disease. Furthermore, there is no rapid point-of-care assay in the market based on lab-on-a-chip technology for Lyme disease. Our objective is to develop a novel front-line diagnostic testing device that enables simultaneous detection of multiple Borrelia burgdorferi antigens at the point of care. It is a quantitative rapid assay for serodiagnosis of Lyme disease that has the additional benefit of distinguishing between the stages of the disease. This low-cost portable device requires just one small finger-pricked volume of blood, and performs diagnostic testing that is as accurate as laboratory testing.

描述（由申请人提供）：由Borrelia Burgdorferi引起的，莱姆病（LD）会影响皮肤，心脏，关节或神经系统，导致一系列症状与其他疾病重叠。 LD是美国最常见的媒介传染性疾病，仍然是一个重大的公共卫生问题。早期诊断和治疗是改善疾病预后的关键。 LD的实验室诊断取决于抗伯氏伯氏抗体的抗体。基于实验室芯片技术，市场上几乎没有快速的护理点测定，而没有为LD开发。此外，当前的测定尤其是在早期疾病中敏感的，无法区分LD的早期和晚期。需要新的测定法，我们计划满足这种未满足的需求。在此阶段I建议中，我们的主要目标是使用超敏感的微富集技术来开发和评估快速的实验室芯片，多抗原，阶段特异性和定量式护理（POC）测定法（POC）测定法，以用于莱姆病（LD）的血清诊断。在建立了芯片上实验室原型莱姆病测试的概念证明后，我们计划与Claros Diagnostics合作将其转向II期商业化。该公司专门从事从实验室过渡到医师办公室或床旁的技术，并最近获得了欧洲护理系统的监管机构批准。莱姆病的塞拉氏诊断的快速，特定阶段的测定是一种备受追捧的装置，可以将诊断测试超越当前的技术状态。 公共卫生相关性：莱姆病是美国最常见的媒介传染性疾病，会影响多个器官系统。尽管迅速的诊断和治疗阻止或限制了受影响的系统的严重伤害，但目前针对莱姆病的血清诊断对早期疾病的敏感性缺乏敏感性。此外，基于莱姆病的实验室技术，市场上没有快速的护理测定法。我们的目标是开发一种新型的前线诊断测试装置，该设备能够同时检测护理点的多个伯氏burgdorferi抗原。这是莱姆病血清诊断的定量快速测定，它具有区分疾病阶段的额外好处。这种低成本的便携式设备只需要一小块手指添加的血液，并且进行诊断测试与实验室测试一样准确。