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）：莱姆病（LD）由伯氏疏螺旋体引起，可影响皮肤、心脏、关节或神经系统，导致一系列与其他疾病重叠的症状。LD是美国最常见的病媒传染病，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结局的关键。LD的实验室诊断取决于对伯氏疏螺旋体抗体的证明。市场上几乎没有基于芯片实验室技术的快速即时检测，并且没有针对LD开发的检测。此外，目前的测定法灵敏度低，特别是在早期疾病中，并且不能区分LD的早期和晚期。需要新的检测方法，我们计划填补这一未满足的需求。在这个I期提案中，我们的主要目标是使用超灵敏的微流体技术来开发和评估用于莱姆病（LD）血清诊断的快速芯片实验室，多抗原，阶段特异性和定量床旁（POC）检测的性能。在建立了芯片实验室原型的概念验证后，我们计划与Claros Diagnostics合作，在第二阶段将其推向商业化。该公司专注于将技术从实验室转移到医生办公室或床边，最近已获得欧洲监管机构对即时护理系统的批准。用于莱姆病血清学诊断的快速、阶段特异性测定是一种备受追捧的装置，其将使诊断测试超越现有技术水平。 公共卫生相关性：莱姆病是美国最常见的病媒传染病，影响多个器官系统。虽然及时的诊断和治疗可以防止或限制对受影响系统的严重损伤，但目前莱姆病的血清诊断在早期疾病中缺乏敏感性。此外，市场上没有基于芯片实验室技术的快速即时检测莱姆病。我们的目标是开发一种新型的一线诊断检测设备，能够在护理点同时检测多种伯氏疏螺旋体抗原。这是一种用于莱姆病血清学诊断的定量快速测定，具有区分疾病阶段的额外益处。这种低成本的便携式设备只需要一个小的手指刺破血液量，并执行诊断测试，是准确的实验室测试。