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

描述（由申请人提供）：由伯氏疏螺旋体引起的莱姆病（LD）可以影响皮肤，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是美国最常见的媒介传播传染病，仍然是一个重要的公共卫生问题。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对伯氏疏螺旋体抗体的证明。市场上很少有基于芯片实验室技术的快速即时检测方法，也没有针对LD的检测方法。此外，目前的检测方法敏感性较差，特别是在早期疾病中，无法区分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微流体技术来开发和评估快速芯片实验室、多抗原、阶段特异性和定量护理点（POC）检测莱姆病（LD）血清诊断的性能。在建立了芯片实验室一级莱姆病测试原型的概念验证后，我们计划与Claros Diagnostics合作将其推向商业化的第二阶段。该公司专注于将技术从实验室过渡到医生办公室或床边，最近在欧洲获得了护理点系统的监管批准。用于莱姆病血清诊断的快速、阶段特异性检测是一种备受追捧的设备，它将推动诊断测试超越目前的技术水平。

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.