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

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。

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.