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

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 thatis as accurate as laboratory testing.