A Rapid Point-of-Care Assay for the Diagnosis of Lyme Disease

DESCRIPTION provided by applicant Lyme disease caused by infection with Borrelia burgdorferi is the most common vector borne infectious disease in North America and Europe Early disease can be effectively cured with antibiotics however untreated late disseminated infection can result in permanent damage to the nervous and musculoskeletal systems Therefore early diagnosis is critical for ensuring good patient outcomes The laboratory diagnosis of Lyme disease is dependent upon the serological detection of antibodies against B burgdorferi However the sensitivity of current IgM and IgG Lyme disease serodiagnostic assays seldom exceeds for the detection of early disease More effective diagnostic assays are needed Serodiagnostics utilizing synthetic peptides have demonstrated significant improvements in sensitivity and specificity for the detection of early Lyme disease The focus of this application is the development of a rapid point of care POC device that utilizes an assay target consisting of a mixture of synthetic peptides that are highly specific for proteins expressed by B burgdorferi during early infection A multi peptide POC assay would offer the benefits of high specificity from the use of peptides unique to B burgdorferi elevate sensitivity from the use of peptides from multiple Bb antigens and rapid diagnosis A POC assay would also improve upon existing conventional assays by reducing the time of accurate diagnosis to a few minutes rather than several days This would improve patient outcome by reducing the likelihood of developing potentially debilitating late stage disease through early antibiotic intervention PUBLIC HEALTH RELEVANCE The CDC estimates that there are Lyme disease cases per year in the United States http www cdc gov lyme stats humanCases html Lyme disease is clinically progressive and if left untreated can result in debilitating permanent damage to the nervous and musculoskeletal systems Early diagnosis and treatment is critical to avoiding disease progression however current diagnostic assays are often unable to detect early disease The focus of this application is the development of a sensitive and specific point of care assay that will provide immediate serological detection of antibodies against Borrelia burgdorferi the causative agent of Lyme disease to aid in physician diagnosis Accurate rapid diagnosis will improve patient outcomes by reducing the likelihood of developing potentially debilitating late stage disease through early antibiotic intervention