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 50% for the detection of early disease (5, 8-14). 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 Statement: Public Health Relevance: The CDC estimates that there are 300,000 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.
NIH Spending Category: Arthritis; Biodefense; Bioengineering; Emerging Infectious Diseases; Infectious Diseases; Lyme Disease; Prevention; Vector-Borne Diseases
Project Terms: accurate diagnosis; Address; Adjustment Disorders; Antibiotics; Antibodies; Antigen Targeting; Antigens; B-Lymphocyte Epitopes; Bacteria; base; Bedside Testings; Binding Proteins; Biological Assay; Borrelia burgdorferi; Centers for Disease Control and Prevention (U.S.); Clinical; Collaborations; cross reactivity; DBL Oncoprotein; decorin binding protein B; Detection; Development; Devices; Diagnosis; Diagnostic; diagnostic assay; Disease; Disease Progression; Early Diagnosis; Early treatment; efficacy testing; Ensure; Enzyme-Linked Immunosorbent Assay; Epitopes; erythema migrans; Europe; Generations; Goals; Human; human disease; Immune response; Immunoglobulin G; Immunoglobulin M; improved; Individual; individual patient; Infection; Integrin Binding; Intervention; Laboratories; Laboratory Diagnosis; Left; Legal patent; linear transformation; Link; Lyme Arthritis; Lyme Disease; Maps; Musculoskeletal System; Nervous system structure; North America; OspC protein; Patient-Focused Outcomes; Patients; Peptides; Performance; Phase; Physicians; point of care; prevent; Proteins; prototype; public health relevance; rapid diagnosis; response; Rheumatoid Arthritis; Sensitivity and Specificity; Serodiagnoses; Serological; Serum; Small Business Innovation Research Grant; Specificity; Speed; Staging; synthetic peptide; Syphilis; Technology; Testing; Time; United States; Vector-transmitted infectious disease; Western Blotting; Work
