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

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AI120364-01A1
Application #
9135755
Study Section
Special Emphasis Panel (ZRG1-IDM-V (12)B)
Program Officer
Ilias, Maliha R
Project Start
2016-06-10
Project End
2016-11-30
Budget Start
2016-06-10
Budget End
2016-11-30
Support Year
1
Fiscal Year
2016
Total Cost
$151,776
Indirect Cost
Name
Biopeptides, Inc.
Department
Type
DUNS #
140704532
City
East Setauket
State
NY
Country
United States
Zip Code
11733
D'Arco, Christina; Dattwyler, Raymond J; Arnaboldi, Paul M (2017) Borrelia burgdorferi-specific IgA in Lyme Disease. EBioMedicine 19:91-97