Lyme disease (LD) cases due to Borrelia burgdorferi (Bb) are increasing. Assays to detect active infection are urgently needed. The primary objective of this proposal is to develop an assay for active infection based upon Bb specific immune complexes (IC) for immediate public use. There are 2 Specific Aims to prove the principle and confirm that l). BbIC become positive before free Bb antibody (Ab) in early infection 2). BbIC indicate active infection Samples are already banked from LD patients with both the pathognomic erythema migrans (EM) rash AND microbiological confirmation by Bb cultures. The rationale is that in many infections IC Ab can be found bound to its antigen (Ag) target earlier than the free Ab, and in contrast to free Ab, specific IC Ab reflects active infection. We will study serial blinded serum specimens at key time points. ELISA, immunoblot and clinical histories will be available. BbIC will be isolated by a proven simple technique, polyethylene glycol. BbIC Ag and Ab will be examined by immunoblots and ELISA. Focus will be on specific and in vivo expressed Bb Ags. Results will be statistically analyzed. Phase 2 is designed for broadscale usage and refinement of the assay.

Proposed Commercial Applications

The need for accurate laboratory diagnosis of active infection in Lyme disease is imperative. There are over 5 million serologic Lyme disease tests performed per year. None indicate active infection. They only indicate past infection. A test such as the Borrelia burgdorferi immune complex assay has high potential as a marker of active infection. It can also detect infection early than free antibody assays. Therefore this assay can fulfill a great need in Lyme disease diagnosis and has high market potential.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
4R44AI047553-02
Application #
6403165
Study Section
Special Emphasis Panel (ZRG1-SSS-K (01))
Program Officer
Baker, Phillip J
Project Start
2000-09-15
Project End
2006-08-31
Budget Start
2004-09-15
Budget End
2005-08-31
Support Year
2
Fiscal Year
2004
Total Cost
$391,664
Indirect Cost
Name
Bioscience Development, Inc.
Department
Type
DUNS #
145237025
City
New York
State
NY
Country
United States
Zip Code
10128
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Casjens, Sherwood R; Mongodin, Emmanuel F; Qiu, Wei-Gang et al. (2012) Genome stability of Lyme disease spirochetes: comparative genomics of Borrelia burgdorferi plasmids. PLoS One 7:e33280
Crowder, Chris D; Matthews, Heather E; Schutzer, Steven et al. (2010) Genotypic variation and mixtures of Lyme Borrelia in Ixodes ticks from North America and Europe. PLoS One 5:e10650
Wywial, Ewa; Haven, James; Casjens, Sherwood R et al. (2009) Fast, adaptive evolution at a bacterial host-resistance locus: the PFam54 gene array in Borrelia burgdorferi. Gene 445:26-37