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Simple, Quantitative and Highly Specific Antibody Detection of Lyme Disease

Posted May 20 2010 5:00pm

Description of Invention:
This invention uses the Luciferase Immunoprecipitation System (LIPS) as a highly specific and high throughput method for diagnosing Borrelia burgdorferi (Bb) infection, a causative agent of Lyme disease. Many antigens, fused to the renilla luciferase (RUC) system, were tested for their ability to detect the disease; however, a novel synthetic protein called VOLVO displayed the highest sensitivity and specificity of those tested. VOLVO demonstrated 94% sensitivity and 100% specificity and markedly out-performed the C6 ELISA test (currently the most sensitive test available, with 76% sensitivity and 98% specificity) in an analysis of independent validation serum sets. Unlike the C6 ELISA, the VOVO LIPS assay displayed a wide dynamic range of antibody detection spanning over a 10,000-fold range without serum dilution. These results indicate that LIPS screening method using VOVO or other Bb antigens offer a more convenient, efficient and quantitative approach to serological screening of antibodies to Lyme disease.

The VOVO LIPS test may benefit from a large market as it could potentially become part of a routine screening panel for Lyme disease. In addition to its high sensitivity and specificity, the test also provides a rapid, simple and high-through-put approach for efficient screening of the disease. It may also be adapted for detection of Borrelia species endemic to other regions of the world.

Applications:
  • Increased sensitivity and specificity for detection of Lyme disease
  • Rapid and convenient detection of Lyme disease


Development Status:
Early Stage

Inventors:
Peter D Burbelo (NIDCR)
Adriana Marques (NIAID)
Michael J Iadarola (NIDCR)


Patent Status:
HHS, Reference No. E-036-2010/0
US, Application No. 61/312,520 filed 10 Mar 2010


Relevant Publication:
  1. PD Burbelo et al. Rapid, Simple, Quantitative, and Highly Sensitive Antibody Detection for Lyme Disease. Clin Vaccine Immunol. 2010 Apr 14; Epub ahead of print, doi:10.1128/CVI.00476-09. [ PubMed: 20392886 ]


Licensing Status:
Available for licensing.

Collaborative Research Opportunity:
The National Institute of Dental and Craniofacial Research, Laboratory of Sensory Biology, Neurobiology and Pain Therapeutics Section, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact David W. Bradley, Ph.D. at 301-402-0540 or bradleyda@nidcr.nih.gov .


Portfolios:
Infectious Diseases
Infectious Diseases - Diagnostics



For Additional Information Please Contact:
Jeffrey James Ph.D.
NIH Office of Technology Transfer
100 N. Charles St., 5th Floor,
Baltimore, MD 21201
United States
Email: anos@mail.nih.gov


Ref No: 2113

Updated: 05/2010

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