SBIR-STTR Award

A multiple antigen direct elisa for diagnosing equine inefctious anemia infection
Award last edited on: 2/27/02

Sponsored Program
SBIR
Awarding Agency
USDA
Total Award Amount
$255,000
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Russell L Wolz

Company Information

HedgePath Pharmaceuticals Inc (AKA: Commonwealth Biotechnologies Inc)

324 South Hyde Park Avenue Suite 350
Tampa, FL 33606
   (813) 864-2555
   N/A
   www.hedgepathpharma.com
Location: Single
Congr. District: 14
County: Hillsborough

Phase I

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
1997
Phase I Amount
$55,000
Equine infectious anemia virus (EIAV) is a retrovirus that causes a chronic infection in horses. In the absence of a vaccine, the control of this disease depends on the diagnosis and elimination of infected horses. Currently approved diagnostic procedures utilize agargel diffusion (AGID), or enzyme-linked immunosorbant (ELISA) methodologies to detect antibodies against the virus in horse sera as evidence of infection. Although the AGID procedure has been the industry standard, it is inherently less sensitive, much slower, and subject to considerable variation in interpretation, when compared to ELISA methods. Current ELISA methods utilize either a direct sandwich procedure based on a synthetic peptide corresponding to a region of the small envelope glycoprotein, or an antibody competition format utilizing monoclonal antibodies directed against the major core protein (p-26) of the virus. In either case, a single antigen is used. The major problem with the current ELISA assays is the observation that each misses some positive samples. In addition, the competition ELISA is prone to false positives. This project is aimed at demonstrating the feasibility of combining recombinant protein methodology, synthetic peptides, and a novel conjugation procedure to make a rapid, sensitive, and specific diagnostic test for this important viral pathogen of horses.Applications:Successful development of this assay would provide a rapid and accurate test for the EIA virus. This would allow the elimination of infected horses, which would, in turn, facilitate the control of this disease. The economic consequences of the failure to diagnose infected animals, as well as the destruction of incorrectly diagnosed animals would be avoided.

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
1998
Phase II Amount
$200,000
Equine infectious anemia (EIA) is a chronic debilitating disease which affects horses, donkeys, and their relatives. Although a USDA mandated eradication program has been in place for almost 30 years, the disease persists in an endemic state due in part to inaccurate diagnoses of animals. No single foolproof test is currently commercially available. Thus, the goal of this project is to improve the accuracy and sensitivity of one of the EIA assays currently in widespread use. Our Phase I results, included in this Phase II proposal, show that including multiple solid phase antigens in an ELISA assay format gives a significant improvement over the current single antigen assay. In Phase II, a final prototype assay will be optimized and produced in sufficient quantities to conduct an extensive field test.Applications:Quantitative data obtained during prototype optimization will demonstrate the accuracy and reproducibility of the new assay. Results of the extensive field test will be used to compare the diagnoses based on the new assay with those of other assays currently in use. Analysis of these results will be critical not only to its approval for commercial use, but to the marketing of the new test. It is believed that the field test results should lead to USDA approval and commercialization of this product in the near future.