Development of an Early Diagnostic Test for Johne\'s Disease in Cattle

NON-TECHNICAL SUMMARY: Johne\'s disease affects numerous ruminants (including cattle) in which it is characterized as a chronic wasting disease. Losses are estimated at $250 million annually in the U.S. alone. Johne\'s disease is inordinately difficult to diagnose. The purpose of this project is to develop a specific and sensitive monoclonal antibody-based test for Johne\'s disease. Project contact: C.A. Speer

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APPROACH: Generate monoclonal antibodies against Ag85a peptides and then test for reactivity and specificity against Ag85a from M. a. paratuberculosis in sera of infected cattle.

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PROGRESS: 2003/10 TO 2008/09<BR>
OUTPUTS: Johne\'s disease is one of the most devastating and economically important diseases in the livestock industry. The control of the disease in the U.S. has been unsuccessful mainly due to the lack of sensitive diagnostic test. We developed a novel serological diagnostic test for Johne\'s disease, which showed a sensitivity of higher than 95%. This project has resulted in three scientific publications in international peer-reviewed journals and appeared in Hoard\'s Dairyman Magazine, Angus Journal, Tennessee Land, Life & Science, and UTIA monthly news. In 2008, we were invited to contribute to a book chapter on Johne\'s disease diagnosis. Our findings were presented at eight scientific meetings and one invited seminar at USDA/ARS. For this project, we received four extramural grants and contracts from governmental and private agencies including the USDA National Research Initiative. Two patent applications were filed and one issued in October 2007. Based on the patents, we established collaborations with veterinary diagnostic companies for commercialization of the diagnostic test. One of the companies, BioVet, plans to start marketing the test in 2009. <BR>PARTICIPANTS: Lab members) C.A. Speer (Professor), Shigetoshi Eda (Research Assistant Professor), M. Cathy Scott (Research Associate), Brad Elliot (Master graduate student), Taylor Fielden (Master graduate student), Yumiko Kaneko (Volunteer Research Assistant), Keiko Eda (Research Coordinator), Adam Branscum (University of Kentucky), John Bannantine (USDA/ARS), Ray Waters (USDA/ARS), Robert Whitlock, (University of Pennsylvania), Andre Broes and Isabelle Caya (BioVet), Robert Shaw, Robert Foote (Oak Ridge National Laboratory) <BR>TARGET AUDIENCES: Veterinarians, dairy farmers, veterinary diagnostic companies, National Johne\'s Working Group, Johne\'s Disease Integrated Program, International Association for Paratuberculosis. <BR>PROJECT MODIFICATIONS: C. A. Speer was retired in July of 2007 and since then Shigetoshi Eda led this project.
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IMPACT: 2003/10 TO 2008/09<BR>
Patents: 1. Method for diagnosing infectious diseases, Patent issued on October 2, 2007, Serial number 10/832,761, S. Eda and C. A. Speer 2. Method for diagnosing infections, Patent filed on September 6, 2005, Serial number 11/220,156, C. A. Speer and S. Eda Funding: October, 2006 Graham Hickling (PI), S. Eda, Lisa Muller, and Mattew Gray, \"New Approaches to Wildlife Health: Monitoring and Managing Disease Spread Between Free-Ranging Wildlife, Livestock and Humans\" Hatch project at UT September, 2007 S. Eda (PI), \"Evaluation of Novel Absorbed Serum Enzyme-linked Immunosorbent Assays for Johne\'s Disease\". ($23,870 BioVet Phase I) August, 2007 S. Eda (PI) and Adam Branscum \"Optimization and Evaluation of Novel Absorbed Serum and Milk Enzyme-linked Immunosorbent Assays for Johne\'s Disease\". ($293,000, 2 years, USDA National Research Initiative). February, 2008 S. Eda (PI), \"Evaluation of Novel Absorbed Serum Enzyme-linked Immunosorbent Assays for Johne\\\'s Disease.\\\" ($71,000, BioVet Phase II) April, 2008 S. Eda (PI), Robert Shaw, Robert Foote, and Adam Branscum \\\"Development of an on-site diagnostic device for Johne\\\'s disease\\\" ($34,625, Johne\\\'s Disease Integrated Program) Johne\\\'s disease (JD) or paratuberculosis, caused by Mycobacterium avium subsp. paratuberculosis (MAP), affects many ruminants and, after several years of infection, a chronic wasting disease develops which may ultimately result in death. JD occurs in domestic and wild animals worldwide. In the United States, JD causes an estimated annual loss of $200-$250 million to the agricultural economy. In herds with 10 percent or more cull cows showing clinical signs of JD, the economic impact was estimated to be $227 per cow. A major reason for unsuccessful control of JD in the U.S. is that current diagnostic tests for the disease suffer low sensitivity (<30% accuracy). We developed a highly sensitive diagnostic test for JD in 2006 and improved significantly the sensitivity of the test this year. It is likely that the improved test will have positive impacts on JD control program.