Advanced DPP technology for rapid animal-side detection of bovine tuberculosis

Bovine tuberculosis (TB), a zoonotic disease caused by Mycobacterium bovis, continues to plague the cattle industry in the United States (US) and worldwide. Current diagnostic methods are inadequate; therefore, improved tests are urgently needed for disease control/eradication. The goal of the proposed research is to develop a simple, rapid, accurate, and cost-effective blood test for bovine TB in cattle. The assay will use proprietary Dual Path Platform (DPP) technology and rationally selected antigens of M. bovis to detect specific antibodies animal-side within 15-20 minutes under field conditions.Phase I has two technical objectives: 1) identify key antigens, and 2) develop a DPP test prototype. Novel M. bovis antigens will be screened out of a large panel of recombinant candidates using serum samples from M. bovis-inoculated cattle. Novel polyepitope fusions will be designed for highly sensitive multi-antigen cocktails providing >90% serodiagnostic accuracy. DPP test prototype will be evaluated with extended panels of well-characterized serum samples. Phase II studies will focus on product development, validation, and field evaluation in preparation for regulatory approval.The proposed research will be translated into significant commercial applications. The Chembio manufacturing facility in Medford, NY, is registered with FDA and licensed by USDA. The company has an extensive track record of new diagnostic product commercialization and an established network of international distributors. A new blood test with superior performance and practical features will improve bovine TB control/eradication programs. Thus, the proposed research will meet the goals of the USDA Program Priorities and Societal Challenge Areas related to animal production and protection, and it will satisfy the public interest to increase food security and promote exports of agricultural biotechnology.