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, animal-side and cost-effective blood test for bovine TB in cattle. The assay will use Chembio proprietary Dual Path Platform (DPP) technology and rationally designed antigens of M. bovis to detect specific antibodies within 20 minutes under field conditions. Phase I studies have demonstrated the technical feasibility of the proposed approach. Several seroreactive antigens were identified which, when combined in our DPP assay, provided a diagnostic accuracy of ~95%. Proposed Phase II work has three technical objectives: 1) develop DPP BovidTB Assay, 2) evaluate test performance, and 3) validate the product in preparation for regulatory approval. Key antigen screening out of >100 novel M. bovis proteins will lead to designing efficient polyepitope fusion reagents for improved antibody detection. The DPP assay will be fully optimized and evaluated with extended panels of well-characterized serum specimens from cattle with confirmed M. bovis infection and from TB-free herds collected in the US, Brazil, the United Kingdom, and South Africa. Large-scale antigen production and DPP product manufacturing protocols will be validated. Portable optical readers will be evaluated to generate accurate quantitative data for objective DPP assay interpretation. Test performance evaluation results will be collected and analyzed to support regulatory submission. Upon successful completion of the Phase II work, Chembio will bring the new product to the US and international markets. The proposed research will be translated into significant commercial applications worldwide. 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, including DPP VetTB Assay for captive cervids and elephants, 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.
