Development of a Prototype, Performance and Evaluation, and Validation and Transition of a 3ABC Foot and Mouth Disease virus Competitive Enzyme-Linked Immunosorbent Assay Kit 

Principal Investigator(s): ,


These projects are the result of strong public/private/academic partnerships between The Institute for Infectious Animal Diseases (IIAD), the U.S. Department of Agriculture (USDA) Agricultural Research Service (ARS) and Animal and Plant Health Inspection Service (APHIS), Department of Homeland Security (DHS) Plum Island Animal Disease Center (PIADC), a veterinary diagnostics company, and the Texas A&M Medical Veterinary Diagnostics Laboratory (TVMDL). The project team is collaboratively developing a new Foot and Mouth Disease (FMD) serology diagnostic kit to differentiate vaccinated animals from those infected with the FMD virus (FMDv).

The core kit components include a 3ABC recombinant protein and a monoclonal antibody specific for an immunodominant B-cell epitope. This assay will utilize the 3B non-structural protein as a marker for non-vaccinated, infected animals and will be detected by competitive enzyme-linked immunosorbent assay (cELISA). These projects have demonstrated the kit’s usefulness as companion diagnostic to differentiate infected from animals vaccinated with conventional FMD vaccines and the newly licensed FMD adenoviral vaccine. Efficacy in identification of FMDv infected cattle, goats and swine have also been demonstrated.

Additional testing underway includes assay validation standards of the USDA National Animal Health Laboratory Network (NAHLN), including a full scale negative cohort in geographically distinct NAHLN labs, and transition of this cELISA to the laboratories within the NAHLN for both swine and cattle.

Outcomes and impacts

The goal of these programs is to have a FMD diagnostic test that is manufactured in the United States that can also be used as a Differentiation of Infected from Vaccinated Animals (DIVA) test to differentiate cattle vaccinated with next generation FMD vaccines. The current scope of these programs supports transition of a “research use” kit to the USDA NAHLN laboratories.

In June 2017, DHS announced that the USDA Center for Veterinary Biologics had granted the licensing of the diagnostic kit. The kit will be commercialized and sold by Veterinary Medical Research and Development (VMRD), Inc., a US manufacturer of veterinary diagnostics.

The customer of these projects is the USDA, specifically the NAHLN, who would use this assay (following proficiency validation training) under the direction of USDA APHIS Emergency Management in the response and recovery phases of a FMD outbreak in cattle in the United States, in which FMD vaccines may also be used as part of the FMD National Response Plan.