BIOSTONE ANIMAL HEALTH LLC — Department of Agriculture SBIR Phase I: 8.3

Description

African swine fever (ASF) is a transboundary foreign animal disease caused by ASF virus (ASFV)and remains one of the largest threats to pork production worldwide. ASF was recently reported inDominican Republic and Haiti increasing concerns about the potential spread to U.S. soil. ASF isroutinely diagnosed by serological assays which offer important surveillance tools for biosecurity.Enzyme linked immuno-sorbent assays (ELISA) are used for serological surveillance of ASF butthere are no USDA-approved ASF ELISAs. ASF ELISAs on international markets have exhibitedlow sensitivity for detecting early infections vaccinations and low virulence strains. While ELISAis preferred for ASF screening confirmation tests are required. The immunoperoxidase test andindirect fluorescent antibody test are the only approved serological confirmatory tests but theyrequire handling ASFV which limits their accessibility. We aim to develop an ELISA confirmationtest which employs multiple recombinant ASFV antigens. This will be accessible to BioSafetyLevel 2 laboratories which are restricted from handling ASFV. We will screen and select ASFVantigens that have been under-utilized for diagnostic development and we will combine them withwell-characterize ASFV diagnostic antigens: p30 p54 and p72. We will develop the confirmationtest in collaboration with an OIE-recognized ASFV Reference Laboratory which enables us tovalidate prototypes with reference serum panels field samples experimental ASFV-infectionsamples and samples from vaccine field trials. During R&D we will produce reagents such asASFV antibodies and antigens which have applications for future R&D in ASFV researchalternative serological diagnostics and ASFV subunit vaccines.