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

Description

Avian Influenza Virus (AIV) is persistent in wild birds and seasonal migration promotestranscontinental transmission between wild and domestic birds (poultry). Wild birds harbor lowpathogenic avian influenza (LPAI) viruses which can mutate into highly pathogenic avianinfluenza (HPAI). Recent HPAI epidemics resulted in the loss of 22 million (Europe 2020) and 50million domestic poultry (U.S. 2014) and the current U.S. 2022 outbreak has resulted in loss of>46 million birds. AIV subtypes H5 and H7 are at highest risk of mutating into HPAI andsurveillance of these subtypes is critical for biosecurity. Serological surveillance by enzyme-linkedimmunosorbent assay (ELISA) is high throughput cost-effective and accessible to most labs.However there are no USDA-approved ELISAs to diagnose AIV subtypes. Therefore theobjectives of this project are to develop and validate competition ELISAs (cELISA) to detect AIVsubtypes H5 and H7. We previously developed prototypes for the H5 and H7 cELISAs whichrequire additional R&D and need to be evaluated across broader regions to validate their diagnosticperformance. BioStone has expertise in developing ELISA and animal disease diagnostics and ourcollaborator Dr. Yohannes Berhane National Center for Foreign Animal Disease has expertise inAIV diagnostics and maintains an extensive collection of AIV-positive samples that will be usedfor cELISA validation.