SBIR-STTR Award

Avian Influenza Virus (AIV) is persistent in wild birds and seasonal migration promotes transcontinental transmission between wild and domestic birds (poultry). Wild birds harbor low pathogenic avian influenza (LPAI) viruses which can mutate into highly pathogenic avian influenza (HPAI). Recent HPAI epidemics resulted in the loss of 22 million (Europe 2020) and 50 million 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 and surveillance of these subtypes is critical for biosecurity. Serological surveillance by enzyme-linked immunosorbent 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 AIV subtypes H5 and H7. We previously developed prototypes for the H5 and H7 cELISAs which require additional R&D and need to be evaluated across broader regions to validate their diagnostic performance. BioStone has expertise in developing ELISA and animal disease diagnostics and our collaborator Dr. Yohannes Berhane National Center for Foreign Animal Disease has expertise in AIV diagnostics and maintains an extensive collection of AIV-positive samples that will be used for cELISA validation.