Center for Biologics Evaluation and Research (CBER) DBPAP/ Amb a 1-Specific Aptamers

PER AMENDMENT 1 - Proposal Receipt date/time extended to 9/27/2024 at 12:00 pm EST. _________________________________________________________________________________ Introduction Development of Amb a 1- Specific capture and biotin-labeled detection Aptamers for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA) Background In the United States ragweed allergen extracts are standardized, which means that their potencies are determined in comparison to a US Reference Standard. Potency of the extract is determined by measuring Amb a 1 content. The Laboratory of Immunobiochemistry (LIB) needs to develop reference standard Amb a 1-specific capture and biotin-labeled detection monoclonal aptamers suitable for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA) to measure biological potencies of commercial ragweed pollen extracts marketed in the United States. Scope Amb a 1-specific capture and biotin-labeled detection monoclonal antibodies suitable for use in Enzyme Linked Immunosorbent Assay (ELISA)/ImmunoEnzymetric Assay (IEMA).