Description of Collaborative Activity: |
Improvements in neutralization assays, in terms of standardization and throughput potential, for Respiratory Syncytial Virus (RSV) would facilitate the development of novel vaccines and therapeutics and enhance the ability to perform large-scale seroepidemiological studies. FDA developed a qPCR based assay which considerably shortens the testing time and increases the output compared to the standard neutralization assays. Because a standardized assay for measuring neutralization would have an impact on regulatory decisions, research conducted by the Food and Drug Administration (FDA) can have significant impact on establishing guidelines and standards that can be used by the outside community during product development. |
