Description of Collaborative Activity: |
Currently, the assays to measure immunogenicity of a flu vaccine are serologically based hemagglutinin inhibition and microneutralization assays. The assay results vary across laboratories, making it difficult to compare results across multiple sites. FDA standardized the qPCR based neutralization assay and qualified and tested the assay using human samples and compared it to the currently used method (comparability studies). The assay allows for quantitation of results which could be compared across multiple sites using standardized reagents and could have regulatory impact since results from clinical trials evaluating different vaccine candidates can be compared globally. |
