Open AccessQualification of the Hemagglutination Inhibition Assay in Support of Pandemic Influenza Vaccine Licensure
Author(s) -
Diana L. Noah,
Heather Hill,
David Hines,
E. Lucile White,
Mark Wolff
Publication year - 2009
Publication title -
clinical and vaccine immunology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.649
H-Index - 77
eISSN - 1556-6811
pISSN - 1556-679X
DOI - 10.1128/cvi.00368-08
Subject(s) - hemagglutination assay , virology , immunogenicity , pandemic , licensure , vaccination , titer , live attenuated influenza vaccine , antigen , biology , influenza vaccine , medicine , immunology , virus , covid-19 , infectious disease (medical specialty) , disease , nursing , pathology
Continued outbreaks of highly pathogenic avian influenza over the past decade have spurred global efforts to develop antivirals and vaccines. As part of vaccine development, standard methods are needed for determining serum antibody titers in response to vaccination. Hemagglutination inhibition (HAI) assays are appropriate for assessing the immunogenicity of pandemic influenza vaccines in support of license approval. We demonstrate that a rigorous qualification of the HAI assay for H5N1 influenza virus, evaluating for precision, intermediate precision, linearity, range, specificity, and robustness, satisfies the intent of regulatory guidance for assay validation despite the lack of availability of specific reference standard antigens and antisera.