title: A monoclonal antibody-based immunoassay for measuring the potency of 2009 pandemic influenza H1N1 vaccines.
abstract: BACKGROUND
  The potency of inactivated influenza vaccines is determined using a single radial immunodiffusion (SRID) assay. This assay is relatively easy to standardize, it is not technically demanding, and it is capable of measuring the potency of several vaccine strain subtypes in a multivalent vaccine. Nevertheless, alternative methods that retain the major advantages of the SRID, but with a greater dynamic range of measurement and with reduced reagent requirements, are needed.
  
  
  OBJECTIVE
  The feasibility of an ELISA-based assay format was explored as an alternative potency assay for inactivated influenza vaccines.
  
  
  METHODS
  Several murine monoclonal antibodies (mAbs), specific for the 2009 pandemic H1N1 influenza virus hemagglutinin (HA), were evaluated for their potential to capture and quantify HA antigen. Vaccine samples, obtained from four licensed influenza vaccine manufacturers, included monovalent bulk vaccine, monovalent vaccine, and trivalent vaccine. Traditional SRID potency assays were run in parallel with the mAb-ELISA potency assay using the reference antigen standard appropriate for the vaccine samples being tested.
  
  
  RESULTS
  The results indicated that the ELISA potency assay can quantify HA over a wide range of concentrations, including vaccine at subpotent doses, and the ELISA and SRID potency values correlated well for most vaccine samples. Importantly, the assay was capable of quantifying A/California HA in a trivalent formulation.
  
  
  CONCLUSIONS
  This study demonstrates the general feasibility of the mAb approach and strongly suggests that such ELISAs have potential for continued development as an alternative method to assay the potency of inactivated influenza vaccines.
authors.affiliation: Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA.
authors.forename: Falko
authors.initials: F
authors.lastname: Schmeisser
authors.forename: Anupama
authors.initials: A
authors.lastname: Vasudevan
authors.forename: Jackeline
authors.initials: J
authors.lastname: Soto
authors.forename: Arunima
authors.initials: A
authors.lastname: Kumar
authors.forename: Ollie
authors.initials: O
authors.lastname: Williams
authors.forename: Jerry P
authors.initials: JP
authors.lastname: Weir
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000032:analysis; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000737:chemistry*; D007252:Influenza Vaccines / Q000032:analysis*; D007251:Influenza, Human / Q000821:virology*; D051379:Mice; D015164:Vaccines, Inactivated / Q000032:analysis*
chemical_list: D000911:Antibodies, Monoclonal; C543345:H1N1 virus hemagglutinin; D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: Influenza virus vaccine; monoclonal antibody; potency assay
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