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A monoclonal antibody‐based immunoassay for measuring the potency of 2009 pandemic influenza <scp>H</scp> 1 <scp>N</scp> 1 vaccines
- Source :
- Influenza and Other Respiratory Viruses
- Publication Year :
- 2014
- Publisher :
- Wiley, 2014.
-
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. Objectives 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.
- Subjects :
- Pulmonary and Respiratory Medicine
Epidemiology
Influenza vaccine
medicine.drug_class
Hemagglutinin (influenza)
Enzyme-Linked Immunosorbent Assay
Hemagglutinin Glycoproteins, Influenza Virus
potency assay
Monoclonal antibody
Virus
Mice
Influenza A Virus, H1N1 Subtype
Antigen
Influenza, Human
Animals
Humans
Medicine
Potency
Radial immunodiffusion
biology
medicine.diagnostic_test
business.industry
Public Health, Environmental and Occupational Health
Antibodies, Monoclonal
Original Articles
Virology
Infectious Diseases
Vaccines, Inactivated
Influenza Vaccines
Influenza virus vaccine
monoclonal antibody
Immunoassay
Immunology
biology.protein
business
Subjects
Details
- ISSN :
- 17502659 and 17502640
- Volume :
- 8
- Database :
- OpenAIRE
- Journal :
- Influenza and Other Respiratory Viruses
- Accession number :
- edsair.doi.dedup.....7ae1178f27e3a28d30098da6197f05fa