{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T01:39:22Z","timestamp":1773020362101,"version":"3.50.1"},"reference-count":28,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2014,8,2]],"date-time":"2014-08-02T00:00:00Z","timestamp":1406937600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/3.0\/"}],"funder":[{"DOI":"10.13039\/100012399","name":"BARDA","doi-asserted-by":"crossref","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Influenza Resp Viruses"],"published-print":{"date-parts":[[2014,9]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>The potency of inactivated influenza vaccines is determined using a single radial immunodiffusion (<jats:styled-content style=\"fixed-case\">SRID<\/jats:styled-content>) 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 <jats:styled-content style=\"fixed-case\">SRID<\/jats:styled-content>, but with a greater dynamic range of measurement and with reduced reagent requirements, are needed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>The feasibility of an <jats:styled-content style=\"fixed-case\">ELISA<\/jats:styled-content>\u2010based assay format was explored as an alternative potency assay for inactivated influenza vaccines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Several murine monoclonal antibodies (mAbs), specific for the 2009 pandemic <jats:styled-content style=\"fixed-case\">H<\/jats:styled-content>1<jats:styled-content style=\"fixed-case\">N<\/jats:styled-content>1 influenza virus hemagglutinin (<jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content>), were evaluated for their potential to capture and quantify <jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content> antigen. Vaccine samples, obtained from four licensed influenza vaccine manufacturers, included monovalent bulk vaccine, monovalent vaccine, and trivalent vaccine. Traditional <jats:styled-content style=\"fixed-case\">SRID<\/jats:styled-content> potency assays were run in parallel with the mAb\u2013<jats:styled-content style=\"fixed-case\">ELISA<\/jats:styled-content> potency assay using the reference antigen standard appropriate for the vaccine samples being tested.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The results indicated that the <jats:styled-content style=\"fixed-case\">ELISA<\/jats:styled-content> potency assay can quantify <jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content> over a wide range of concentrations, including vaccine at subpotent doses, and the <jats:styled-content style=\"fixed-case\">ELISA<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">SRID<\/jats:styled-content> potency values correlated well for most vaccine samples. Importantly, the assay was capable of quantifying A\/California <jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content> in a trivalent formulation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study demonstrates the general feasibility of the mAb approach and strongly suggests that such <jats:styled-content style=\"fixed-case\">ELISA<\/jats:styled-content>s have potential for continued development as an alternative method to assay the potency of inactivated influenza vaccines.<\/jats:p><\/jats:sec>","DOI":"10.1111\/irv.12272","type":"journal-article","created":{"date-parts":[[2014,8,2]],"date-time":"2014-08-02T06:29:03Z","timestamp":1406960943000},"page":"587-595","source":"Crossref","is-referenced-by-count":21,"title":["A monoclonal antibody\u2010based immunoassay for measuring the potency of 2009 pandemic influenza <scp>H<\/scp>1<scp>N<\/scp>1 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