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Reproducibility of serology assays for pandemic influenza H1N1: collaborative study to evaluate a candidate WHO International Standard
Authors:Wood John M  Major Diane  Heath Alan  Newman Robert W  Höschler Katja  Stephenson Iain  Clark Tristan  Katz Jacqueline M  Zambon Maria C
Affiliation:a National Institute for Biological Standards and Control, Health Protection Agency, Potters Bar, United Kingdom
b Centre for Infection, Health Protection Agency, Colindale, United Kingdom
c University of Leicester, Leicester, United Kingdom
d Centers for Disease Control and Prevention, Atlanta, GA, United States
Abstract:
Haemagglutination-inhibition (HI) and virus neutralisation (VN) assays are used to evaluate immunogenicity of pandemic H1N1 vaccines; however these bioassays are poorly standardised leading to inter-laboratory variation. A candidate International Standard (IS) for antibody to H1N1pdm virus (09/194) was prepared from pooled sera of subjects who had either recovered from H1N1pdm infection or who had been immunised with an adjuvanted subunit vaccine prepared from reassortant virus NYMC X-179A (derived from A/California/7/2009 virus). Ten laboratories from seven countries tested the candidate IS, 09/194 and a panel of human sera by HI and VN using the A/California/7/2009 virus (six laboratories) and/or the reassortant virus NYMC X-179A (ten laboratories). As expected, the inter-laboratory variability for HI and VN assay results was high. For results of antibody tests to NYMC X-179A, the % geometric coefficient of variation (%GCV) for 09/194 between laboratories was 83% for HI and 192% for VN. For tests of all sera, the median %GCV ranged from 95 to 345% for HI (80-fold variation) and 204 to 383% for VN (109-fold variation), but for the titres relative to 09/194 the median %GCV was much reduced (HI 34-231%; VN 44-214%). For tests of antibody to the A/California/7/2009 wild type virus there were similar reductions in %GCV when 09/194 was used.These results suggest that 09/194 will be of use to standardise assays of antibody to A/California/7/2009 vaccine and 09/194 has now been established by WHO as an IS for antibody to A/California/7/2009 with an assigned potency of 1300 IU per ml.
Keywords:Influenza   Serology   Haemagglutination-inhibition   Neutralisation   Antibody standard   Pandemic
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