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A multi-laboratory study of diverse RSV neutralization assays indicates feasibility for harmonization with an international standard

A current barrier to the standardized evaluation of respiratory syncytial virus (RSV) vaccine candidates is the wide variety of virus neutralization assay formats currently in use for assessing immunogenicity. Assay formats vary widely in labor intensiveness, duration, and sample throughput. Further...

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Detalles Bibliográficos
Autores principales: Hosken, Nancy, Plikaytis, Brian, Trujillo, Carrie, Mahmood, Kutub, Higgins, Deborah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Science 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5439532/
https://www.ncbi.nlm.nih.gov/pubmed/28476625
http://dx.doi.org/10.1016/j.vaccine.2017.04.053
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author Hosken, Nancy
Plikaytis, Brian
Trujillo, Carrie
Mahmood, Kutub
Higgins, Deborah
author_facet Hosken, Nancy
Plikaytis, Brian
Trujillo, Carrie
Mahmood, Kutub
Higgins, Deborah
author_sort Hosken, Nancy
collection PubMed
description A current barrier to the standardized evaluation of respiratory syncytial virus (RSV) vaccine candidates is the wide variety of virus neutralization assay formats currently in use for assessing immunogenicity. Assay formats vary widely in labor intensiveness, duration, and sample throughput. Furthermore, the cell lines and virus strains used are not consistent among formats. The purpose of this multi-laboratory study was to assess the variability across a diverse array of assay formats that quantitate RSV neutralizing antibodies. Using a common specimen panel, the degree of overall agreement among existing assays was evaluated to inform on the need for harmonization of assay results. A total of 12 laboratories participated in the blinded survey study by testing a panel comprised of 57 samples chosen to span the reportable titer range of the assays. An independent statistical analysis was conducted to measure overall agreement of assay results. This analysis showed that precision was consistently high, whereas agreement varied widely among assays. To examine whether agreement could be improved, we conducted a harmonization exercise using a variety of sample types as pseudo standards. The results showed that the level of agreement could be improved, and provided information on the suitability of samples for developing an international standard.
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spelling pubmed-54395322017-05-31 A multi-laboratory study of diverse RSV neutralization assays indicates feasibility for harmonization with an international standard Hosken, Nancy Plikaytis, Brian Trujillo, Carrie Mahmood, Kutub Higgins, Deborah Vaccine Article A current barrier to the standardized evaluation of respiratory syncytial virus (RSV) vaccine candidates is the wide variety of virus neutralization assay formats currently in use for assessing immunogenicity. Assay formats vary widely in labor intensiveness, duration, and sample throughput. Furthermore, the cell lines and virus strains used are not consistent among formats. The purpose of this multi-laboratory study was to assess the variability across a diverse array of assay formats that quantitate RSV neutralizing antibodies. Using a common specimen panel, the degree of overall agreement among existing assays was evaluated to inform on the need for harmonization of assay results. A total of 12 laboratories participated in the blinded survey study by testing a panel comprised of 57 samples chosen to span the reportable titer range of the assays. An independent statistical analysis was conducted to measure overall agreement of assay results. This analysis showed that precision was consistently high, whereas agreement varied widely among assays. To examine whether agreement could be improved, we conducted a harmonization exercise using a variety of sample types as pseudo standards. The results showed that the level of agreement could be improved, and provided information on the suitability of samples for developing an international standard. Elsevier Science 2017-05-25 /pmc/articles/PMC5439532/ /pubmed/28476625 http://dx.doi.org/10.1016/j.vaccine.2017.04.053 Text en © 2017 The Authors. Published by Elsevier Ltd. http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Hosken, Nancy
Plikaytis, Brian
Trujillo, Carrie
Mahmood, Kutub
Higgins, Deborah
A multi-laboratory study of diverse RSV neutralization assays indicates feasibility for harmonization with an international standard
title A multi-laboratory study of diverse RSV neutralization assays indicates feasibility for harmonization with an international standard
title_full A multi-laboratory study of diverse RSV neutralization assays indicates feasibility for harmonization with an international standard
title_fullStr A multi-laboratory study of diverse RSV neutralization assays indicates feasibility for harmonization with an international standard
title_full_unstemmed A multi-laboratory study of diverse RSV neutralization assays indicates feasibility for harmonization with an international standard
title_short A multi-laboratory study of diverse RSV neutralization assays indicates feasibility for harmonization with an international standard
title_sort multi-laboratory study of diverse rsv neutralization assays indicates feasibility for harmonization with an international standard
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5439532/
https://www.ncbi.nlm.nih.gov/pubmed/28476625
http://dx.doi.org/10.1016/j.vaccine.2017.04.053
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