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A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection

As the COVID-19 pandemic continues, variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continue to emerge. Immunogenicity evaluation of vaccines and identification of correlates of protection for vaccine effectiveness is critical to aid the development of vaccines against emerg...

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Autores principales: Zhu, Mingzhu, Cloney-Clark, Shane, Feng, Sheau-line, Parekh, Anand, Gorinson, Drew, Silva, David, Skonieczny, Paul, Wilson, Adjele, Kalkeri, Raj, Woo, Wayne, Cai, Miranda R., Fries, Louis, Glenn, Greg, Plested, Joyce S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10383018/
https://www.ncbi.nlm.nih.gov/pubmed/37512961
http://dx.doi.org/10.3390/microorganisms11071789
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author Zhu, Mingzhu
Cloney-Clark, Shane
Feng, Sheau-line
Parekh, Anand
Gorinson, Drew
Silva, David
Skonieczny, Paul
Wilson, Adjele
Kalkeri, Raj
Woo, Wayne
Cai, Miranda R.
Fries, Louis
Glenn, Greg
Plested, Joyce S.
author_facet Zhu, Mingzhu
Cloney-Clark, Shane
Feng, Sheau-line
Parekh, Anand
Gorinson, Drew
Silva, David
Skonieczny, Paul
Wilson, Adjele
Kalkeri, Raj
Woo, Wayne
Cai, Miranda R.
Fries, Louis
Glenn, Greg
Plested, Joyce S.
author_sort Zhu, Mingzhu
collection PubMed
description As the COVID-19 pandemic continues, variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continue to emerge. Immunogenicity evaluation of vaccines and identification of correlates of protection for vaccine effectiveness is critical to aid the development of vaccines against emerging variants. Anti-recombinant spike (rS) protein immunoglobulin G (IgG) quantitation in the systemic circulation (serum/plasma) is shown to correlate with vaccine efficacy. Thus, an enzyme-linked immunosorbent assay (ELISA)-based binding assay to detect SARS-CoV-2 (ancestral and variant strains) anti-rS IgG in human serum samples was developed and validated. This assay successfully met acceptance criteria for inter/intra-assay precision, specificity, selectivity, linearity, lower/upper limits of quantitation, matrix effects, and assay robustness. The analyte in serum was stable for up to 8 freeze/thaw cycles and 2 years in −80 °C storage. Similar results were observed for the Beta, Delta, and Omicron BA.1/BA.5/XBB.1.5 variant-adapted assays. Anti-rS IgG assay results correlated significantly with neutralization and receptor binding inhibition assays. In addition, usage of international reference standards allows data extrapolation to WHO international units (BAU/mL), facilitating comparison of results with other IgG assays. This anti-rS IgG assay is a robust, high-throughput method to evaluate binding IgG responses to S protein in serum, enabling rapid development of effective vaccines against emerging COVID-19 variants.
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spelling pubmed-103830182023-07-30 A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection Zhu, Mingzhu Cloney-Clark, Shane Feng, Sheau-line Parekh, Anand Gorinson, Drew Silva, David Skonieczny, Paul Wilson, Adjele Kalkeri, Raj Woo, Wayne Cai, Miranda R. Fries, Louis Glenn, Greg Plested, Joyce S. Microorganisms Article As the COVID-19 pandemic continues, variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continue to emerge. Immunogenicity evaluation of vaccines and identification of correlates of protection for vaccine effectiveness is critical to aid the development of vaccines against emerging variants. Anti-recombinant spike (rS) protein immunoglobulin G (IgG) quantitation in the systemic circulation (serum/plasma) is shown to correlate with vaccine efficacy. Thus, an enzyme-linked immunosorbent assay (ELISA)-based binding assay to detect SARS-CoV-2 (ancestral and variant strains) anti-rS IgG in human serum samples was developed and validated. This assay successfully met acceptance criteria for inter/intra-assay precision, specificity, selectivity, linearity, lower/upper limits of quantitation, matrix effects, and assay robustness. The analyte in serum was stable for up to 8 freeze/thaw cycles and 2 years in −80 °C storage. Similar results were observed for the Beta, Delta, and Omicron BA.1/BA.5/XBB.1.5 variant-adapted assays. Anti-rS IgG assay results correlated significantly with neutralization and receptor binding inhibition assays. In addition, usage of international reference standards allows data extrapolation to WHO international units (BAU/mL), facilitating comparison of results with other IgG assays. This anti-rS IgG assay is a robust, high-throughput method to evaluate binding IgG responses to S protein in serum, enabling rapid development of effective vaccines against emerging COVID-19 variants. MDPI 2023-07-11 /pmc/articles/PMC10383018/ /pubmed/37512961 http://dx.doi.org/10.3390/microorganisms11071789 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Zhu, Mingzhu
Cloney-Clark, Shane
Feng, Sheau-line
Parekh, Anand
Gorinson, Drew
Silva, David
Skonieczny, Paul
Wilson, Adjele
Kalkeri, Raj
Woo, Wayne
Cai, Miranda R.
Fries, Louis
Glenn, Greg
Plested, Joyce S.
A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection
title A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection
title_full A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection
title_fullStr A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection
title_full_unstemmed A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection
title_short A Severe Acute Respiratory Syndrome Coronavirus 2 Anti-Spike Immunoglobulin G Assay: A Robust Method for Evaluation of Vaccine Immunogenicity Using an Established Correlate of Protection
title_sort severe acute respiratory syndrome coronavirus 2 anti-spike immunoglobulin g assay: a robust method for evaluation of vaccine immunogenicity using an established correlate of protection
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10383018/
https://www.ncbi.nlm.nih.gov/pubmed/37512961
http://dx.doi.org/10.3390/microorganisms11071789
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