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Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serosurveys can estimate cumulative incidence for monitoring epidemics, requiring assessment of serologic assays to inform testing algorithm development and interpretation of results. We conducted a multilaboratory evaluation of 21 commerc...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Centers for Disease Control and Prevention
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8888213/ https://www.ncbi.nlm.nih.gov/pubmed/35202525 http://dx.doi.org/10.3201/eid2803.211885 |
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author | Stone, Mars Grebe, Eduard Sulaeman, Hasan Di Germanio, Clara Dave, Honey Kelly, Kathleen Biggerstaff, Brad J. Crews, Bridgit O. Tran, Nam Jerome, Keith R. Denny, Thomas N. Hogema, Boris Destree, Mark Jones, Jefferson M. Thornburg, Natalie Simmons, Graham Krajden, Mel Kleinman, Steve Dumont, Larry J. Busch, Michael P. |
author_facet | Stone, Mars Grebe, Eduard Sulaeman, Hasan Di Germanio, Clara Dave, Honey Kelly, Kathleen Biggerstaff, Brad J. Crews, Bridgit O. Tran, Nam Jerome, Keith R. Denny, Thomas N. Hogema, Boris Destree, Mark Jones, Jefferson M. Thornburg, Natalie Simmons, Graham Krajden, Mel Kleinman, Steve Dumont, Larry J. Busch, Michael P. |
author_sort | Stone, Mars |
collection | PubMed |
description | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serosurveys can estimate cumulative incidence for monitoring epidemics, requiring assessment of serologic assays to inform testing algorithm development and interpretation of results. We conducted a multilaboratory evaluation of 21 commercial high-throughput SARS-CoV-2 serologic assays using blinded panels of 1,000 highly characterized specimens. Assays demonstrated a range of sensitivities (96%–63%), specificities (99%–96%), and precision (intraclass correlation coefficient 0.55–0.99). Durability of antibody detection was dependent on antigen and immunoglobulin targets; antispike and total Ig assays demonstrated more stable longitudinal reactivity than antinucleocapsid and IgG assays. Assays with high sensitivity, specificity, and durable antibody detection are ideal for serosurveillance, but assays demonstrating waning reactivity are appropriate for other applications, including correlation with neutralizing activity and detection of anamnestic boosting by reinfections. Assay performance must be evaluated in context of intended use, particularly in the context of widespread vaccination and circulation of SARS-CoV-2 variants. |
format | Online Article Text |
id | pubmed-8888213 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Centers for Disease Control and Prevention |
record_format | MEDLINE/PubMed |
spelling | pubmed-88882132022-03-02 Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications Stone, Mars Grebe, Eduard Sulaeman, Hasan Di Germanio, Clara Dave, Honey Kelly, Kathleen Biggerstaff, Brad J. Crews, Bridgit O. Tran, Nam Jerome, Keith R. Denny, Thomas N. Hogema, Boris Destree, Mark Jones, Jefferson M. Thornburg, Natalie Simmons, Graham Krajden, Mel Kleinman, Steve Dumont, Larry J. Busch, Michael P. Emerg Infect Dis Research Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serosurveys can estimate cumulative incidence for monitoring epidemics, requiring assessment of serologic assays to inform testing algorithm development and interpretation of results. We conducted a multilaboratory evaluation of 21 commercial high-throughput SARS-CoV-2 serologic assays using blinded panels of 1,000 highly characterized specimens. Assays demonstrated a range of sensitivities (96%–63%), specificities (99%–96%), and precision (intraclass correlation coefficient 0.55–0.99). Durability of antibody detection was dependent on antigen and immunoglobulin targets; antispike and total Ig assays demonstrated more stable longitudinal reactivity than antinucleocapsid and IgG assays. Assays with high sensitivity, specificity, and durable antibody detection are ideal for serosurveillance, but assays demonstrating waning reactivity are appropriate for other applications, including correlation with neutralizing activity and detection of anamnestic boosting by reinfections. Assay performance must be evaluated in context of intended use, particularly in the context of widespread vaccination and circulation of SARS-CoV-2 variants. Centers for Disease Control and Prevention 2022-03 /pmc/articles/PMC8888213/ /pubmed/35202525 http://dx.doi.org/10.3201/eid2803.211885 Text en https://creativecommons.org/licenses/by/4.0/Emerging Infectious Diseases is a publication of the U.S. Government. This publication is in the public domain and is therefore without copyright. All text from this work may be reprinted freely. Use of these materials should be properly cited. |
spellingShingle | Research Stone, Mars Grebe, Eduard Sulaeman, Hasan Di Germanio, Clara Dave, Honey Kelly, Kathleen Biggerstaff, Brad J. Crews, Bridgit O. Tran, Nam Jerome, Keith R. Denny, Thomas N. Hogema, Boris Destree, Mark Jones, Jefferson M. Thornburg, Natalie Simmons, Graham Krajden, Mel Kleinman, Steve Dumont, Larry J. Busch, Michael P. Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications |
title | Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications |
title_full | Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications |
title_fullStr | Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications |
title_full_unstemmed | Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications |
title_short | Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications |
title_sort | evaluation of commercially available high-throughput sars-cov-2 serologic assays for serosurveillance and related applications |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8888213/ https://www.ncbi.nlm.nih.gov/pubmed/35202525 http://dx.doi.org/10.3201/eid2803.211885 |
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