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Laboratory-Based SARS-CoV-2 Receptor Binding Domain Serologic Assays Perform with Equivalent Sensitivity and Specificity to Commercial FDA-EUA Approved Tests

During early phases of the SARS-CoV-2 epidemic, many research laboratories repurposed their efforts towards developing diagnostic testing that could aid public health surveillance while commercial and public diagnostic laboratories developed capacity and validated large scale testing methods. Simult...

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Autores principales: Nehring, Mary, Pugh, Sierra, Dihle, Tina, Gallichotte, Emily, Nett, Terry, Weber, Eric, Mayo, Christie, Lynn, Lori, Ebel, Greg, Fosdick, Bailey K., VandeWoude, Sue
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9860642/
https://www.ncbi.nlm.nih.gov/pubmed/36680146
http://dx.doi.org/10.3390/v15010106
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author Nehring, Mary
Pugh, Sierra
Dihle, Tina
Gallichotte, Emily
Nett, Terry
Weber, Eric
Mayo, Christie
Lynn, Lori
Ebel, Greg
Fosdick, Bailey K.
VandeWoude, Sue
author_facet Nehring, Mary
Pugh, Sierra
Dihle, Tina
Gallichotte, Emily
Nett, Terry
Weber, Eric
Mayo, Christie
Lynn, Lori
Ebel, Greg
Fosdick, Bailey K.
VandeWoude, Sue
author_sort Nehring, Mary
collection PubMed
description During early phases of the SARS-CoV-2 epidemic, many research laboratories repurposed their efforts towards developing diagnostic testing that could aid public health surveillance while commercial and public diagnostic laboratories developed capacity and validated large scale testing methods. Simultaneously, the rush to produce point-of-care and diagnostic facility testing resulted in FDA Emergency Use Authorization with scarce and poorly validated clinical samples. Here, we review serologic test results from 186 serum samples collected in early phases of the pandemic (May 2020) from skilled nursing facilities tested with six laboratory-based and two commercially available assays. Serum neutralization titers were used to set cut-off values using positive to negative ratio (P/N) analysis to account for batch effects. We found that laboratory-based receptor binding domain (RBD) binding assays had equivalent or superior sensitivity and specificity compared to commercially available tests. We also determined seroconversion rate and compared with qPCR outcomes. Our work suggests that research laboratory assays can contribute reliable surveillance information and should be considered important adjuncts to commercial laboratory testing facilities during early phases of disease outbreaks.
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spelling pubmed-98606422023-01-22 Laboratory-Based SARS-CoV-2 Receptor Binding Domain Serologic Assays Perform with Equivalent Sensitivity and Specificity to Commercial FDA-EUA Approved Tests Nehring, Mary Pugh, Sierra Dihle, Tina Gallichotte, Emily Nett, Terry Weber, Eric Mayo, Christie Lynn, Lori Ebel, Greg Fosdick, Bailey K. VandeWoude, Sue Viruses Article During early phases of the SARS-CoV-2 epidemic, many research laboratories repurposed their efforts towards developing diagnostic testing that could aid public health surveillance while commercial and public diagnostic laboratories developed capacity and validated large scale testing methods. Simultaneously, the rush to produce point-of-care and diagnostic facility testing resulted in FDA Emergency Use Authorization with scarce and poorly validated clinical samples. Here, we review serologic test results from 186 serum samples collected in early phases of the pandemic (May 2020) from skilled nursing facilities tested with six laboratory-based and two commercially available assays. Serum neutralization titers were used to set cut-off values using positive to negative ratio (P/N) analysis to account for batch effects. We found that laboratory-based receptor binding domain (RBD) binding assays had equivalent or superior sensitivity and specificity compared to commercially available tests. We also determined seroconversion rate and compared with qPCR outcomes. Our work suggests that research laboratory assays can contribute reliable surveillance information and should be considered important adjuncts to commercial laboratory testing facilities during early phases of disease outbreaks. MDPI 2022-12-30 /pmc/articles/PMC9860642/ /pubmed/36680146 http://dx.doi.org/10.3390/v15010106 Text en © 2022 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
Nehring, Mary
Pugh, Sierra
Dihle, Tina
Gallichotte, Emily
Nett, Terry
Weber, Eric
Mayo, Christie
Lynn, Lori
Ebel, Greg
Fosdick, Bailey K.
VandeWoude, Sue
Laboratory-Based SARS-CoV-2 Receptor Binding Domain Serologic Assays Perform with Equivalent Sensitivity and Specificity to Commercial FDA-EUA Approved Tests
title Laboratory-Based SARS-CoV-2 Receptor Binding Domain Serologic Assays Perform with Equivalent Sensitivity and Specificity to Commercial FDA-EUA Approved Tests
title_full Laboratory-Based SARS-CoV-2 Receptor Binding Domain Serologic Assays Perform with Equivalent Sensitivity and Specificity to Commercial FDA-EUA Approved Tests
title_fullStr Laboratory-Based SARS-CoV-2 Receptor Binding Domain Serologic Assays Perform with Equivalent Sensitivity and Specificity to Commercial FDA-EUA Approved Tests
title_full_unstemmed Laboratory-Based SARS-CoV-2 Receptor Binding Domain Serologic Assays Perform with Equivalent Sensitivity and Specificity to Commercial FDA-EUA Approved Tests
title_short Laboratory-Based SARS-CoV-2 Receptor Binding Domain Serologic Assays Perform with Equivalent Sensitivity and Specificity to Commercial FDA-EUA Approved Tests
title_sort laboratory-based sars-cov-2 receptor binding domain serologic assays perform with equivalent sensitivity and specificity to commercial fda-eua approved tests
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9860642/
https://www.ncbi.nlm.nih.gov/pubmed/36680146
http://dx.doi.org/10.3390/v15010106
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