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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...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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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. |
format | Online Article Text |
id | pubmed-9860642 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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