Real-world performance of SARS-Cov-2 serology tests in the United States, 2020
BACKGROUND: Real-world performance of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) must be assessed. We describe overall trends in the performance of serology tests in the context of real-world implementation. METHODS: Six health systems estimated the odds of seropositivity and...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Public Library of Science
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9897562/ https://www.ncbi.nlm.nih.gov/pubmed/36735683 http://dx.doi.org/10.1371/journal.pone.0279956 |
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author | Rodriguez-Watson, Carla V. Louder, Anthony M. Kabelac, Carly Frederick, Christopher M. Sheils, Natalie E. Eldridge, Elizabeth H. Lin, Nancy D. Pollock, Benjamin D. Gatz, Jennifer L. Grannis, Shaun J. Vashisht, Rohit Ghauri, Kanwal Knepper, Camille Leonard, Sandy Embi, Peter J. Jenkinson, Garrett Klesh, Reyna Garner, Omai B. Patel, Ayan Dahm, Lisa Barin, Aiden Cooper, Dan M. Andriola, Tom Byington, Carrie L. Crews, Bridgit O. Butte, Atul J. Allen, Jeff |
author_facet | Rodriguez-Watson, Carla V. Louder, Anthony M. Kabelac, Carly Frederick, Christopher M. Sheils, Natalie E. Eldridge, Elizabeth H. Lin, Nancy D. Pollock, Benjamin D. Gatz, Jennifer L. Grannis, Shaun J. Vashisht, Rohit Ghauri, Kanwal Knepper, Camille Leonard, Sandy Embi, Peter J. Jenkinson, Garrett Klesh, Reyna Garner, Omai B. Patel, Ayan Dahm, Lisa Barin, Aiden Cooper, Dan M. Andriola, Tom Byington, Carrie L. Crews, Bridgit O. Butte, Atul J. Allen, Jeff |
author_sort | Rodriguez-Watson, Carla V. |
collection | PubMed |
description | BACKGROUND: Real-world performance of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) must be assessed. We describe overall trends in the performance of serology tests in the context of real-world implementation. METHODS: Six health systems estimated the odds of seropositivity and positive percent agreement (PPA) of serology test among people with confirmed SARS-CoV-2 infection by molecular test. In each dataset, we present the odds ratio and PPA, overall and by key clinical, demographic, and practice parameters. RESULTS: A total of 15,615 people were observed to have at least one serology test 14–90 days after a positive molecular test for SARS-CoV-2. We observed higher PPA in Hispanic (PPA range: 79–96%) compared to non-Hispanic (60–89%) patients; in those presenting with at least one COVID-19 related symptom (69–93%) as compared to no such symptoms (63–91%); and in inpatient (70–97%) and emergency department (93–99%) compared to outpatient (63–92%) settings across datasets. PPA was highest in those with diabetes (75–94%) and kidney disease (83–95%); and lowest in those with auto-immune conditions or who are immunocompromised (56–93%). The odds ratios (OR) for seropositivity were higher in Hispanics compared to non-Hispanics (OR range: 2.59–3.86), patients with diabetes (1.49–1.56), and obesity (1.63–2.23); and lower in those with immunocompromised or autoimmune conditions (0.25–0.70), as compared to those without those comorbidities. In a subset of three datasets with robust information on serology test name, seven tests were used, two of which were used in multiple settings and met the EUA requirement of PPA ≥87%. Tests performed similarly across datasets. CONCLUSION: Although the EUA requirement was not consistently met, more investigation is needed to understand how serology and molecular tests are used, including indication and protocol fidelity. Improved data interoperability of test and clinical/demographic data are needed to enable rapid assessment of the real-world performance of in vitro diagnostic tests. |
format | Online Article Text |
id | pubmed-9897562 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-98975622023-02-04 Real-world performance of SARS-Cov-2 serology tests in the United States, 2020 Rodriguez-Watson, Carla V. Louder, Anthony M. Kabelac, Carly Frederick, Christopher M. Sheils, Natalie E. Eldridge, Elizabeth H. Lin, Nancy D. Pollock, Benjamin D. Gatz, Jennifer L. Grannis, Shaun J. Vashisht, Rohit Ghauri, Kanwal Knepper, Camille Leonard, Sandy Embi, Peter J. Jenkinson, Garrett Klesh, Reyna Garner, Omai B. Patel, Ayan Dahm, Lisa Barin, Aiden Cooper, Dan M. Andriola, Tom Byington, Carrie L. Crews, Bridgit O. Butte, Atul J. Allen, Jeff PLoS One Research Article BACKGROUND: Real-world performance of COVID-19 diagnostic tests under Emergency Use Authorization (EUA) must be assessed. We describe overall trends in the performance of serology tests in the context of real-world implementation. METHODS: Six health systems estimated the odds of seropositivity and positive percent agreement (PPA) of serology test among people with confirmed SARS-CoV-2 infection by molecular test. In each dataset, we present the odds ratio and PPA, overall and by key clinical, demographic, and practice parameters. RESULTS: A total of 15,615 people were observed to have at least one serology test 14–90 days after a positive molecular test for SARS-CoV-2. We observed higher PPA in Hispanic (PPA range: 79–96%) compared to non-Hispanic (60–89%) patients; in those presenting with at least one COVID-19 related symptom (69–93%) as compared to no such symptoms (63–91%); and in inpatient (70–97%) and emergency department (93–99%) compared to outpatient (63–92%) settings across datasets. PPA was highest in those with diabetes (75–94%) and kidney disease (83–95%); and lowest in those with auto-immune conditions or who are immunocompromised (56–93%). The odds ratios (OR) for seropositivity were higher in Hispanics compared to non-Hispanics (OR range: 2.59–3.86), patients with diabetes (1.49–1.56), and obesity (1.63–2.23); and lower in those with immunocompromised or autoimmune conditions (0.25–0.70), as compared to those without those comorbidities. In a subset of three datasets with robust information on serology test name, seven tests were used, two of which were used in multiple settings and met the EUA requirement of PPA ≥87%. Tests performed similarly across datasets. CONCLUSION: Although the EUA requirement was not consistently met, more investigation is needed to understand how serology and molecular tests are used, including indication and protocol fidelity. Improved data interoperability of test and clinical/demographic data are needed to enable rapid assessment of the real-world performance of in vitro diagnostic tests. Public Library of Science 2023-02-03 /pmc/articles/PMC9897562/ /pubmed/36735683 http://dx.doi.org/10.1371/journal.pone.0279956 Text en © 2023 Watson et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Rodriguez-Watson, Carla V. Louder, Anthony M. Kabelac, Carly Frederick, Christopher M. Sheils, Natalie E. Eldridge, Elizabeth H. Lin, Nancy D. Pollock, Benjamin D. Gatz, Jennifer L. Grannis, Shaun J. Vashisht, Rohit Ghauri, Kanwal Knepper, Camille Leonard, Sandy Embi, Peter J. Jenkinson, Garrett Klesh, Reyna Garner, Omai B. Patel, Ayan Dahm, Lisa Barin, Aiden Cooper, Dan M. Andriola, Tom Byington, Carrie L. Crews, Bridgit O. Butte, Atul J. Allen, Jeff Real-world performance of SARS-Cov-2 serology tests in the United States, 2020 |
title | Real-world performance of SARS-Cov-2 serology tests in the United States, 2020 |
title_full | Real-world performance of SARS-Cov-2 serology tests in the United States, 2020 |
title_fullStr | Real-world performance of SARS-Cov-2 serology tests in the United States, 2020 |
title_full_unstemmed | Real-world performance of SARS-Cov-2 serology tests in the United States, 2020 |
title_short | Real-world performance of SARS-Cov-2 serology tests in the United States, 2020 |
title_sort | real-world performance of sars-cov-2 serology tests in the united states, 2020 |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9897562/ https://www.ncbi.nlm.nih.gov/pubmed/36735683 http://dx.doi.org/10.1371/journal.pone.0279956 |
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