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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
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.
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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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