Real-world performance of SARS-Cov-2 serology tests in the United States, 2020.
<h4>Background</h4>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.<h4>Methods</h4>Six health systems esti...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2023-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0279956 |
| _version_ | 1797788287910281216 |
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| author | Carla V Rodriguez-Watson Anthony M Louder Carly Kabelac Christopher M Frederick Natalie E Sheils Elizabeth H Eldridge Nancy D Lin Benjamin D Pollock Jennifer L Gatz Shaun J Grannis Rohit Vashisht Kanwal Ghauri Camille Knepper Sandy Leonard Peter J Embi Garrett Jenkinson Reyna Klesh Omai B Garner Ayan Patel Lisa Dahm Aiden Barin Dan M Cooper Tom Andriola Carrie L Byington Bridgit O Crews Atul J Butte Jeff Allen |
| author_facet | Carla V Rodriguez-Watson Anthony M Louder Carly Kabelac Christopher M Frederick Natalie E Sheils Elizabeth H Eldridge Nancy D Lin Benjamin D Pollock Jennifer L Gatz Shaun J Grannis Rohit Vashisht Kanwal Ghauri Camille Knepper Sandy Leonard Peter J Embi Garrett Jenkinson Reyna Klesh Omai B Garner Ayan Patel Lisa Dahm Aiden Barin Dan M Cooper Tom Andriola Carrie L Byington Bridgit O Crews Atul J Butte Jeff Allen |
| author_sort | Carla V Rodriguez-Watson |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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. |
| first_indexed | 2024-03-13T01:33:28Z |
| format | Article |
| id | doaj.art-e9a15bc2622142d7b29c87d6a448ed8f |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-03-13T01:33:28Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-e9a15bc2622142d7b29c87d6a448ed8f2023-07-04T05:32:40ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01182e027995610.1371/journal.pone.0279956Real-world performance of SARS-Cov-2 serology tests in the United States, 2020.Carla V Rodriguez-WatsonAnthony M LouderCarly KabelacChristopher M FrederickNatalie E SheilsElizabeth H EldridgeNancy D LinBenjamin D PollockJennifer L GatzShaun J GrannisRohit VashishtKanwal GhauriCamille KnepperSandy LeonardPeter J EmbiGarrett JenkinsonReyna KleshOmai B GarnerAyan PatelLisa DahmAiden BarinDan M CooperTom AndriolaCarrie L ByingtonBridgit O CrewsAtul J ButteJeff Allen<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.https://doi.org/10.1371/journal.pone.0279956 |
| spellingShingle | Carla V Rodriguez-Watson Anthony M Louder Carly Kabelac Christopher M Frederick Natalie E Sheils Elizabeth H Eldridge Nancy D Lin Benjamin D Pollock Jennifer L Gatz Shaun J Grannis Rohit Vashisht Kanwal Ghauri Camille Knepper Sandy Leonard Peter J Embi Garrett Jenkinson Reyna Klesh Omai B Garner Ayan Patel Lisa Dahm Aiden Barin Dan M Cooper Tom Andriola Carrie L Byington Bridgit O Crews Atul J Butte Jeff Allen Real-world performance of SARS-Cov-2 serology tests in the United States, 2020. PLoS ONE |
| 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 |
| url | https://doi.org/10.1371/journal.pone.0279956 |
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