Real-world performance of SARS-Cov-2 serology tests in the United States, 2020
Author:
Rodriguez-Watson Carla V.ORCID, Louder Anthony M., Kabelac Carly, Frederick Christopher M.ORCID, Sheils Natalie E.ORCID, Eldridge Elizabeth H., Lin Nancy D., Pollock Benjamin D., Gatz Jennifer L., Grannis Shaun J.ORCID, Vashisht Rohit, Ghauri Kanwal, Knepper Camille, Leonard SandyORCID, Embi Peter J., Jenkinson Garrett, Klesh ReynaORCID, Garner Omai B., Patel Ayan, Dahm Lisa, Barin Aiden, Cooper Dan M., Andriola Tom, Byington Carrie L.ORCID, Crews Bridgit O., Butte Atul J.ORCID, Allen JeffORCID
Abstract
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.
Funder
Rockefeller Foundation Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation FDA, UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation
Publisher
Public Library of Science (PLoS)
Subject
Multidisciplinary
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