In:
PLOS ONE, Public Library of Science (PLoS), Vol. 18, No. 2 ( 2023-2-3), p. e0279956-
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0279956
DOI:
10.1371/journal.pone.0279956.g001
DOI:
10.1371/journal.pone.0279956.g002
DOI:
10.1371/journal.pone.0279956.g003
DOI:
10.1371/journal.pone.0279956.g004
DOI:
10.1371/journal.pone.0279956.g005
DOI:
10.1371/journal.pone.0279956.g006
DOI:
10.1371/journal.pone.0279956.g007
DOI:
10.1371/journal.pone.0279956.g008
DOI:
10.1371/journal.pone.0279956.g009
DOI:
10.1371/journal.pone.0279956.t001
DOI:
10.1371/journal.pone.0279956.t002
DOI:
10.1371/journal.pone.0279956.t003
DOI:
10.1371/journal.pone.0279956.s001
DOI:
10.1371/journal.pone.0279956.s002
DOI:
10.1371/journal.pone.0279956.s003
DOI:
10.1371/journal.pone.0279956.s004
DOI:
10.1371/journal.pone.0279956.s005
DOI:
10.1371/journal.pone.0279956.s006
DOI:
10.1371/journal.pone.0279956.s007
DOI:
10.1371/journal.pone.0279956.s008
DOI:
10.1371/journal.pone.0279956.s009
DOI:
10.1371/journal.pone.0279956.r001
DOI:
10.1371/journal.pone.0279956.r002
DOI:
10.1371/journal.pone.0279956.r003
DOI:
10.1371/journal.pone.0279956.r004
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2023
detail.hit.zdb_id:
2267670-3
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