Comparative diagnostic utility of SARS-CoV-2 rapid antigen and molecular testing in a community setting

Ashley E Kim; Julia C Bennett; Kyle Luiten; Jessica A O'Hanlon; Caitlin R Wolf; Ariana Magedson; Peter D Han; Zack Acker; Lani Regelbrugge; Kathryn M McCaffrey; Jeremey Stone; David Reinhart; Benjamin J Capodanno; Stephen S Morse; Trevor Bedford; Janet A Englund; Michael Boeckh; Lea M Starita; Timothy M Uyeki; Marco Carone; Ana Weil; Helen Y Chu

doi:10.1093/infdis/jiae150

Comparative diagnostic utility of SARS-CoV-2 rapid antigen and molecular testing in a community setting

J Infect Dis. 2024 Mar 26:jiae150. doi: 10.1093/infdis/jiae150. Online ahead of print.

Authors

Ashley E Kim^{1

2}, Julia C Bennett^{1

3}, Kyle Luiten¹, Jessica A O'Hanlon¹, Caitlin R Wolf¹, Ariana Magedson¹, Peter D Han^{4

5}, Zack Acker^{4

5}, Lani Regelbrugge^{4

5}, Kathryn M McCaffrey⁴, Jeremey Stone^{4

5}, David Reinhart^{4

5}, Benjamin J Capodanno^{4

5}, Stephen S Morse², Trevor Bedford^{4

5

6

7}, Janet A Englund⁸, Michael Boeckh^{1

6}, Lea M Starita^{4

5}, Timothy M Uyeki⁹, Marco Carone¹⁰, Ana Weil¹, Helen Y Chu¹

Affiliations

¹ Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, WA, USA.
² Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.
³ Department of Epidemiology, University of Washington, Seattle, WA, USA.
⁴ Brotman Baty Institute for Precision Medicine, Seattle, WA, USA.
⁵ Department of Genome Sciences, University of Washington, Seattle, WA, USA.
⁶ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
⁷ Howard Hughes Medical Institute, Seattle, WA, USA.
⁸ Seattle Children's Research Institute, Seattle, WA, USA.
⁹ Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
¹⁰ Department of Biostatistics, University of Washington, Seattle, WA, USA.

PMID: 38531685
DOI: 10.1093/infdis/jiae150

Abstract

Background: SARS-CoV-2 antigen-detection rapid diagnostic tests (Ag-RDTs) have become widely utilized but longitudinal characterization of their community-based performance remains incompletely understood.

Methods: This prospective longitudinal study at a large public university in Seattle, WA utilized remote enrollment, online surveys, and self-collected nasal swab specimens to evaluate Ag-RDT performance against real-time reverse transcription polymerase chain reaction (rRT-PCR) in the context of SARS-CoV-2 Omicron. Ag-RDT sensitivity and specificity within 1 day of rRT-PCR were evaluated by symptom status throughout the illness episode and Orf1b cycle threshold (Ct).

Results: From February to December 2022, 5,757 participants reported 17,572 Ag-RDT results and completed 12,674 rRT-PCR tests, of which 995 (7.9%) were rRT-PCR-positive. Overall sensitivity and specificity were 53.0% (95% CI: 49.6-56.4%) and 98.8% (98.5-99.0%), respectively. Sensitivity was comparatively higher for Ag-RDTs used 1 day after rRT-PCR (69.0%), 4 to 7 days post-symptom onset (70.1%), and Orf1b Ct ≤20 (82.7%). Serial Ag-RDT sensitivity increased with repeat testing ≥2 (68.5%) and ≥4 (75.8%) days after an initial Ag-RDT-negative result.

Conclusion: Ag-RDT performance varied by clinical characteristics and temporal testing patterns. Our findings support recommendations for serial testing following an initial Ag-RDT-negative result, especially among recently symptomatic persons or those at high-risk for SARS-CoV-2 infection.

Keywords: Ag-RDT; COVID-19; Omicron; PCR; community setting; concordance; self-tests; sensitivity; serial testing; symptom status.

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