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- Title
Comparative Diagnostic Utility of SARS-CoV-2 Rapid Antigen and Molecular Testing in a Community Setting.
- Authors
Kim, Ashley E; Bennett, Julia C; Luiten, Kyle; O'Hanlon, Jessica A; Wolf, Caitlin R; Magedson, Ariana; Han, Peter D; Acker, Zack; Regelbrugge, Lani; McCaffrey, Kathryn M; Stone, Jeremey; Reinhart, David; Capodanno, Benjamin J; Morse, Stephen S; Bedford, Trevor; Englund, Janet A; Boeckh, Michael; Starita, Lea M; Uyeki, Timothy M; Carone, Marco
- 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, 5757 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% confidence interval [CI], 49.6%–56.4%) and 98.8% (95% CI, 98.5%–99.0%), respectively. Sensitivity was comparatively higher for Ag-RDTs used 1 day after rRT-PCR (69.0%), 4–7 days after 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. Conclusions 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.
- Subjects
REVERSE transcriptase polymerase chain reaction; RAPID diagnostic tests; SARS-CoV-2 Omicron variant; ANTIGEN analysis; SARS-CoV-2
- Publication
Journal of Infectious Diseases, 2024, Vol 230, Issue 2, p363
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jiae150