%0 Journal Article
%T Comparative Diagnostic Utility of SARS-CoV-2 Rapid Antigen and Molecular Testing in a Community Setting.
%A Kim AE
%A Bennett JC
%A Luiten K
%A O'Hanlon JA
%A Wolf CR
%A Magedson A
%A Han PD
%A Acker Z
%A Regelbrugge L
%A McCaffrey KM
%A Stone J
%A Reinhart D
%A Capodanno BJ
%A Morse SS
%A Bedford T
%A Englund JA
%A Boeckh M
%A Starita LM
%A Uyeki TM
%A Carone M
%A Weil A
%A Chu HY
%J J Infect Dis
%V 230
%N 2
%D 2024 Aug 16
%M 38531685
%F 7.759
%R 10.1093/infdis/jiae150
%X <B>BACKGROUND: </B>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.<BR><B>METHODS: </B>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).<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.