Clinical evaluation of Sofia Rapid Antigen Assay for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among emergency department to hospital admissions.

ABSTRACT

OBJECTIVE: To determine the utility of the Sofia SARS rapid antigen fluorescent immunoassay (FIA) to guide hospital-bed placement of patients being admitted through the emergency department (ED). DESIGN: Cross-sectional analysis of a clinical quality improvement study. SETTING: This study was conducted in 2 community hospitals in Maryland from September 21, 2020, to December 3, 2020. In total, 2,887 patients simultaneously received the Sofia SARS rapid antigen FIA and SARS-CoV-2 RT-PCR assays on admission through the ED. METHODS: Rapid antigen results and symptom assessment guided initial patient placement while confirmatory RT-PCR was pending. The sensitivity, specificity, positive predictive values, and negative predictive values of the rapid antigen assay were calculated relative to RT-PCR, overall and separately for symptomatic and asymptomatic patients. Assay sensitivity was compared to RT-PCR cycle threshold (Ct) values. Assay turnaround times were compared. Clinical characteristics of RT-PCR-positive patients and potential exposures from false-negative antigen assays were evaluated. RESULTS: For all patients, overall agreement was 97.9%; sensitivity was 76.6% (95% confidence interval [CI], 71%-82%), and specificity was 99.7% (95% CI, 99%-100%). We detected no differences in performance between asymptomatic and symptomatic individuals. As RT-PCR Ct increased, the sensitivity of the antigen assay decreased. The mean turnaround time for the antigen assay was 1.2 hours (95% CI, 1.0-1.3) and for RT-PCR it was 20.1 hours (95% CI, 18.9-40.3) (P < .001). No transmission from antigen-negative/RT-PCR-positive patients was identified. CONCLUSIONS: Although not a replacement for RT-PCR for detection of all SARS-CoV-2 infections, the Sofia SARS antigen FIA has clinical utility for potential initial timely patient placement.