Clinical Evaluation of Sofia Rapid Antigen Assay for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 among Emergency Department to Hospital Admissions
AuthorSmith, Richard D
Johnson, J Kristie
JournalInfection Control and Hospital Epidemiology
PublisherCambridge University Press
MetadataShow full item record
AbstractObjective: 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: Two community hospitals in Maryland. From 9/21/2020 to 12/3/2020, 2887 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 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: Overall agreement, sensitivity, and specificity for all patients was 97.9%, 76.6% (95% confidence interval (CI): 71%, 82%), and 99.7% (95% CI: 99%, 100%), respectively. No differences in performance were seen between asymptomatic and symptomatic individuals. As RT-PCR Ct increased, sensitivity of the antigen assay decreased. Mean turnaround time for the antigen assay and RT-PCR was 1.2 (95% CI: 1.0, 1.3) and 20.1 (95% CI: 18.9, 40.3) hours, respectively (p<0.001). No transmission from antigen-negative/RT-PCR-positive patients was identified. Conclusions: While 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.
KeywordSofia SARS rapid antigen fluorescent immunoassay (FIA)
Sofia SARS antigen FIA
Identifier to cite or link to this itemhttp://hdl.handle.net/10713/16128
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