Clinical Evaluation of Sofia Rapid Antigen Assay for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 among Emergency Department to Hospital Admissions
dc.contributor.author | Smith, Richard D | |
dc.contributor.author | Johnson, J Kristie | |
dc.contributor.author | Clay, Colleen | |
dc.contributor.author | Girio-Herrera, Leo | |
dc.contributor.author | Stevens, Diane | |
dc.contributor.author | Abraham, Michael | |
dc.contributor.author | Zimand, Paul | |
dc.contributor.author | Ahlman, Mark | |
dc.contributor.author | Gimigliano, Sheri | |
dc.contributor.author | Zhao, Richard | |
dc.contributor.author | Hildenbrand, Cynthia | |
dc.contributor.author | Barrueto, Fermin | |
dc.contributor.author | Leekha, Surbhi | |
dc.date.accessioned | 2021-07-06T12:51:04Z | |
dc.date.available | 2021-07-06T12:51:04Z | |
dc.date.issued | 2021-06-24 | |
dc.identifier.uri | http://hdl.handle.net/10713/16128 | |
dc.description.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: 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. | en_US |
dc.description.uri | https://doi.org/10.1017/ice.2021.281 | en_US |
dc.language.iso | en | en_US |
dc.publisher | Cambridge University Press | en_US |
dc.relation.ispartof | Infection Control and Hospital Epidemiology | en_US |
dc.subject | Sofia SARS rapid antigen fluorescent immunoassay (FIA) | en_US |
dc.subject | Sofia SARS antigen FIA | en_US |
dc.subject.mesh | COVID-19 Testing | en_US |
dc.subject.mesh | Immunoassay | en_US |
dc.title | Clinical Evaluation of Sofia Rapid Antigen Assay for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 among Emergency Department to Hospital Admissions | en_US |
dc.type | Article | en_US |
dc.identifier.doi | 10.1017/ice.2021.281 | |
dc.identifier.pmid | 34162449 | |
dc.source.beginpage | 1 | |
dc.source.endpage | 22 | |
dc.source.country | United States |