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dc.contributor.authorSmith, Richard D
dc.contributor.authorJohnson, J Kristie
dc.contributor.authorClay, Colleen
dc.contributor.authorGirio-Herrera, Leo
dc.contributor.authorStevens, Diane
dc.contributor.authorAbraham, Michael
dc.contributor.authorZimand, Paul
dc.contributor.authorAhlman, Mark
dc.contributor.authorGimigliano, Sheri
dc.contributor.authorZhao, Richard
dc.contributor.authorHildenbrand, Cynthia
dc.contributor.authorBarrueto, Fermin
dc.contributor.authorLeekha, Surbhi
dc.date.accessioned2021-07-06T12:51:04Z
dc.date.available2021-07-06T12:51:04Z
dc.date.issued2021-06-24
dc.identifier.urihttp://hdl.handle.net/10713/16128
dc.description.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.en_US
dc.description.urihttps://doi.org/10.1017/ice.2021.281en_US
dc.language.isoenen_US
dc.publisherCambridge University Pressen_US
dc.relation.ispartofInfection Control and Hospital Epidemiologyen_US
dc.subjectSofia SARS rapid antigen fluorescent immunoassay (FIA)en_US
dc.subjectSofia SARS antigen FIAen_US
dc.subject.meshCOVID-19 Testingen_US
dc.subject.meshImmunoassayen_US
dc.titleClinical Evaluation of Sofia Rapid Antigen Assay for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 among Emergency Department to Hospital Admissionsen_US
dc.typeArticleen_US
dc.identifier.doi10.1017/ice.2021.281
dc.identifier.pmid34162449
dc.source.beginpage1
dc.source.endpage22
dc.source.countryUnited States


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