TY - JOUR
T1 - 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
AU - Smith, Richard D.
AU - Johnson, J. Kristie
AU - Clay, Colleen
AU - Girio-Herrera, Leo
AU - Stevens, Diane
AU - Abraham, Michael
AU - Zimand, Paul
AU - Ahlman, Mark
AU - Gimigliano, Sheri
AU - Zhao, Richard
AU - Hildenbrand, Cynthia
AU - Barrueto, Fermin
AU - Leekha, Surbhi
N1 - Publisher Copyright:
©
PY - 2022/8/24
Y1 - 2022/8/24
N2 - 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.
AB - 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.
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U2 - 10.1017/ice.2021.281
DO - 10.1017/ice.2021.281
M3 - Article
C2 - 34162449
AN - SCOPUS:85108678841
SN - 0899-823X
VL - 43
SP - 968
EP - 973
JO - Infection Control and Hospital Epidemiology
JF - Infection Control and Hospital Epidemiology
IS - 8
ER -