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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.

SUBMITTER: Smith RD 

PROVIDER: S-EPMC8376850 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Publications

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.

Smith Richard D RD   Johnson J Kristie JK   Clay Colleen C   Girio-Herrera Leo L   Stevens Diane D   Abraham Michael M   Zimand Paul P   Ahlman Mark M   Gimigliano Sheri S   Zhao Richard R   Hildenbrand Cynthia C   Barrueto Fermin F   Leekha Surbhi S  

Infection control and hospital epidemiology 20210624 8


<h4>Objective</h4>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).<h4>Design</h4>Cross-sectional analysis of a clinical quality improvement study.<h4>Setting</h4>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  ...[more]

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