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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

Part of: SARS-CoV-2/COVID-19

Published online by Cambridge University Press:  24 June 2021

Richard D. Smith Open the ORCID record for Richard D. Smith [Opens in a new window] ,
J. Kristie Johnson ,
Colleen Clay ,
Leo Girio-Herrera ,
Diane Stevens ,
Michael Abraham ,
Paul Zimand ,
Mark Ahlman ,
Sheri Gimigliano  and
Richard Zhao
...Show all authors
Richard D. Smith*
Affiliation:
University of Maryland School of Medicine, Baltimore, Maryland
J. Kristie Johnson
Affiliation:
University of Maryland School of Medicine, Baltimore, Maryland
Colleen Clay
Affiliation:
Upper Chesapeake Medical Center, Bel Air, Maryland
Leo Girio-Herrera
Affiliation:
University of Maryland School of Medicine, Baltimore, Maryland
Diane Stevens
Affiliation:
Upper Chesapeake Medical Center, Bel Air, Maryland
Michael Abraham
Affiliation:
University of Maryland School of Medicine, Baltimore, Maryland Upper Chesapeake Medical Center, Bel Air, Maryland
Paul Zimand
Affiliation:
Upper Chesapeake Medical Center, Bel Air, Maryland
Mark Ahlman
Affiliation:
Upper Chesapeake Medical Center, Bel Air, Maryland
Sheri Gimigliano
Affiliation:
Upper Chesapeake Medical Center, Bel Air, Maryland University of Maryland Medical System, Baltimore, Maryland
Richard Zhao
Affiliation:
University of Maryland School of Medicine, Baltimore, Maryland
Cynthia Hildenbrand
Affiliation:
Upper Chesapeake Medical Center, Bel Air, Maryland
Fermin Barrueto
Affiliation:
University of Maryland School of Medicine, Baltimore, Maryland Upper Chesapeake Medical Center, Bel Air, Maryland
Surbhi Leekha
Affiliation:
University of Maryland School of Medicine, Baltimore, Maryland
*
Author for correspondence: Richard D. Smith, E-mail: Richard.smith@umaryland.edu
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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.

Type
Original Article
Information
Infection Control & Hospital Epidemiology , Volume 43 , Issue 8 , August 2022 , pp. 968 - 973
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Copyright
© The Author(s), 2021 Published by Cambridge University Press on behalf of The Society for Healthcare Epidemiology of America

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