Hostname: page-component-8448b6f56d-dnltx Total loading time: 0 Render date: 2024-04-25T05:33:16.927Z Has data issue: false hasContentIssue false
  • English
  • Français

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
Get access Rights & Permissions [Opens in a new window]

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
Check for updates
Copyright
© The Author(s), 2021 Published by Cambridge University Press on behalf of The Society for Healthcare Epidemiology of America

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Machhi, J, Herskovitz, J, Senan, AM, et al. The natural history, pathobiology, and clinical manifestations of SARS-CoV-2 infections. J Neuroimmune Pharmacol 2020;15:359–386 CrossRefGoogle ScholarPubMed
Guidance document. Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised). Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff. Food and Drug Administration website. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised. Published May 2020. Accessed June 23, 2021.Google Scholar
Nikolai, LA, Meyer, CG, Kremsner, PG, Velavan, TP. Asymptomatic SARS coronavirus 2 infection: invisible yet invincible. Int J Infect Dis 2020;100:112–116.CrossRefGoogle ScholarPubMed
Ravi, N, Cortade, DL, Ng, E, Wang, SX. Diagnostics for SARS-CoV-2 detection: a comprehensive review of the FDA-EUA COVID-19 testing landscape. Biosens Bioelectron 2020;165:112454.CrossRefGoogle ScholarPubMed
Reusken, C, Broberg, EK, Haagmans, B, et al. Laboratory readiness and response for novel coronavirus (2019-nCoV) in expert laboratories in 30 EU/EEA countries, January 2020. Euro Surveill 2020;25(6):2000082.CrossRefGoogle ScholarPubMed
Roy, S, Paul, SK, Barman, TK, et al. SARS-CoV-2 Detection using real-time PCR by a commercial diagnostic kit. Mymensingh Med J 2020;29:596–600.Google ScholarPubMed
Esbin, MN, Whitney, ON, Chong, S, Maurer, A, Darzacq, X, Tjian, R. Overcoming the bottleneck to widespread testing: a rapid review of nucleic acid testing approaches for COVID-19 detection. RNA 2020;26:771–783.CrossRefGoogle ScholarPubMed
Larremore, DB, Wilder, B, Lester, E, et al. Test sensitivity is secondary to frequency and turnaround time for COVID-19 surveillance. medRxiv 2020. doi: 10.1101/2020.06.22.20136309.CrossRefGoogle Scholar
Global Research Collaboration for Infectious Disease Preparedness. COVID-19: Public Health Emergency of International Concern (PHEIC). Global Research and Innovation Forum: Towards a research roadmap, 02/11/2020–02/12/2020. World Health Organization website. https://www.who.int/blueprint/priority-diseases/key434action/Global_Research_Forum_FINAL_VERSION_for_web_14_feb_2020.pdf?ua=1. Accessed June 23, 2021.Google Scholar
Sofia® SARS Antigen FIA [package insert, EUA]. San Diego, CA: Quidel Corporation; 2020.Google Scholar
Buchan, BW, Hoff, JS, Gmehlin, CG, et al. Distribution of SARS-CoV-2 PCR cycle threshold values provide practical insight into overall and target-specific sensitivity among symptomatic patients. Am J Clin Pathol 2020;154:479–485.CrossRefGoogle ScholarPubMed
Loeffelholz, MJ, Alland, D, Butler-Wu, SM, et al. Multicenter evaluation of the Cepheid Xpert Xpress SARS-CoV-2 test. J Clin Microbiol 2020;58(8). doi: 10.1128/JCM.00926-20.CrossRefGoogle Scholar
Burbelo, PD, Riedo, FX, Morishima, C, et al. Sensitivity in detection of antibodies to nucleocapsid and spike proteins of severe acute respiratory syndrome coronavirus 2 in patients with coronavirus disease 2019. J Infect Dis 2020;222:206–213.CrossRefGoogle Scholar
COVID-19 target product profiles for priority diagnostics to support response to the COVID-19 pandemic v.1.0. World Health Organization website. https://www.who.int/publications/m/item/covid-19-target-product-profiles-for-priority-diagnostics-to-supportresponse-to-the-covid-19-pandemic-v.0.1. Published September 29, 2020. Accessed June 23, 2021.Google Scholar
Lanser, L, Bellmann-Weiler, R, Ottl, KW, et al. Evaluating the clinical utility and sensitivity of SARS-CoV-2 antigen testing in relation to RT-PCR Ct values Infection 2020. doi: 10.1007/s15010-020-01542-0.CrossRefGoogle Scholar
Xu, K, Chen, Y, Yuan, J, et al. Factors associated with prolonged viral RNA shedding in patients with coronavirus disease 2019 (COVID-19). Clin Infect Dis 2020;71:799–806.CrossRefGoogle Scholar
He, X, Lau, EHY, Wu, P, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med 2020;26(5):672–675.CrossRefGoogle ScholarPubMed
Yu, X, Sun, S, Shi, Y, Wang, H, Zhao, R, Sheng, J. 2020. SARS-CoV-2 viral load in sputum correlates with risk of COVID-19 progression. Crit Care 24:170.CrossRefGoogle ScholarPubMed
Liu, Y, Yan, L-M, Wan, L, et al. 2020. Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis 20:656–657.CrossRefGoogle ScholarPubMed
SoRelle, JA, Mahimainathan, L, McCormick-Baw, C, et al. Saliva for use with a point-of-care assay for the rapid diagnosis of COVID-19. Clin Chim Acta 2020;510:685–686.CrossRefGoogle Scholar
Sheridan, C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol 2020;38:515–518.CrossRefGoogle Scholar
Vashist, SK. Point-of-care diagnostics: recent advances and trends. Biosensors (Basel) 2017;7(4). doi: 10.3390/bios7040062.CrossRefGoogle Scholar
Dinnes, J, Deeks, JJ, Adriano, A, et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev 2020;8:CD013705.Google Scholar
Fenollar, F, Bouam, A, Ballouche, M, et al. Evaluation of the Panbio COVID-19 rapid antigen detection test device for the screening of patients with COVID-19. J Clin Microbiol 2020. doi: 10.1128/JCM.02589-20.CrossRefGoogle Scholar
Hirotsu, Y, Maejima, M, Shibusawa, M, et al. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. Int J Infect Dis 2020;99:397–402 CrossRefGoogle ScholarPubMed
Young, S, Taylor, SN, Cammarata, CL, et al. Clinical evaluation of BD Veritor SARS-CoV-2 point-of-care test performance compared to PCR-based testing and versus the Sofia 2 SARS Antigen point-of-care test. J Clin Microbiol 2020. doi: 10.1128/JCM.02338-20.CrossRefGoogle Scholar
Scohy, A, Anantharajah, A, Bodeus, M, Kabamba-Mukadi, B, Verroken, A, Rodriguez-Villalobos, H. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol 2020;129:104455.CrossRefGoogle ScholarPubMed
Dohla, M, Boesecke, C, Schulte, B, et al. Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity. Public Health 2020;182:170–172.CrossRefGoogle Scholar
Kucirka, LM, Lauer, SA, Laeyendecker, O, Boon, D, Lessler, J. Variation in false-negative rate of reverse transcriptase polymerase chain reaction-based SARS-CoV-2 tests by time since exposure. Ann Intern Med 2020;173:262–267.CrossRefGoogle ScholarPubMed
Mina, MJ, Peto, TE, Garcia-Finana, M, Semple, MG, Buchan, IE. Clarifying the evidence on SARS-CoV-2 antigen rapid tests in public health responses to COVID-19. Lancet 2021;397:1425–1427.CrossRefGoogle ScholarPubMed
Supplementary material: File

Smith et al. supplementary material

Table S1

Download Smith et al. supplementary material(File)
File 15.4 KB