Analytical performances of the point-of-care SIENNA™ COVID-19 Antigen Rapid Test for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swabs: A prospective evaluation during the COVID-19 second wave in France.

Abstract

OBJECTIVES:

We herein assessed the analytical performances of the antigen-rapid diagnostic test (Ag-RDT) SIENNA™ COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) (Salofa Oy, Salo, Finland), targeting the SARS-CoV-2 N nucleocapsid protein, for the diagnosis of COVID-19 in hospitalized patients with suspected SARS-CoV-2 infection, by reference to real-time RT-PCR (rRT-PCR).

METHODS:

Nasopharyngeal swabs were collected from patients with COVID-19-like illness during the second epidemic wave in Paris, France, among which 100 and 50 were positive and negative for SARS-CoV-2 RNA, respectively.

RESULTS:

Overall, the Ag-RDT showed high sensitivity, specificity, positive and negative predictive values of 90.0%, 100.0%, 100.0% and 98.1%, respectively, as well as high or almost perfect agreement (93.3%), reliability assessed by Cohen's κ coefficient (0.86), and accuracy assessed by Youden's J index (90%) to detect SARS-CoV-2. The analytical performances of the Ag-RDT remained high in the event of significant viral excretion (i.e., N gene Ct values ≤33 by reference rtRT-PCR), while the sensitivity of the Ag-RDT dropped to 69.6% with low or very low viral shedding (Ct > 33).

CONCLUSIONS:

The SIENNA™ Ag-RDT presents excellent analytical performances for viral loads ≤33 Ct, classically corresponding to situations of symptomatic COVID-19 and/or proven contagiousness.

• Authors: Ralph-Sydney Mboumba Bouassa, David Veyer, Hélène Péré, Laurent Bélec
• Journal: International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases (Int J Infect Dis) Vol. 106 Pg. 8-12 (May 2021) ISSN: 1878-3511 [Electronic] Canada
• PMID: 33746093 (Publication Type: Journal Article)
• Copyright: Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Antigens, Viral
• Nucleocapsid Proteins

Topics

• Adult
• Antigens, Viral (analysis)
• COVID-19 (diagnosis, epidemiology)
• COVID-19 Testing (methods)
• France (epidemiology)
• Humans
• Male
• Nasopharynx (virology)
• Nucleocapsid Proteins (analysis)
• Point-of-Care Testing
• Predictive Value of Tests
• Prospective Studies
• Reproducibility of Results
• SARS-CoV-2 (immunology)
• Sensitivity and Specificity
• Viral Load