Full text

Turn on search term navigation

© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

With the continuous spread of new SARS-CoV-2 variants of concern (VOCs), the monitoring of diagnostic test performances is mandatory. We evaluated the changes in antigen diagnostic tests’ (ADTs) accuracy along the Delta to Omicron VOCs transition, exploring the N protein mutations possibly affecting ADT sensitivity and assessing the best sampling site for the diagnosis of Omicron infections. In total, 5175 subjects were enrolled from 1 October 2021 to 15 July 2022. The inclusion criteria were SARS-CoV-2 ADT combined with a same-day RT-PCR swab test. For the sampling site analysis, 61 patients were prospectively recruited during the Omicron period for nasal and oral swab analyses by RT-PCR. Next-Generation Sequencing data were obtained to evaluate the different sublineages. Using RT-PCR as a reference, 387 subjects resulted in becoming infected and the overall sensitivity of the ADT decreased from 63% in the Delta period to 33% in the Omicron period. This decrease was highly statistically significant (p < 0.001), and no decrease in viral load was detected at the RNA level. The nasal site presented a significantly higher viral load than the oral site during the Omicron wave. The reduced detection rate of Omicron infections by ADT should be considered in the global testing strategy to preserve accurate diagnoses across the changing SARS-CoV-2 variants.

Details

Title
Wide Real-Life Data Support Reduced Sensitivity of Antigen Tests for Omicron SARS-CoV-2 Infections
Author
Piubelli, Chiara 1   VIAFID ORCID Logo  ; Treggiari, Davide 1 ; Lavezzari, Denise 1   VIAFID ORCID Logo  ; Deiana, Michela 1   VIAFID ORCID Logo  ; Dishnica, Klevia 2 ; Sole Tosato, Emma Maria 2 ; Mazzi, Cristina 3   VIAFID ORCID Logo  ; Cattaneo, Paolo 1   VIAFID ORCID Logo  ; Mori, Antonio 1 ; Pomari, Elena 1   VIAFID ORCID Logo  ; Nicolini, Lavinia 1 ; Leonardi, Martina 1 ; Perandin, Francesca 1   VIAFID ORCID Logo  ; Formenti, Fabio 1   VIAFID ORCID Logo  ; Giorgetti, Alejandro 2   VIAFID ORCID Logo  ; Conti, Antonio 4 ; Capobianchi, Maria Rosaria 1 ; Gobbi, Federico Giovanni 1 ; Castilletti, Concetta 1   VIAFID ORCID Logo 

 Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy[email protected] (L.N.); 
 Department of Biotechnology, University of Verona, 37124 Verona, Italy 
 Centre for Clinical Research, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy; [email protected] 
 Clinical Analysis Laboratory and Transfusional Service, IRCCS Sacro Cuore—Don Calabria Hospital, Negrar di Valpolicella, 37124 Verona, Italy 
First page
657
Publication year
2024
Publication date
2024
Publisher
MDPI AG
e-ISSN
19994915
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3059794666
Copyright
© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.