Preprint Communication Version 1 Preserved in Portico This version is not peer-reviewed

Analytical Sensitivity of Five SARS-CoV-2 Rapid Antigen Tests for Omicron Versus Delta Variant

Jean-Louis Bayart
* ORCID logo ,
Jonathan Degosserie
ORCID logo ,
Julien Favresse
,
Constant Gillot
ORCID logo ,
Marie Didembourg
ORCID logo ,
Happy Phanio Djokoto
,
Valérie Verbelen
,
Gatien Roussel
,
Celine Maschietto
,
François Mullier
,
Jean-Michel Dogné
,
Jonathan Douxfils
ORCID logo
Version 1 : Received: 24 February 2022 / Approved: 1 March 2022 / Online: 1 March 2022 (09:01:19 CET)

A peer-reviewed article of this Preprint also exists.

Bayart, J.-L.; Degosserie, J.; Favresse, J.; Gillot, C.; Didembourg, M.; Djokoto, H.P.; Verbelen, V.; Roussel, G.; Maschietto, C.; Mullier, F.; Dogné, J.-M.; Douxfils, J. Analytical Sensitivity of Six SARS-CoV-2 Rapid Antigen Tests for Omicron Versus Delta Variant. Viruses 2022, 14, 654. Bayart, J.-L.; Degosserie, J.; Favresse, J.; Gillot, C.; Didembourg, M.; Djokoto, H.P.; Verbelen, V.; Roussel, G.; Maschietto, C.; Mullier, F.; Dogné, J.-M.; Douxfils, J. Analytical Sensitivity of Six SARS-CoV-2 Rapid Antigen Tests for Omicron Versus Delta Variant. Viruses 2022, 14, 654.

Abstract

Rapid antigen detection tests (RAD) are commonly used for the diagnosis of SARS-CoV-2 infections. However, with the continuous emergence of new variants of concern (VOC) presenting various mutations potentially affecting the nucleocapsid protein, the analytical performances of these assays should be frequently reevaluated. One-hundred and twenty samples were selected and tested with both RT-qPCR and five commercial RAD commonly sold in Belgian pharmacies. Of these, direct whole genome sequencing identified the strains present in 116 samples, of which 70 were Delta and 46 were Omicron. Sensitivity across a wide range of Ct values (13.5 to 35.7; median = 21.3) were comparable and ranged from 70.0% to 77.1% for Delta strains and from 69.6% to 78.3% for Omicron strains. When taking swabs with a low viral load (Ct > 25), poor performances were observed for the Delta strains (20.0 to 40.0%) and, even more so, for Omicron strains (0.0 to 23.1%). Two devices failed to detect all samples (n = 13) containing Omicron strains with a low viral load. The poor performance observed with low viral loads is an important limitation of RAD, which is not sufficiently highlighted in the instruction for use of these devices.

Keywords

SARS-CoV-2; variant; Omicron; Delta; antigen; RT-qPCR

Subject

Biology and Life Sciences, Virology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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