key: cord-0957446-cklvtbep
authors: Gandolfo, Claudia; Morecchiato, Fabio; Pistello, Mauro; Rossolini, Gian Maria; Cusi, Maria Grazia
title: Detection of SARS-CoV-2 N protein allelic variants by rapid high-throughput CLEIA antigen assay
date: 2021-08-08
journal: J Clin Virol
DOI: 10.1016/j.jcv.2021.104942
sha: 54de1fbe96b6725f28e66e24daff1232ca6244cb
doc_id: 957446
cord_uid: cklvtbep

nan

The spreading of SARS-CoV-2 genetic variants may pose challenges in the identification of new 10 positives. In particular, there are concerns with the possibility that SARS-CoV-2 genetic variants 11 could escape antigen detection tests, that are commercially available and widely used [1] . In a recent 12 report it is claimed that some rapid antigenic tests failed to identify rare SARS-CoV-2 variants 13 circulating in Veneto (a region of Italy) [2] . The Authors speculated that the undetected variants 14 contained mutations inside the major N antigen B cell epitope, which negatively affected the test 15 results. 16 Here, we report the data obtained using an automated chemiluminescence enzyme immunoassay 17 (CLEIA) for rapid antigen detection of SARS-CoV-2 (Lumipulse Fujirebio, Inc., Tokyo, Japan) with 18 a number of variants. The system can detect and quantitatively estimate the presence of SARS-CoV-19 2 nucleocapsid protein in nasopharyngeal swabs or saliva. (Table 1) . 34 The good performances of the test are evident and widely recognized [3-4]. Our experience therefore 35 confirmed that the CLEIA SARS-CoV-2 antigen assay used in this study, unlike many commercially for-profit sectors. 54 We declare no competing interests.

SARS-CoV-2 diagnostic pipeline

Emergence of N antigen SARS-COV-2 genetic

-2 antigen assay automated test for detecting SARS-CoV-2 nucleocapsid 64 protein (NP) in nasopharyngeal swabs for community and population screening

Epub ahead of print

Immunochromatography and chemiluminescent enzyme immunoassay for COVID-19 diagnosis