학술논문
SARS-CoV-2 Rapid Antigen Test Based on a New Anti-Nucleocapsid Protein Monoclonal Antibody: Development and Real-Time Validation
Document Type
article
Author
Fabiana Fioravante Coelho; Miriam Aparecida da Silva; Thiciany Blener Lopes; Juliana Moutinho Polatto; Natália Salazar de Castro; Luis Adan Flores Andrade; Karine Lima Lourenço; Hugo Itaru Sato; Alex Fiorini de Carvalho; Helena Perez Coelho; Flávia Fonseca Bagno; Daniela Luz; Vincent Louis Viala; Pedro Queiroz Cattony; Bruna de Sousa Melo; Ana Maria Moro; Wagner Quintilio; Ana Paula Barbosa; Camila Gasque Bomfim; Camila Pereira Soares; Cristiane Rodrigues Guzzo; Flavio Guimarães Fonseca; Edison Luiz Durigon; Ricardo Tostes Gazzinelli; Santuza M. Ribeiro Teixeira; Roxane Maria Fontes Piazza; Ana Paula Fernandes
Source
Microorganisms, Vol 11, Iss 10, p 2422 (2023)
Subject
Language
English
ISSN
2076-2607
Abstract
SARS-CoV-2 diagnostic tests have become an important tool for pandemic control. Among the alternatives for COVID-19 diagnosis, antigen rapid diagnostic tests (Ag-RDT) are very convenient and widely used. However, as SARS-CoV-2 variants may continuously emerge, the replacement of tests and reagents may be required to maintain the sensitivity of Ag-RDTs. Here, we describe the development and validation of an Ag-RDT during an outbreak of the Omicron variant, including the characterization of a new monoclonal antibody (anti-DTC-N 1B3 mAb) that recognizes the Nucleocapsid protein (N). The anti-DTC-N 1B3 mAb recognized the sequence TFPPTEPKKDKKK located at the C-terminus of the N protein of main SARS-CoV-2 variants of concern. Accordingly, the Ag-RDT prototypes using the anti-DTC-N 1B3 mAB detected all the SARS-CoV-2 variants—Wuhan, Alpha, Gamma, Delta, P2 and Omicron. The performance of the best prototype (sensitivity of 95.2% for samples with Ct ≤ 25; specificity of 98.3% and overall accuracy of 85.0%) met the WHO recommendations. Moreover, results from a patients’ follow-up study indicated that, if performed within the first three days after onset of symptoms, the Ag-RDT displayed 100% sensitivity. Thus, the new mAb and the Ag-RDT developed herein may constitute alternative tools for COVID-19 point-of-care diagnosis and epidemiological surveillance.