Development and Validation of an Enzyme-linked Immunoassay Kit for Diagnosis and Surveillance of COVID-19

Overview

Journal J Clin Virol Plus

Specialty Microbiology

Date 2022 Aug 12

PMID 35959109

Authors

Flavia F Bagno

Sarah A R Sergio

Maria Marta Figueiredo

Lara C Godoi

Luis A F Andrade

Natalia C Salazar

Camila P Soares

Andressa Aguiar

Flavia Jaqueline Almeida

Edimilson D da Silva

Antonio G P Ferreira

Edison Luiz Durigon

Ricardo T Gazzinelli

Santuza M R Teixeira

Ana Paula S M Fernandes

Flavio G Da Fonseca

Affiliations

Soon will be listed here.

Abstract

There is a massive demand to identify alternative methods to detect new cases of COVID-19 as well as to investigate the epidemiology of the disease. In many countries, importation of commercial kits poses a significant impact on their testing capacity and increases the costs for the public health system. We have developed an ELISA to detect IgG antibodies against SARS-CoV-2 using a recombinant viral nucleocapsid (rN) protein expressed in . Using a total of 894 clinical samples we showed that the rN-ELISA was able to detect IgG antibodies against SARS-CoV-2 with high sensitivity (97.5%) and specificity (96.3%) when compared to a commercial antibody test. After three external validation studies, we showed that the test accuracy was higher than 90%. The rN-ELISA IgG kit constitutes a convenient and specific method for the large-scale determination of SARS-CoV-2 antibodies in human sera with high reliability.

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