Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19
Flávia Fonseca Bagno, Sarah Aparecida Rodrigues Sérgio, Maria Marta Figueiredo, Lara Carvalho Godói, Luis Adan Flores Andrade, Natália C. Salazar, Camila Pereira Soares, Andressa Aguiar, Flávia Jacqueline Almeida, Edimilson D. da Silva, Antonio Ferreira, Edison Luíz Durigon, Ricardo T. Gazzinelli, Santuza Maria Ribeiro Teixeira, Ana Paula Fernandes, Flávio Guimarães da Fonseca
Abstract
. 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.