%0 Journal Article
%T Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19.
%A Bagno FF
%A Sérgio SAR
%A Figueiredo MM
%A Godoi LC
%A Andrade LAF
%A Salazar NC
%A Soares CP
%A Aguiar A
%A Almeida FJ
%A da Silva ED
%A Ferreira AGP
%A Durigon EL
%A Gazzinelli RT
%A Teixeira SMR
%A Fernandes APSM
%A da Fonseca FG
%A Bagno FF
%A Sérgio SAR
%A Figueiredo MM
%A Godoi LC
%A Andrade LAF
%A Salazar NC
%A Soares CP
%A Aguiar A
%A Almeida FJ
%A da Silva ED
%A Ferreira AGP
%A Durigon EL
%A Gazzinelli RT
%A Teixeira SMR
%A Fernandes APSM
%A da Fonseca FG
%J J Clin Virol Plus
%V 2
%N 3
%D Aug 2022
%M 35959109
暂无%R 10.1016/j.jcvp.2022.100101
%X 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 E. coli. 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.