Flávia F Bagno, Sarah A R Sérgio, Maria Marta Figueiredo, Lara C Godoi, Luis A F Andrade, Natália C Salazar, Camila P Soares, Andressa Aguiar, Flávia Jaqueline Almeida, Edimilson D da Silva, Antônio G P Ferreira, Edison Luiz Durigon, Ricardo T Gazzinelli, Santuza M R Teixeira, Ana Paula S M Fernandes, Flavio G da Fonseca
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DEVELOPMENT AND VALIDATION OF AN ENZYME-LINKED IMMUNOASSAY KIT FOR DIAGNOSIS AND SURVEILLANCE OF COVID-19.
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.
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