1. Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19
- Author
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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, and Flavio G. da Fonseca
- Subjects
SARS-CoV-2 ,COVID-19 ,Diagnosis ,Serological assay ,ELISA ,Prototyping ,Infectious and parasitic diseases ,RC109-216 - 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 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.
- Published
- 2022
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