Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19

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Artigo de periódico

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Membros da banca

Resumo

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.

Abstract

Assunto

SARS-CoV-2, COVID-19, Diagnóstico, Sorologia, Ensaio de imunoadsorção enzimática

Palavras-chave

SARS-CoV-2, COVID-19, Diagnosis, Serological assay, ELISA, Prototyping

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Endereço externo

https://www.sciencedirect.com/science/article/pii/S2667038022000400?via%3Dihub

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