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. 2022 Aug 17:100103.
doi: 10.1016/j.jcvp.2022.100103. Online ahead of print.

DEVELOPMENT AND VALIDATION OF AN ENZYME-LINKED IMMUNOASSAY KIT FOR DIAGNOSIS AND SURVEILLANCE OF COVID-19

Flávia F Bagno  1   2 , Sarah A R Sérgio  1 , Maria Marta Figueiredo  1   3 , Lara C Godoi  1 , Luis A F Andrade  1 , Natália C Salazar  1 , Camila P Soares  4 , Andressa Aguiar  5 , Flávia Jaqueline Almeida  6 , Edimilson D da Silva  2 , Antônio G P Ferreira  2 , Edison Luiz Durigon  4 , Ricardo T Gazzinelli  1   7 , Santuza M R Teixeira  1   8 , Ana Paula S M Fernandes  1   9 , Flavio G da Fonseca  1   10
Affiliations

DEVELOPMENT AND VALIDATION OF AN ENZYME-LINKED IMMUNOASSAY KIT FOR DIAGNOSIS AND SURVEILLANCE OF COVID-19

Flávia F Bagno et al. J Clin Virol Plus. .

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.

Keywords: COVID-19; ELISA; SARS-CoV-2; diagnosis; prototyping; serological assay.

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Conflict of interest statement

The authors declare no conflict of interest. Funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

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