Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 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.

PubMed Disclaimer

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.