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

Autor:	Bagno FF; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.; Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil., Sérgio SAR; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil., Figueiredo MM; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.; Universidade Estadual de Minas Gerais, Divinópolis, MG, Brazil., Godoi LC; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil., Andrade LAF; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil., Salazar NC; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil., Soares CP; Universidade de São Paulo (USP), Instituto de Ciências Biomédicas, São Paulo, SP, Brazil., Aguiar A; Geriatric and Convalescent Hospital Dom Pedro II, São Paulo, SP, Brazil., Almeida FJ; Department of Pediatrics, Santa Casa de São Paulo School of Medical Sciences, São Paulo, SP, Brazil., da Silva ED; Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil., Ferreira AGP; Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil., Durigon EL; Universidade de São Paulo (USP), Instituto de Ciências Biomédicas, São Paulo, SP, Brazil., Gazzinelli RT; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.; Fundação Oswaldo Cruz-Fiocruz, Centro de Pesquisas René Rachou, Belo Horizonte, MG, Brazil., Teixeira SMR; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.; Universidade Federal de Minas Gerais, Depto de Bioquímica e Imunologia, Belo Horizonte, MG, Brazil., Fernandes APSM; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.; Universidade Federal de Minas Gerais, Faculdade de Farmácia, Belo Horizonte, MG, Brazil., da Fonseca FG; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.; Universidade Federal de Minas Gerais, Depto de Microbiologia, ICB/UFMG, Belo Horizonte, MG, Brazil.
Jazyk:	angličtina
Zdroj:	Journal of clinical virology plus [J Clin Virol Plus] 2022 Aug 17, pp. 100103. Date of Electronic Publication: 2022 Aug 17.
DOI:	10.1016/j.jcvp.2022.100103
Abstrakt:	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. Competing Interests: 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. (© 2022 The Author(s). Published by Elsevier Ltd.)
Databáze:	MEDLINE
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