Author | Bagno, Flávia Fonseca | |
Author | Sérgio, Sarah Aparecida Rodrigues | |
Author | Figueiredo, Maria Marta | |
Author | Godoi, Lara Carvalho | |
Author | Andrade, Luis Adan Flores | |
Author | Castro, Natália Salazar de | |
Author | Soares, Camila Pereira | |
Author | Aguiar, Andressa | |
Author | Almeida, Flávia Jaqueline | |
Author | Silva, Edimilson D da | |
Author | Ferreira, Antônio G P | |
Author | Durigon, Edison Luiz | |
Author | Gazzinelli, Ricardo Tostes | |
Author | Teixeira, Santuza Maria Ribeiro | |
Author | Fernandes, Ana Paula Salles Moura | |
Author | Fonseca, Flavio Guimarães da | |
Access date | 2023-02-01T13:35:25Z | |
Available date | 2023-02-01T13:35:25Z | |
Document date | 2022 | |
Citation | BAGNO, Flávia Fonseca et al. Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19. J Clin Virol Plus, v. 2, n. 3, 100101, 2022. doi: 10.1016/j.jcvp.2022.100101. | en_US |
ISSN | 2667-0380 | en_US |
URI | https://www.arca.fiocruz.br/handle/icict/56800 | |
Language | eng | en_US |
Publisher | Elsevier Ltd. | en_US |
Rights | open access | en_US |
Title | Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19 | en_US |
Type | Article | en_US |
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. | en_US |
Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil/Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil | en_US |
Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil/Universidade Estadual de Minas Gerais. Divinópolis, MG, Brazil. | en_US |
Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil | en_US |
Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil | en_US |
Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil | en_US |
Affilliation | Universidade de São Paulo. Instituto de Ciências Biomédicas. São Paulo, SP, Brazil. | en_US |
Affilliation | Geriatric and Convalescent Hospital Dom Pedro II. São Paulo, SP, Brazil. | en_US |
Affilliation | Department of Pediatrics. Santa Casa de São Paulo School of Medical Sciences. São Paulo, SP, Brazil. | en_US |
Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brazil. | en_US |
Affilliation | Universidade de São Paulo. Instituto de Ciências Biomédicas. São Paulo, SP, Brazil. | en_US |
Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil/Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil. | en_US |
Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil/ Universidade Federal de Minas Gerais, Depto de Bioquímica e Imunologia, Belo Horizonte, MG, Brazil. | en_US |
Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil/Universidade Federal de Minas Gerais. Faculdade de Farmácia. Belo Horizonte, MG, Brazil. | en_US |
Affilliation | Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brasil/Universidade Federal de Minas Gerais. Instituto de Ciências Biológicas. Departamento de Microbiologia. Belo Horizonte, MG, Brazil. | en_US |
Subject | COVID-19 | en_US |
Subject | Diagnosis | en_US |
Subject | ELISA | en_US |
Subject | Prototyping | en_US |
Subject | SARS-CoV-2 | en_US |
Subject | Serological assay | en_US |