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

Detalhes bibliográficos
Autor(a) principal: Bagno, Flávia Fonseca
Data de Publicação: 2022
Outros Autores: Sérgio, Sarah Aparecida Rodrigues, Figueiredo, Maria Marta, Godoi, Lara Carvalho, Andrade, Luis Adan Flores, Castro, Natália Salazar de, Soares, Camila Pereira, Aguiar, Andressa, Almeida, Flávia Jaqueline, Silva, Edimilson D da, Ferreira, Antônio G P, Durigon, Edison Luiz, Gazzinelli, Ricardo Tostes, Teixeira, Santuza Maria Ribeiro, Fernandes, Ana Paula Salles Moura, Fonseca, Flavio Guimarães da
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/56800
Resumo: 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.
id CRUZ_7ce976274ed92c119d458ece4babe5a3
oai_identifier_str oai:www.arca.fiocruz.br:icict/56800
network_acronym_str CRUZ
network_name_str Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str 2135
spelling Bagno, Flávia FonsecaSérgio, Sarah Aparecida RodriguesFigueiredo, Maria MartaGodoi, Lara CarvalhoAndrade, Luis Adan FloresCastro, Natália Salazar deSoares, Camila PereiraAguiar, AndressaAlmeida, Flávia JaquelineSilva, Edimilson D daFerreira, Antônio G PDurigon, Edison LuizGazzinelli, Ricardo TostesTeixeira, Santuza Maria RibeiroFernandes, Ana Paula Salles MouraFonseca, Flavio Guimarães da2023-02-01T13:35:25Z2023-02-01T13:35:25Z2022BAGNO, 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.2022.100101.2667-0380https://www.arca.fiocruz.br/handle/icict/56800engElsevier Ltd.Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleUniversidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil/Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brazil.Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, BrazilUniversidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil/Universidade Estadual de Minas Gerais. Divinópolis, MG, Brazil.Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, BrazilUniversidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, BrazilUniversidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, BrazilUniversidade de São Paulo. Instituto de Ciências Biomédicas. São Paulo, SP, Brazil.Geriatric and Convalescent Hospital Dom Pedro II. São Paulo, SP, Brazil.Department of Pediatrics. Santa Casa de São Paulo School of Medical Sciences. São Paulo, SP, Brazil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brazil.Universidade de São Paulo. Instituto de Ciências Biomédicas. São Paulo, SP, Brazil.Universidade Federal de Minas Gerais. Centro de Tecnologia de Vacinas. Belo Horizonte, MG, Brazil/Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil.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.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.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.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.COVID-19DiagnosisELISAPrototypingSARS-CoV-2Serological assayinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZORIGINALDevelopment and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19.pdfDevelopment and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19.pdfapplication/pdf929531https://www.arca.fiocruz.br/bitstream/icict/56800/2/Development%20and%20validation%20of%20an%20enzyme-linked%20immunoassay%20kit%20for%20diagnosis%20and%20surveillance%20of%20COVID-19.pdfa0a54948cb2eed01c3bf5090613a7402MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/56800/1/license.txt5a560609d32a3863062d77ff32785d58MD51icict/568002023-02-01 10:35:26.661oai:www.arca.fiocruz.br:icict/56800Q0VTU8ODTyBOw4NPIEVYQ0xVU0lWQSBERSBESVJFSVRPUyBBVVRPUkFJUwoKQW8gYWNlaXRhciBvcyBURVJNT1MgZSBDT05EScOHw5VFUyBkZXN0YSBDRVNTw4NPLCBvIEFVVE9SIGUvb3UgVElUVUxBUiBkZSBkaXJlaXRvcwphdXRvcmFpcyBzb2JyZSBhIE9CUkEgZGUgcXVlIHRyYXRhIGVzdGUgZG9jdW1lbnRvOgoKKDEpIENFREUgZSBUUkFOU0ZFUkUsIHRvdGFsIGUgZ3JhdHVpdGFtZW50ZSwgw6AgRklPQ1JVWiAtIEZVTkRBw4fDg08gT1NXQUxETyBDUlVaLCBlbQpjYXLDoXRlciBwZXJtYW5lbnRlLCBpcnJldm9nw6F2ZWwgZSBOw4NPIEVYQ0xVU0lWTywgdG9kb3Mgb3MgZGlyZWl0b3MgcGF0cmltb25pYWlzIE7Dg08KQ09NRVJDSUFJUyBkZSB1dGlsaXphw6fDo28gZGEgT0JSQSBhcnTDrXN0aWNhIGUvb3UgY2llbnTDrWZpY2EgaW5kaWNhZGEgYWNpbWEsIGluY2x1c2l2ZSBvcyBkaXJlaXRvcwpkZSB2b3ogZSBpbWFnZW0gdmluY3VsYWRvcyDDoCBPQlJBLCBkdXJhbnRlIHRvZG8gbyBwcmF6byBkZSBkdXJhw6fDo28gZG9zIGRpcmVpdG9zIGF1dG9yYWlzLCBlbQpxdWFscXVlciBpZGlvbWEgZSBlbSB0b2RvcyBvcyBwYcOtc2VzOwoKKDIpIEFDRUlUQSBxdWUgYSBjZXNzw6NvIHRvdGFsIG7Do28gZXhjbHVzaXZhLCBwZXJtYW5lbnRlIGUgaXJyZXZvZ8OhdmVsIGRvcyBkaXJlaXRvcyBhdXRvcmFpcwpwYXRyaW1vbmlhaXMgbsOjbyBjb21lcmNpYWlzIGRlIHV0aWxpemHDp8OjbyBkZSBxdWUgdHJhdGEgZXN0ZSBkb2N1bWVudG8gaW5jbHVpLCBleGVtcGxpZmljYXRpdmFtZW50ZSwKb3MgZGlyZWl0b3MgZGUgZGlzcG9uaWJpbGl6YcOnw6NvIGUgY29tdW5pY2HDp8OjbyBww7pibGljYSBkYSBPQlJBLCBlbSBxdWFscXVlciBtZWlvIG91IHZlw61jdWxvLAppbmNsdXNpdmUgZW0gUmVwb3NpdMOzcmlvcyBEaWdpdGFpcywgYmVtIGNvbW8gb3MgZGlyZWl0b3MgZGUgcmVwcm9kdcOnw6NvLCBleGliacOnw6NvLCBleGVjdcOnw6NvLApkZWNsYW1hw6fDo28sIHJlY2l0YcOnw6NvLCBleHBvc2nDp8OjbywgYXJxdWl2YW1lbnRvLCBpbmNsdXPDo28gZW0gYmFuY28gZGUgZGFkb3MsIHByZXNlcnZhw6fDo28sIGRpZnVzw6NvLApkaXN0cmlidWnDp8OjbywgZGl2dWxnYcOnw6NvLCBlbXByw6lzdGltbywgdHJhZHXDp8OjbywgZHVibGFnZW0sIGxlZ2VuZGFnZW0sIGluY2x1c8OjbyBlbSBub3ZhcyBvYnJhcyBvdQpjb2xldMOibmVhcywgcmV1dGlsaXphw6fDo28sIGVkacOnw6NvLCBwcm9kdcOnw6NvIGRlIG1hdGVyaWFsIGRpZMOhdGljbyBlIGN1cnNvcyBvdSBxdWFscXVlciBmb3JtYSBkZQp1dGlsaXphw6fDo28gbsOjbyBjb21lcmNpYWw7CgooMykgUkVDT05IRUNFIHF1ZSBhIGNlc3PDo28gYXF1aSBlc3BlY2lmaWNhZGEgY29uY2VkZSDDoCBGSU9DUlVaIC0gRlVOREHDh8ODTyBPU1dBTERPCkNSVVogbyBkaXJlaXRvIGRlIGF1dG9yaXphciBxdWFscXVlciBwZXNzb2Eg4oCTIGbDrXNpY2Egb3UganVyw61kaWNhLCBww7pibGljYSBvdSBwcml2YWRhLCBuYWNpb25hbCBvdQplc3RyYW5nZWlyYSDigJMgYSBhY2Vzc2FyIGUgdXRpbGl6YXIgYW1wbGFtZW50ZSBhIE9CUkEsIHNlbSBleGNsdXNpdmlkYWRlLCBwYXJhIHF1YWlzcXVlcgpmaW5hbGlkYWRlcyBuw6NvIGNvbWVyY2lhaXM7CgooNCkgREVDTEFSQSBxdWUgYSBvYnJhIMOpIGNyaWHDp8OjbyBvcmlnaW5hbCBlIHF1ZSDDqSBvIHRpdHVsYXIgZG9zIGRpcmVpdG9zIGFxdWkgY2VkaWRvcyBlIGF1dG9yaXphZG9zLApyZXNwb25zYWJpbGl6YW5kby1zZSBpbnRlZ3JhbG1lbnRlIHBlbG8gY29udGXDumRvIGUgb3V0cm9zIGVsZW1lbnRvcyBxdWUgZmF6ZW0gcGFydGUgZGEgT0JSQSwKaW5jbHVzaXZlIG9zIGRpcmVpdG9zIGRlIHZveiBlIGltYWdlbSB2aW5jdWxhZG9zIMOgIE9CUkEsIG9icmlnYW5kby1zZSBhIGluZGVuaXphciB0ZXJjZWlyb3MgcG9yCmRhbm9zLCBiZW0gY29tbyBpbmRlbml6YXIgZSByZXNzYXJjaXIgYSBGSU9DUlVaIC0gRlVOREHDh8ODTyBPU1dBTERPIENSVVogZGUKZXZlbnR1YWlzIGRlc3Blc2FzIHF1ZSB2aWVyZW0gYSBzdXBvcnRhciwgZW0gcmF6w6NvIGRlIHF1YWxxdWVyIG9mZW5zYSBhIGRpcmVpdG9zIGF1dG9yYWlzIG91CmRpcmVpdG9zIGRlIHZveiBvdSBpbWFnZW0sIHByaW5jaXBhbG1lbnRlIG5vIHF1ZSBkaXogcmVzcGVpdG8gYSBwbMOhZ2lvIGUgdmlvbGHDp8O1ZXMgZGUgZGlyZWl0b3M7CgooNSkgQUZJUk1BIHF1ZSBjb25oZWNlIGEgUG9sw610aWNhIEluc3RpdHVjaW9uYWwgZGUgQWNlc3NvIEFiZXJ0byBkYSBGSU9DUlVaIC0gRlVOREHDh8ODTwpPU1dBTERPIENSVVogZSBhcyBkaXJldHJpemVzIHBhcmEgbyBmdW5jaW9uYW1lbnRvIGRvIHJlcG9zaXTDs3JpbyBpbnN0aXR1Y2lvbmFsIEFSQ0EuCgpBIFBvbMOtdGljYSBJbnN0aXR1Y2lvbmFsIGRlIEFjZXNzbyBBYmVydG8gZGEgRklPQ1JVWiAtIEZVTkRBw4fDg08gT1NXQUxETyBDUlVaIHJlc2VydmEKZXhjbHVzaXZhbWVudGUgYW8gQVVUT1Igb3MgZGlyZWl0b3MgbW9yYWlzIGUgb3MgdXNvcyBjb21lcmNpYWlzIHNvYnJlIGFzIG9icmFzIGRlIHN1YSBhdXRvcmlhCmUvb3UgdGl0dWxhcmlkYWRlLCBzZW5kbyBvcyB0ZXJjZWlyb3MgdXN1w6FyaW9zIHJlc3BvbnPDoXZlaXMgcGVsYSBhdHJpYnVpw6fDo28gZGUgYXV0b3JpYSBlIG1hbnV0ZW7Dp8OjbwpkYSBpbnRlZ3JpZGFkZSBkYSBPQlJBIGVtIHF1YWxxdWVyIHV0aWxpemHDp8Ojby4KCkEgUG9sw610aWNhIEluc3RpdHVjaW9uYWwgZGUgQWNlc3NvIEFiZXJ0byBkYSBGSU9DUlVaIC0gRlVOREHDh8ODTyBPU1dBTERPIENSVVoKcmVzcGVpdGEgb3MgY29udHJhdG9zIGUgYWNvcmRvcyBwcmVleGlzdGVudGVzIGRvcyBBdXRvcmVzIGNvbSB0ZXJjZWlyb3MsIGNhYmVuZG8gYW9zIEF1dG9yZXMKaW5mb3JtYXIgw6AgSW5zdGl0dWnDp8OjbyBhcyBjb25kacOnw7VlcyBlIG91dHJhcyByZXN0cmnDp8O1ZXMgaW1wb3N0YXMgcG9yIGVzdGVzIGluc3RydW1lbnRvcy4KRepositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-02-01T13:35:26Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.en_US.fl_str_mv Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19
title Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19
spellingShingle Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19
Bagno, Flávia Fonseca
COVID-19
Diagnosis
ELISA
Prototyping
SARS-CoV-2
Serological assay
title_short Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19
title_full Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19
title_fullStr Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19
title_full_unstemmed Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19
title_sort Development and validation of an enzyme-linked immunoassay kit for diagnosis and surveillance of COVID-19
author Bagno, Flávia Fonseca
author_facet Bagno, Flávia Fonseca
Sérgio, Sarah Aparecida Rodrigues
Figueiredo, Maria Marta
Godoi, Lara Carvalho
Andrade, Luis Adan Flores
Castro, Natália Salazar de
Soares, Camila Pereira
Aguiar, Andressa
Almeida, Flávia Jaqueline
Silva, Edimilson D da
Ferreira, Antônio G P
Durigon, Edison Luiz
Gazzinelli, Ricardo Tostes
Teixeira, Santuza Maria Ribeiro
Fernandes, Ana Paula Salles Moura
Fonseca, Flavio Guimarães da
author_role author
author2 Sérgio, Sarah Aparecida Rodrigues
Figueiredo, Maria Marta
Godoi, Lara Carvalho
Andrade, Luis Adan Flores
Castro, Natália Salazar de
Soares, Camila Pereira
Aguiar, Andressa
Almeida, Flávia Jaqueline
Silva, Edimilson D da
Ferreira, Antônio G P
Durigon, Edison Luiz
Gazzinelli, Ricardo Tostes
Teixeira, Santuza Maria Ribeiro
Fernandes, Ana Paula Salles Moura
Fonseca, Flavio Guimarães da
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Bagno, Flávia Fonseca
Sérgio, Sarah Aparecida Rodrigues
Figueiredo, Maria Marta
Godoi, Lara Carvalho
Andrade, Luis Adan Flores
Castro, Natália Salazar de
Soares, Camila Pereira
Aguiar, Andressa
Almeida, Flávia Jaqueline
Silva, Edimilson D da
Ferreira, Antônio G P
Durigon, Edison Luiz
Gazzinelli, Ricardo Tostes
Teixeira, Santuza Maria Ribeiro
Fernandes, Ana Paula Salles Moura
Fonseca, Flavio Guimarães da
dc.subject.en.en_US.fl_str_mv COVID-19
Diagnosis
ELISA
Prototyping
SARS-CoV-2
Serological assay
topic COVID-19
Diagnosis
ELISA
Prototyping
SARS-CoV-2
Serological assay
description 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.
publishDate 2022
dc.date.issued.fl_str_mv 2022
dc.date.accessioned.fl_str_mv 2023-02-01T13:35:25Z
dc.date.available.fl_str_mv 2023-02-01T13:35:25Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv 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.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/56800
dc.identifier.issn.en_US.fl_str_mv 2667-0380
identifier_str_mv 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.
2667-0380
url https://www.arca.fiocruz.br/handle/icict/56800
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier Ltd.
publisher.none.fl_str_mv Elsevier Ltd.
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/56800/2/Development%20and%20validation%20of%20an%20enzyme-linked%20immunoassay%20kit%20for%20diagnosis%20and%20surveillance%20of%20COVID-19.pdf
https://www.arca.fiocruz.br/bitstream/icict/56800/1/license.txt
bitstream.checksum.fl_str_mv a0a54948cb2eed01c3bf5090613a7402
5a560609d32a3863062d77ff32785d58
bitstream.checksumAlgorithm.fl_str_mv MD5
MD5
repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
_version_ 1822792022595993600