Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study

Detalhes bibliográficos
Autor(a) principal: Pereira, Geovana M.
Data de Publicação: 2023
Outros Autores: Manuli, Erika R., Coulon, Laurie, Côrtes, Marina F., Ramundo, Mariana S., Dromenq, Loïc, Larue-Triolet, Audrey, Raymond, Frédérique, Tourneur, Carole, Lázari, Carolina dos Santos, Brasil, Patricia, Filippis, Ana Maria Bispo de, Paranhos-Baccalà, Glaucia, Banz, Alice, Sabino, Ester C.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/60706
Resumo: Institutional Review Board Statement: The study was conducted in accordance with the Declaration of Helsinki, and approved by institutional ethics committee (CEP) of the Faculty of Medicine of the University of São Paulo, Brazil (approval number 4.692.542, dated 5 May 2021), and by the independent ethics committee Namaste Integrated Services, Lanka, Varanasi, India (approval number BS-IND-001, dated 7 August 2021).
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spelling Pereira, Geovana M.Manuli, Erika R.Coulon, LaurieCôrtes, Marina F.Ramundo, Mariana S.Dromenq, LoïcLarue-Triolet, AudreyRaymond, FrédériqueTourneur, CaroleLázari, Carolina dos SantosBrasil, PatriciaFilippis, Ana Maria Bispo deParanhos-Baccalà, GlauciaBanz, AliceSabino, Ester C.2023-10-05T00:02:37Z2023-10-05T00:02:37Z2023PEREIRA, Geovana M. et al. Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study. Diagnostics (Basel, Switzerland), v. 13, p. 1-19, Jul. 2023.2075-4418https://www.arca.fiocruz.br/handle/icict/6070610.3390/diagnostics131323062075-4418Institutional Review Board Statement: The study was conducted in accordance with the Declaration of Helsinki, and approved by institutional ethics committee (CEP) of the Faculty of Medicine of the University of São Paulo, Brazil (approval number 4.692.542, dated 5 May 2021), and by the independent ethics committee Namaste Integrated Services, Lanka, Varanasi, India (approval number BS-IND-001, dated 7 August 2021).This study was funded by bioMérieux and received no external funding. The APC was funded by bioMérieux.Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brazil.Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brazil / Universidade Municipal de São Caetano do Sul. Faculdade de Medicina. São Paulo, SP, Brazil / Universidade de São Paulo. Faculdade de Medicina. Hospital das Clínicas. Laboratório de Investigação Médica/Parasitologia LIM/46. São Paulo, SP, Brazil.BioMérieux. Marcy l'Etoile, France.Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brazil.Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brazil.BioMérieux. Marcy l'Etoile, France.BioMérieux. Marcy l'Etoile, France.BioMérieux. Marcy l'Etoile, France.BioMérieux. Marcy l'Etoile, France.Universidade de São Paulo. Faculdade de Medicina. Hospital das Clínicas. São Paulo, SP, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Arbovírus e Vírus Hemorrágicos. Rio de Janeiro, RJ, Brazil.Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brazil / BioMérieux. Marcy l'Etoile, France.BioMérieux. Marcy l'Etoile, France.Universidade de São Paulo. Faculdade de Medicina. Instituto de Medicina Tropical. São Paulo, SP, Brazil / Universidade Municipal de São Caetano do Sul. Faculdade de Medicina. São Paulo, SP, Brazil / Universidade de São Paulo. Faculdade de Medicina. Hospital das Clínicas. Laboratório de Investigação Médica/Parasitologia LIM/46. São Paulo, SP, Brazil.Chikungunya (CHIK) is a debilitating mosquito-borne disease with an epidemiology and early clinical symptoms similar to those of other arboviruses-triggered diseases such as dengue or Zika. Accurate and rapid diagnosis of CHIK virus (CHIKV) infection is therefore challenging. This international study evaluated the performance of the automated VIDAS® anti-CHIKV IgM and IgG assays compared to that of manual competitor IgM and IgG ELISA for the detection of anti-CHIKV IgM and IgG antibodies in 660 patients with suspected CHIKV infection. Positive and negative agreements of the VIDAS® CHIKV assays with ELISA ranged from 97.5% to 100.0%. The sensitivity of the VIDAS® CHIKV assays evaluated in patients with a proven CHIKV infection confirmed reported kinetics of anti-CHIKV IgM and IgG response, with a positive detection of 88.2-100.0% for IgM ≥ 5 days post symptom onset and of 100.0% for IgG ≥ 11 days post symptom onset. Our study also demonstrated the superiority of ELISA and VIDAS® assays over rapid diagnostic IgM/IgG tests. The analytical performance of VIDAS® anti-CHIKV IgM and IgG assays was excellent, with a high precision (coefficients of variation ≤ 7.4%) and high specificity (cross-reactivity rate ≤ 2.9%). This study demonstrates the suitability of the automated VIDAS® anti-CHIKV IgM and IgG assays to diagnose CHIKV infections and supports its applicability for epidemiological surveillance and differential diagnosis in regions endemic for CHIKV.engMDPIPerformance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Studyinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleCHIKVELFAELISAIgGIgMVIDAS®Capture immunoassayChikungunya virusEnzyme-linked fluorescent assayEnzyme-linked immunosorbent assayinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZORIGINALve_Geovana_Pereira_etal_IOC_INI_2023.pdfve_Geovana_Pereira_etal_IOC_INI_2023.pdfapplication/pdf1308730https://www.arca.fiocruz.br/bitstream/icict/60706/2/ve_Geovana_Pereira_etal_IOC_INI_2023.pdfaaa51a35fa10701866f9803a8706fe36MD52LICENSElicense.txtlicense.txttext/plain; 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dc.title.en_US.fl_str_mv Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study
title Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study
spellingShingle Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study
Pereira, Geovana M.
CHIKV
ELFA
ELISA
IgG
IgM
VIDAS®
Capture immunoassay
Chikungunya virus
Enzyme-linked fluorescent assay
Enzyme-linked immunosorbent assay
title_short Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study
title_full Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study
title_fullStr Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study
title_full_unstemmed Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study
title_sort Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study
author Pereira, Geovana M.
author_facet Pereira, Geovana M.
Manuli, Erika R.
Coulon, Laurie
Côrtes, Marina F.
Ramundo, Mariana S.
Dromenq, Loïc
Larue-Triolet, Audrey
Raymond, Frédérique
Tourneur, Carole
Lázari, Carolina dos Santos
Brasil, Patricia
Filippis, Ana Maria Bispo de
Paranhos-Baccalà, Glaucia
Banz, Alice
Sabino, Ester C.
author_role author
author2 Manuli, Erika R.
Coulon, Laurie
Côrtes, Marina F.
Ramundo, Mariana S.
Dromenq, Loïc
Larue-Triolet, Audrey
Raymond, Frédérique
Tourneur, Carole
Lázari, Carolina dos Santos
Brasil, Patricia
Filippis, Ana Maria Bispo de
Paranhos-Baccalà, Glaucia
Banz, Alice
Sabino, Ester C.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Pereira, Geovana M.
Manuli, Erika R.
Coulon, Laurie
Côrtes, Marina F.
Ramundo, Mariana S.
Dromenq, Loïc
Larue-Triolet, Audrey
Raymond, Frédérique
Tourneur, Carole
Lázari, Carolina dos Santos
Brasil, Patricia
Filippis, Ana Maria Bispo de
Paranhos-Baccalà, Glaucia
Banz, Alice
Sabino, Ester C.
dc.subject.en.en_US.fl_str_mv CHIKV
ELFA
ELISA
IgG
IgM
VIDAS®
Capture immunoassay
Chikungunya virus
Enzyme-linked fluorescent assay
Enzyme-linked immunosorbent assay
topic CHIKV
ELFA
ELISA
IgG
IgM
VIDAS®
Capture immunoassay
Chikungunya virus
Enzyme-linked fluorescent assay
Enzyme-linked immunosorbent assay
description Institutional Review Board Statement: The study was conducted in accordance with the Declaration of Helsinki, and approved by institutional ethics committee (CEP) of the Faculty of Medicine of the University of São Paulo, Brazil (approval number 4.692.542, dated 5 May 2021), and by the independent ethics committee Namaste Integrated Services, Lanka, Varanasi, India (approval number BS-IND-001, dated 7 August 2021).
publishDate 2023
dc.date.accessioned.fl_str_mv 2023-10-05T00:02:37Z
dc.date.available.fl_str_mv 2023-10-05T00:02:37Z
dc.date.issued.fl_str_mv 2023
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 PEREIRA, Geovana M. et al. Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study. Diagnostics (Basel, Switzerland), v. 13, p. 1-19, Jul. 2023.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/60706
dc.identifier.issn.en_US.fl_str_mv 2075-4418
dc.identifier.doi.none.fl_str_mv 10.3390/diagnostics13132306
dc.identifier.eissn.none.fl_str_mv 2075-4418
identifier_str_mv PEREIRA, Geovana M. et al. Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study. Diagnostics (Basel, Switzerland), v. 13, p. 1-19, Jul. 2023.
2075-4418
10.3390/diagnostics13132306
url https://www.arca.fiocruz.br/handle/icict/60706
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 MDPI
publisher.none.fl_str_mv MDPI
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/60706/2/ve_Geovana_Pereira_etal_IOC_INI_2023.pdf
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