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PERFORMANCE EVALUATION OF VIDAS® DIAGNOSTIC ASSAYS DETECTING ANTI-CHIKUNGUNYA VIRUS IGM AND IGG ANTIBODIES: AN INTERNATIONAL STUDY
Pereira, Geovana M. et al. | Date Issued: 2023
Author
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.
Affilliation
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.
Abstract
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.
Keywords
CHIKV
ELFA
ELISA
IgG
IgM
VIDAS®
Capture immunoassay
Chikungunya virus
Enzyme-linked fluorescent assay
Enzyme-linked immunosorbent assay
 
Publisher
MDPI
Citation
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.
DOI
10.3390/diagnostics13132306
ISSN
2075-4418
Notes
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).