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Performance of VIDAS® Diagnostic Tests for the Automated Detection of Dengue Virus NS1 Antigen and of Anti-Dengue Virus IgM and IgG Antibodies: A Multicentre, International Study.
Versiani, Alice F; Kaboré, Antoinette; Brossault, Ludovic; Dromenq, Loïc; Dos Santos, Thayza M I L; Milhim, Bruno H G A; Estofolete, Cássia F; Cissé, Assana; Sorgho, Pegdwendé Abel; Senot, Florence; Tessonneau, Marie; Diagbouga, Serge; Nogueira, Mauricio L.
Afiliação
  • Versiani AF; Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto 15090-000, SP, Brazil.
  • Kaboré A; Institut de Recherche en Sciences de la Santé (IRSS), Centre MURAZ, Bobo-Dioulasso 01 BP 390, Burkina Faso.
  • Brossault L; BioMérieux SA, 69280 Marcy-l'Étoile, France.
  • Dromenq L; BioMérieux SA, 69280 Marcy-l'Étoile, France.
  • Dos Santos TMIL; Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto 15090-000, SP, Brazil.
  • Milhim BHGA; Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto 15090-000, SP, Brazil.
  • Estofolete CF; Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto 15090-000, SP, Brazil.
  • Cissé A; Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou 03 BP 7192, Burkina Faso.
  • Sorgho PA; Laboratory of Molecular and Genetic Biology (LABIOGENE), Joseph KI-ZERBO University, Pietro Annigoni Biomolecular Research Center (CERBA), Ouagadougou 01 BP 364, Burkina Faso.
  • Senot F; BioMérieux SA, 69280 Marcy-l'Étoile, France.
  • Tessonneau M; BioMérieux SA, 69280 Marcy-l'Étoile, France.
  • Diagbouga S; Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou 03 BP 7192, Burkina Faso.
  • Nogueira ML; Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto 15090-000, SP, Brazil.
Diagnostics (Basel) ; 13(6)2023 Mar 16.
Article em En | MEDLINE | ID: mdl-36980445
Dengue is a serious mosquito-transmitted disease caused by the dengue virus (DENV). Rapid and reliable diagnosis of DENV infection is urgently needed in dengue-endemic regions. We describe here the performance evaluation of the CE-marked VIDAS® dengue immunoassays developed for the automated detection of DENV NS1 antigen and anti-DENV IgM and IgG antibodies. A multicenter concordance study was conducted in 1296 patients from dengue-endemic regions in Asia, Latin America, and Africa. VIDAS® dengue results were compared to those of competitor enzyme-linked immunosorbent assays (ELISA). The VIDAS® dengue assays showed high precision (CV ≤ 10.7%) and limited cross-reactivity (≤15.4%) with other infections. VIDAS® DENGUE NS1 Ag showed high positive and negative percent agreement (92.8% PPA and 91.7% NPA) in acute patients within 0-5 days of symptom onset. VIDAS® Anti-DENGUE IgM and IgG showed a moderate-to-high concordance with ELISA (74.8% to 90.6%) in post-acute and recovery patients. PPA was further improved in combined VIDAS® NS1/IgM (96.4% in 0-5 days acute patients) and IgM/IgG (91.9% in post-acute patients) tests. Altogether, the VIDAS® dengue NS1, IgM, and IgG assays performed well, either alone or in combination, and should be suitable for the accurate diagnosis of DENV infection in dengue-endemic regions.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Diagnostic_studies Idioma: En Revista: Diagnostics (Basel) Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Brasil País de publicação: Suíça

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Diagnostic_studies Idioma: En Revista: Diagnostics (Basel) Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Brasil País de publicação: Suíça