Performance of VIDAS<sup>®</sup> Diagnostic Tests for the Automated Detection of Dengue Virus NS1 Antigen and of Anti-Dengue Virus IgM and IgG Antibodies: A Multicentre, International Study
Alice F. Versiani,
Antoinette Kaboré,
Ludovic Brossault,
Loïc Dromenq,
Thayza M. I. L. dos Santos,
Bruno H. G. A. Milhim,
Cássia F. Estofolete,
Assana Cissé,
Pegdwendé Abel Sorgho,
Florence Senot,
Marie Tessonneau,
Serge Diagbouga,
Mauricio L. Nogueira
Affiliations
Alice F. Versiani
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
Antoinette Kaboré
Institut de Recherche en Sciences de la Santé (IRSS), Centre MURAZ, Bobo-Dioulasso 01 BP 390, Burkina Faso
Ludovic Brossault
BioMérieux SA, 69280 Marcy-l’Étoile, France
Loïc Dromenq
BioMérieux SA, 69280 Marcy-l’Étoile, France
Thayza M. I. L. dos Santos
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
Bruno H. G. A. Milhim
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
Cássia F. Estofolete
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
Assana Cissé
Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou 03 BP 7192, Burkina Faso
Pegdwendé Abel Sorgho
Laboratory of Molecular and Genetic Biology (LABIOGENE), Joseph KI-ZERBO University, Pietro Annigoni Biomolecular Research Center (CERBA), Ouagadougou 01 BP 364, Burkina Faso
Florence Senot
BioMérieux SA, 69280 Marcy-l’Étoile, France
Marie Tessonneau
BioMérieux SA, 69280 Marcy-l’Étoile, France
Serge Diagbouga
Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou 03 BP 7192, Burkina Faso
Mauricio L. Nogueira
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
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.
