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
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<sup>®</sup> dengue immunoassays developed fo...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-03-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/13/6/1137 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Alice F. Versiani |
| collection | DOAJ |
| description | 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<sup>®</sup> 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<sup>®</sup> dengue results were compared to those of competitor enzyme-linked immunosorbent assays (ELISA). The VIDAS<sup>®</sup> dengue assays showed high precision (CV ≤ 10.7%) and limited cross-reactivity (≤15.4%) with other infections. VIDAS<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> NS1/IgM (96.4% in 0–5 days acute patients) and IgM/IgG (91.9% in post-acute patients) tests. Altogether, the VIDAS<sup>®</sup> 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. |
| first_indexed | 2024-03-11T06:40:45Z |
| format | Article |
| id | doaj.art-511d174f9d5e4dd081666db5267d221b |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-11T06:40:45Z |
| publishDate | 2023-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-511d174f9d5e4dd081666db5267d221b2023-11-17T10:34:51ZengMDPI AGDiagnostics2075-44182023-03-01136113710.3390/diagnostics13061137Performance 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 StudyAlice F. Versiani0Antoinette Kaboré1Ludovic Brossault2Loïc Dromenq3Thayza M. I. L. dos Santos4Bruno H. G. A. Milhim5Cássia F. Estofolete6Assana Cissé7Pegdwendé Abel Sorgho8Florence Senot9Marie Tessonneau10Serge Diagbouga11Mauricio L. Nogueira12Departamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto 15090-000, SP, BrazilInstitut de Recherche en Sciences de la Santé (IRSS), Centre MURAZ, Bobo-Dioulasso 01 BP 390, Burkina FasoBioMérieux SA, 69280 Marcy-l’Étoile, FranceBioMérieux SA, 69280 Marcy-l’Étoile, FranceDepartamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto 15090-000, SP, BrazilDepartamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto 15090-000, SP, BrazilDepartamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto 15090-000, SP, BrazilInstitut de Recherche en Sciences de la Santé (IRSS), Ouagadougou 03 BP 7192, Burkina FasoLaboratory of Molecular and Genetic Biology (LABIOGENE), Joseph KI-ZERBO University, Pietro Annigoni Biomolecular Research Center (CERBA), Ouagadougou 01 BP 364, Burkina FasoBioMérieux SA, 69280 Marcy-l’Étoile, FranceBioMérieux SA, 69280 Marcy-l’Étoile, FranceInstitut de Recherche en Sciences de la Santé (IRSS), Ouagadougou 03 BP 7192, Burkina FasoDepartamento de Doenças Infecciosas e Parasitárias, Faculdade de Medicina de São José do Rio Preto (FAMERP), São José do Rio Preto 15090-000, SP, BrazilDengue 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<sup>®</sup> 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<sup>®</sup> dengue results were compared to those of competitor enzyme-linked immunosorbent assays (ELISA). The VIDAS<sup>®</sup> dengue assays showed high precision (CV ≤ 10.7%) and limited cross-reactivity (≤15.4%) with other infections. VIDAS<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> NS1/IgM (96.4% in 0–5 days acute patients) and IgM/IgG (91.9% in post-acute patients) tests. Altogether, the VIDAS<sup>®</sup> 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.https://www.mdpi.com/2075-4418/13/6/1137dengue diagnosisDENVNS1 antigenIgM and IgG antibodiesELISAVIDAS<sup>®</sup> |
| spellingShingle | 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 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 Diagnostics dengue diagnosis DENV NS1 antigen IgM and IgG antibodies ELISA VIDAS<sup>®</sup> |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | performance of vidas sup r 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 |
| topic | dengue diagnosis DENV NS1 antigen IgM and IgG antibodies ELISA VIDAS<sup>®</sup> |
| url | https://www.mdpi.com/2075-4418/13/6/1137 |
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