TY - JOUR
T1 - Performance of VIDAS® Diagnostic Tests for the Automated Detection of Dengue Virus NS1 Antigen and of Anti-Dengue Virus IgM and IgG Antibodies
T2 - A Multicentre, International Study
AU - Versiani, Alice F.
AU - Kaboré, Antoinette
AU - Brossault, Ludovic
AU - Dromenq, Loïc
AU - dos Santos, Thayza M.I.L.
AU - Milhim, Bruno H.G.A.
AU - Estofolete, Cássia F.
AU - Cissé, Assana
AU - Sorgho, Pegdwendé Abel
AU - Senot, Florence
AU - Tessonneau, Marie
AU - Diagbouga, Serge
AU - Nogueira, Mauricio L.
N1 - Funding Information:
L.B., L.D., F.S. and M.T. are employees of bioMérieux. M.L.N. and S.D. received compensation fees from bioMérieux for this study, in the framework of the agreement signed with their employer entity. This study was funded by bioMérieux. The funder was involved in the design and execution of the study, in the data interpretation, and in the writing of the manuscript.
Funding Information:
The authors are grateful to Agnès Foussadier (bioMérieux) for her scientific contribution, Françoise Gay-Andrieu (bioMérieux) for her medical advisory support, Nadège Goutagny (bioMérieux) for discussions on the manuscript, Nafissatou Ilboudo, Fatoumata Maïga, Zoumana Bado, Adéline Sandwidi, Félix Lompo and Yacouba Barro (IRSS) for their contribution in patient enrolment and baseline data collection, and to Jacques simpore (CERBA), Théophane Yonli (CERBA), and Arthur Djibougou (IRSS/Centre MURAZ) for their assistance in conducting the clinical trial. A.F.V. was a postdoctoral fellow of the São Paulo Research Foundation (FAPESP #2018/17647-0) during the time of this research. The authors thank Anne Rascle of AR Medical Writing (Regensburg, Germany) for providing medical writing support, which was funded by bioMérieux (Marcy L’Etoile, France), in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ; accessed on 11 February 2022).
Publisher Copyright:
© 2023 by the authors.
PY - 2023/3
Y1 - 2023/3
N2 - 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.
AB - 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.
KW - dengue diagnosis
KW - DENV
KW - ELISA
KW - IgM and IgG antibodies
KW - NS1 antigen
KW - VIDAS
UR - http://www.scopus.com/inward/record.url?scp=85151653174&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85151653174&partnerID=8YFLogxK
U2 - 10.3390/diagnostics13061137
DO - 10.3390/diagnostics13061137
M3 - Article
AN - SCOPUS:85151653174
SN - 2075-4418
VL - 13
JO - Diagnostics
JF - Diagnostics
IS - 6
M1 - 1137
ER -