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

Abstract

AbstractDengue 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 anti-bodies. 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, 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.