Performance Evaluation of VIDAS Diagnostic Assays Detecting Dengue Virus NS1 Antigen, and Anti-Dengue Virus IgM and IgG Antibodies: a Multicenter, 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(R) 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(R) dengue results were compared to those of competitor enzyme-linked immunosorbent assays (ELISA). The VIDAS(R) dengue assays showed high precision (CV [≤] 10.7%) and limited cross-reactivity ([≤] 15.4%) with other infections. VIDAS(R) 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(R) 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(R) NS1/IgM (96.4% in 0-5 days acute patients) and IgM/IgG (91.9% in post-acute patients) tests. Altogether, the VIDAS(R) 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.