No abstract

Dengue is a serious tropical disease caused by the mosquito-borne dengue virus (DENV). Performant, rapid, and easy-to-use assays are needed for the accurate diagnosis of acute DENV infection. We evaluated the performance of three prototype assays developed for the VIDAS® automated platform to detect dengue NS1 antigen and anti-dengue IgM and IgG antibodies. Positive and negative agreement with competitor enzyme-linked immunosorbent assays (ELISA) and rapid diagnostic tests (RDT) was evaluated in 91 Lao patients (57 adults, 34 children) with acute DENV infection. The VIDAS® NS1 assay showed the best overall agreement (95.6%) with the competitor NS1 ELISA. Both VIDAS® NS1 and NS1 ELISA assays also demonstrated high sensitivity relative to DENV RNA RT-PCR set as gold standard (85.7% and 83.9%, respectively). In contrast, NS1 RDT was less sensitive relative to DENV RNA RT-PCR (72.7%). The overall agreement of VIDAS® IgM and IgG assays with the competitor assays was moderate (72.5% for IgM ELISA, 76.9% for IgG ELISA, and 68.7% for IgM and IgG RDT). In most analyses, test agreements of the VIDAS® assays were comparable in adults and children. Altogether, the VIDAS® dengue prototypes performed very well and appear to be suitable for routine detection of dengue NS1 antigen and anti-dengue IgM/IgG antibodies.

Dengue is a tropical disease caused by the mosquito-borne dengue virus (DENV) and affecting an estimated 96 million people each year. Performant, rapid and easy-to-use assays are needed for the accurate diagnosis of acute DENV infection. This study evaluated the performance of three prototype assays developed for the VIDAS automated platform to detect dengue NS1 antigen and anti-dengue IgM and IgG antibodies. Positive and negative agreement with competitor enzyme-linked immunosorbent assays (ELISA) and rapid diagnostic tests (RDT) was evaluated in 91 Lao patients (57 adults, 34 children) with acute DENV infection. The VIDAS NS1 assay showed the best overall agreement (95.6%; 95% confidence interval [CI]: 89.1-98.8%) with the competitor NS1 ELISA (Focus Diagnostics). Both assays also demonstrated high sensitivity relative to DENV RNA real time RT-PCR set as gold standard (85.7% [95% CI: 74.3-92.6%] and 83.9% [95% CI: 72.2-91.3%], respectively). Concordance of the VIDAS results was overall higher with the competitor ELISA than with the RDT, suggesting a better performance of VIDAS assays over RDT. The overall agreement of VIDAS IgM and IgG assays with the competitor ELISA (Panbio/Abbott) was moderate (72.5%, 95% CI [62.6-80.6%] for IgM; 76.9%, 95% CI [67.3-84.4%] for IgG), highlighting differences in sensitivity and/or specificity between these assays. In all comparisons, test agreements did not differ significantly between adults and children, indicating comparable performance of the VIDAS assays in both populations. Altogether, the VIDAS dengue prototypes performed very well and appear to be suitable for routine detection of dengue NS1 antigen and anti-dengue IgM/IgG antibodies.

No abstract

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.