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.
Highlights
Accepted: 5 July 2021Dengue is a mosquito-borne viral disease caused by infection with any of four dengue virus (DENV) serotypes (DENV-1 to DENV-4) [1]
Out of 250 plasma samples of patients with suspected DENV infection, 91 samples of acute DENV infection (RT-PCR-positive and/or non-structural protein 1 (NS1) FOCUS-positive) were tested with all three VIDAS® Dengue prototype assays and all three competitor enzyme-linked immunosorbent assays (ELISA) assays for dengue NS1 antigen, anti-DENV IgM, and anti-DENV immunoglobulin G (IgG) antibodies
These results are in line with reports from the literature demonstrating a good concordance between DENV NS1 antigen and reverse-transcription PCR (RT-PCR) assays in acute DENV infection, as well as a better concordance of ELISA-based than of rapid diagnostic tests (RDT)-based results to RT-PCR [21]
Summary
Dengue is a mosquito-borne viral disease caused by infection with any of four dengue virus (DENV) serotypes (DENV-1 to DENV-4) [1]. Following an early febrile phase that lasts for 2 to 7 days, patients enter a critical phase during which their condition either improves or worsens, and may evolve into life-threatening severe dengue with a potentially fatal outcome [1,3]. DENV serotype and secondary infection are among the factors associated with disease severity [1]. If the patient survives the first 24–48-h critical phase, the final recovery phase will take its course over the following 48–72 h [1,3]. The first licensed dengue vaccine is restricted to people aged 9–45 years and is only recommended for those with evidence of a past dengue infection [5]
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