Evaluation of VIDAS® diagnostic assay prototypes detecting dengue virus NS1 antigen and anti-dengue virus IgM and IgG antibodies

Abstract

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.

A surface protein−imprinted biosensor based on boronate affinity for the detection of anti−human immunoglobulin G

“…Antibodies are glycoproteins involved in the pathogenesis of autoimmune diseases, which play a critical role in immunopathology [1]. The past years have witnessed the detection of antibodies as an important approach for the diagnosis of several diseases such as HIV [2], dengue [3], Zika virus [4] and autoimmune diseases [5]. Particularly, due to the fast global spread of coronavirus disease (COVID-19) from the end of 2019, assay of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies for evaluating the diagnostic accuracy is especially important for COVID-19 patients [6].…”

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

“…The VIDAS ® DENGUE NS1 Ag (DEAG; 423077), VIDAS ® Anti-DENGUE IgM (DENM; 423078) and VIDAS ® Anti-DENGUE IgG (DENG; 423079) assays (bioMérieux SA, Marcy-l'Étoile, France) are automated qualitative two-step immunoassays developed for VIDAS ® instruments [24]. The VIDAS ® DENGUE NS1 Ag assay detects the dengue NS1 antigen of the four DENV serotypes.…”

“…The VIDAS ® Anti-DENGUE IgM and IgG assays detect IgM and IgG antibodies, respectively, recognising antigens of the four DENV serotypes, owing to the use of a recombinant tetravalent EDIIIT2 protein composed of the antigenic DENV-specific envelope domain III of the four DENV serotypes [24,27]. The three VIDAS ® dengue assays were performed and interpreted according to the instructions for use, as previously described [24]. A test was interpreted as negative when the index value (i) was < 1.0 and positive when i ≥ 1.0.…”

“…Quantitative RT-PCR is often used as gold standard for the detection of acute DENV infection [20,24,31]. To evaluate the sensitivity of the VIDAS ® Dengue NS1 Ag assay, its positive agreement with DENV-specific RT-PCR set as gold standard was evaluated in acute samples and compared to that of the competitor NS1 ELISA (Table 7).…”

“…Combining NS1, IgM and IgG test results is known to improve both sensitivity and specificity of DENV infection diagnosis, especially when patients present at different time points after symptom onset [5,[7][8][9][10]13,14,22,24]. Thus, we evaluated the positive agreement of combined VIDAS ® NS1/IgM and IgM/IgG test results in the total population and at relevant infection stages, i.e., acute stage for NS1/IgM and post-acute stage for IgM/IgG (Table 11).…”