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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: 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.

SUBMITTER: Versiani AF

PROVIDER: S-EPMC10047366 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Performance of VIDAS<sup>®</sup> Diagnostic Tests for the Automated Detection of Dengue Virus NS1 Antigen and of Anti-Dengue Virus IgM and IgG Antibodies: A Multicentre, International Study.

Versiani Alice F AF Kaboré Antoinette A Brossault Ludovic L Dromenq Loïc L Dos Santos Thayza M I L TMIL Milhim Bruno H G A BHGA Estofolete Cássia F CF Cissé Assana A Sorgho Pegdwendé Abel PA Senot Florence F Tessonneau Marie M Diagbouga Serge S Nogueira Mauricio L ML

Diagnostics (Basel, Switzerland) 20230316 6

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<sup>®</sup> 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. V ...[more]

PMID: 36980445

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Project description:IntroductionRapid diagnostic tests (RDTs) were evaluated, in this paper, for their utility as a reliable test, using resource-constrained studies. In most studies, NS1 antigen and immunoglobulin M (IgM)-based immunochromatographic tests (ICTs) were considered for acute phase detection. We aimed to evaluate the diagnostic accuracy of NS1, IgM, and NS1/IgM-based ICTs to detect acute dengue virus (DENV) infection in dengue-endemic regions.MethodsStudies were electronically identified using the following databases: MEDLINE, Embase, Cochrane Library, Web of Science, and CINAHL Plus. Keywords including dengue, rapid diagnostic test, immunochromatography, sensitivity, specificity, and diagnosis were applied across databases. In total, 15 studies were included. Quality assessment of the included studies was performed using the QUADAS-2 tool. All statistical analyses were conducted using RevMan, MedCalc, and SPSS software.ResultsThe studies revealed a total of 4135 individuals, originating largely from the Americas and Asia. The prevalence of DENV cases was 53.8%. Pooled sensitivities vs. specificities for NS1 (only), IgM (only) and combined NS1/IgM were 70.97% vs. 94.73%, 40.32% vs. 93.01%, and 78.62% vs. 88.47%, respectively. Diagnostic odds ratio (DOR) of DENV for NS1 ICTs was 43.95 (95% CI: 36.61-52.78), for IgM only ICTs was 8.99 (95% CI: 7.25-11.16), and for NS1/IgM ICTs was 28.22 (95% CI: 24.18-32.95). ELISA ICTs yielded a DOR of 21.36, 95% CI: 17.08-26.741. RT-PCR had a DOR of 40.43, 95% CI: 23.3-71.2. Heterogeneity tests for subgroup analysis by ICT manufacturers for NS1 ICTs revealed an χ2 finding of 158.818 (df = 8), p < 0.001, whereas for IgM ICTs, the χ2 finding was 21.698 (df = 5), p < 0.001.ConclusionNS1-based ICTs had the highest diagnostic accuracy in acute phases of DENV infection. Certain factors influenced the pooled sensitivity, including ICT manufacturers, nature of the infection, reference method (RT-PCR), and serotypes. Prospective studies may examine the best strategy for incorporating ICTs for dengue diagnosis.

Project description:Dengue is an acute febrile illness caused by positive-sense single-stranded RNA virus, belonging to the family Flaviviridae and genus Flavivirus. Transmission of virus among the individuals occurred by blood-feeding Aedes mosquitoes. This virus has four serotypes differentiated on the basis of antibody neutralization assay. At present, there is no particular treatment or vaccine candidate available for dengue infection. Approximately 3.9 billion human populations are at risk of dengue virus (DENV) infection. Thus, precise diagnosis of dengue at the early stage is very essential for disease control and effective therapy in order to treat or prevent severe complications. Indeed, the accurate diagnosis of DENV remains a problem because of low detection accuracy along with high testing price. Sensitivity and specificity of available kits vary from test to test, and cross-reactivity with other Flavivirus is a challenging issue for diagnosis. In this study, linear epitopes of envelope (E) and NS1 proteins were identified to diagnose the DENV. Whole protein sequences of E and NS1 of DENV were obtained from UniProtKB database. On the basis of algorithm prediction from DNASTAR, BCEPRED, and IEDB data resources, twelve peptides of E (EP1 to EP12) and eight peptides of NS1 (NS1-1 to NS1-8) were selected, which were common in all serotypes. Sequence homologies of peptides with other Flavivirus were checked by Multiple Sequence Alignment Tool ClustalX2. Peptide sequences were synthesized chemically by solid-phase peptide synthesis technique. Dengue-specific IgM and IgG (secondary response) antibodies in the patient's antisera were tested with the peptides using ELISA protocol. Peptides EP1, EP2, EP4, EP7, EP10, and EP12 of E protein and NS1-1, NS1-3, NS1-4, NS1-7, and NS1-8 of NS1 protein were considered the best immunoreactive peptides with the sensitivity (73.33-96.66%) and specificity (82.14-100%). Such peptides together can be used to construct the multiple antigen peptides (MAP) or multiplexed microbeads for designing a precise, cost-effective, and easy-to-make peptide-based immunodiagnostic kit for DENV detection.

Project description:BackgroundDengue diagnosis is complex and until recently only specialized laboratories were able to definitively confirm dengue infection. Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combined dengue rapid test for the detection of NS1 and IgM/IgG antibodies. The evaluation was made prospectively in the field conditions and included the study of the impact of its use as a point-of-care test for case management as well as retrospectively against a panel of well-characterized samples in a reference laboratory.Methodology/principal findingsDuring the prospective study, 157 patients hospitalized for a suspicion of dengue were enrolled. In the hospital laboratories, the overall sensitivity, specificity, PPV and NPV of the NS1/IgM/IgG combination tests were 85.7%, 83.9%, 95.6% and 59.1% respectively, whereas they were 94,4%, 90.0%, 97.5% and 77.1% respectively in the national reference laboratory at Institut Pasteur in Cambodia. These results demonstrate that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. The analysis of the medical records indicates that the physicians did not take into consideration the results obtained with the rapid test including for care management and use of antibiotic therapy.ConclusionsIn the context of our prospective field study, we demonstrated that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case but a negative result doesn't rule out a dengue infection. Nevertheless, Cambodian pediatricians in their daily practice relied on their clinical diagnosis and thus the false negative results obtained did not directly impact on the clinical management.

Dataset Information

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.

Publications

Performance of VIDAS<sup>®</sup> Diagnostic Tests for the Automated Detection of Dengue Virus NS1 Antigen and of Anti-Dengue Virus IgM and IgG Antibodies: A Multicentre, International Study.

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Dataset Information

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.

Publications

Performance of VIDAS<sup>®</sup> Diagnostic Tests for the Automated Detection of Dengue Virus NS1 Antigen and of Anti-Dengue Virus IgM and IgG Antibodies: A Multicentre, International Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

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.