Evaluation of VIDAS® Diagnostic Assay Prototypes Detecting Dengue Virus NS1 Antigen and Anti-Dengue Virus IgM and IgG Antibodies
| Autor: | Ludovic Brossault, Marc Grandadam, Somphavanh Somlor |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Medicine (General) viruses 030106 microbiology 030231 tropical medicine Clinical Biochemistry Dengue virus NS1 Antigen Ns1 antigen NS1 antigen Dengue virus medicine.disease_cause IgM and IgG antibodies Dengue fever 03 medical and health sciences 0302 clinical medicine R5-920 medicine Igg elisa VIDAS® biology DENV business.industry Diagnostic test virus diseases Gold standard (test) biochemical phenomena metabolism and nutrition medicine.disease Virology dengue diagnosis biology.protein ELISA Antibody business human activities |
| Zdroj: | Diagnostics Volume 11 Issue 7 Diagnostics, Vol 11, Iss 1228, p 1228 (2021) |
| ISSN: | 2075-4418 |
| DOI: | 10.3390/diagnostics11071228 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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