Development and clinical evaluation of a highly accurate dengue NS1 rapid test: from the preparation of a soluble NS1 antigen to the construction of an RDT.
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| Abstract |
Early diagnosis of dengue virus (DENV) is important. There are numerous products on the market claiming to detect DENV NS1, but these are not always reliable. In this study, a highly sensitive and accurate rapid diagnostic test (RDT) was developed using anti-dengue NS1 monoclonal antibodies. A recombinant NS1 protein was produced with high antigenicity and purity. Monoclonal antibodies were raised against this purified NS1 antigen. The RDT was constructed using a capturing (4A6A10, Kd=7.512±0.419×10(-9)) and a conjugating antibody (3E12E6, Kd=7.032±0.322×10(-9)). The diagnostic performance was evaluated with NS1-positive clinical samples collected from various dengue endemic countries and compared to SD BioLine Dengue NS1 Ag kit. The constructed RDT exhibited higher sensitivity (92.9%) with more obvious diagnostic performance than the commercial kit (83.3%). The specificity of constructed RDT was 100%. The constructed RDT could offer a reliable point-of-care testing tool for the early detection of dengue infections in remote areas and contribute to the control of dengue-related diseases.
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| Authors | Jihoo Lee, Hak-Yong Kim, Chom-Kyu Chong, Hyun-Ok Song |
| Journal | Diagnostic microbiology and infectious disease (Diagn Microbiol Infect Dis) Vol. 82 Issue 2 Pg. 128-34 (Jun 2015) ISSN: 1879-0070 [Electronic] United States |
| PMID | 25824725 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't) |
| Copyright | Copyright © 2015 Elsevier Inc. All rights reserved. |
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