title: 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.
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.
authors.affiliation: Department of Biochemistry, College of Natural Sciences, Chungbuk National University, Cheongju, Chungbuk, Republic of Korea.
authors.forename: Jihoo
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Biochemistry, College of Natural Sciences, Chungbuk National University, Cheongju, Chungbuk, Republic of Korea.
authors.forename: Hak-Yong
authors.initials: HY
authors.lastname: Kim
authors.affiliation: GenBody Inc., Biotech Business IC, Dankook University, Cheonan, Chungnam, Republic of Korea. Electronic address: ckchong@genbody.co.kr.
authors.forename: Chom-Kyu
authors.initials: CK
authors.lastname: Chong
authors.affiliation: Department of Infection Biology, Wonkwang University School of Medicine, Iksan, Jeonbuk, Republic of Korea. Electronic address: hosong@wonkwang.ac.kr.
authors.forename: Hyun-Ok
authors.initials: HO
authors.lastname: Song
mesh_terms: D000911:Antibodies, Monoclonal / Q000276:immunology / Q000302:isolation & purification; D000914:Antibodies, Viral / Q000276:immunology / Q000302:isolation & purification; D003715:Dengue / Q000175:diagnosis*; D042241:Early Diagnosis; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D013997:Time Factors; D017361:Viral Nonstructural Proteins / Q000097:blood*
chemical_list: D000911:Antibodies, Monoclonal; D000914:Antibodies, Viral; C100315:NS1 protein, Flavivirus; D017361:Viral Nonstructural Proteins
keywords: Anti-NS1 monoclonal antibody; Dengue virus; NS1 protein; Rapid diagnostic test