title: Enhanced performance of an innovative dengue IgG/IgM rapid diagnostic test using an anti-dengue EDI monoclonal antibody and dengue virus antigen.
abstract: High levels of anti-dengue IgM or IgG can be detected using numerous rapid diagnostic tests (RDTs). However, the sensitivity and specificity of these tests are reduced by changes in envelope glycoprotein antigenicity that inevitably occur in limited expression systems. A novel RDT was designed to enhance diagnostic sensitivity. Dengue viruses cultured in animal cells were used as antigens to retain the native viral coat protein. Monoclonal antibodies (mAbs) were then developed, for the first time, against domain I of envelope glycoprotein (EDI). The anti-dengue EDI mAb was employed as a capturer, and EDII and EDIII, which are mainly involved in the induction of neutralizing antibodies in patients, were fully available to bind to anti-dengue IgM or IgG in patients. A one-way automatic blood separation device prevented reverse migration of plasma and maximize the capture of anti-dengue antibodies at the test lines. A clinical evaluation in the field proved that the novel RDT (sensitivities of 96.5% and 96.7% for anti-dengue IgM and IgG) is more effective in detecting anti-dengue antibodies than two major commercial tests (sensitivities of 54.8% and 82% for SD BIOLINE; 50.4% and 75.3% for PanBio). The innovative format of RDT can be applied to other infectious viral 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: GenBody Inc., Biotech Business IC, Dankook University, Cheonan, Chungnam, Republic of Korea.
authors.forename: Young-Eun
authors.initials: YE
authors.lastname: Kim
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: Hospital Kuala Lumpur, Jalan Pahang, Malaysia.
authors.forename: Mangalam
authors.initials: M
authors.lastname: Sinniah
authors.affiliation: GenBody Inc., Biotech Business IC, Dankook University, Cheonan, Chungnam, Republic of Korea.
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.
authors.forename: Hyun-Ok
authors.initials: HO
authors.lastname: Song
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000276:immunology*; D000914:Antibodies, Viral / Q000276:immunology*; D000956:Antigens, Viral / Q000276:immunology*; D002522:Chlorocebus aethiops; D003429:Cross Reactions / Q000276:immunology; D003715:Dengue / Q000175:diagnosis / Q000276:immunology* / Q000821:virology; D003716:Dengue Virus / Q000276:immunology* / Q000502:physiology; D003955:Diagnostic Tests, Routine / Q000295:instrumentation / Q000379:methods*; D005260:Female; D054884:Host-Pathogen Interactions / Q000276:immunology; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology; D007075:Immunoglobulin M / Q000276:immunology; D008807:Mice, Inbred BALB C; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014709:Vero Cells
chemical_list: D000911:Antibodies, Monoclonal; D000914:Antibodies, Viral; D000956:Antigens, Viral; D007074:Immunoglobulin G; D007075:Immunoglobulin M