Development of a Rapid Diagnostic Test Kit to Detect IgG/IgM Antibody against Zika Virus Using Monoclonal Antibodies to the Envelope and Non-structural Protein 1 of the Virus

The Korean Journal of Parasitology

Young-Eun Kim^2¹  Chom-Kyu Chong^2²  Yeong Hoon Kim^1³  Francis Reisdörfer^3⁴  Jihoo Lee^2⁵  Yanaihara Pinchemel^3⁶ 

[1] Bahiafarma, Simoes Filho, Bahia, Brazil^3;BioNano Health Guard Research Center, Daejeon 34141, Korea^4;Department of Ophthalmology, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea^1;Department of Parasitology, College of Medicine, Catholic University of Korea, Seoul 06591, Korea^6;GenBody Inc., Cheonan 31116, Korea^2;Lacen-ba, Laboratorio Central, Bahia, Brazil^5

关键词: Zika;    flavivirus;    diagnostics;    RDT;    monoclonal antibody;    envelope;    NS1;    cross reaction;   

DOI  :  10.3347/kjp.2018.56.1.61

学科分类：生物科学（综合）

来源: The Korean Society for Parasitology

【 摘 要 】

We developed a Rapid Diagnostic Test (RDT) kit for detecting IgG/IgM antibodies against Zika virus (ZIKV) using monoclonal antibodies to the envelope (E) and non-structural protein 1 (NS1) of ZIKV. These proteins were produced using baculovirus expression vector with Sf9 cells. Monoclonal antibodies J2G7 to NS1 and J5E1 to E protein were selected and conjugated with colloidal gold to produce the Zika IgG/IgM RDT kit (Zika RDT). Comparisons with ELISA, plaque reduction neutralization test (PRNT), and PCR were done to investigate the analytical sensitivity of Zika RDT, which resulted in 100% identical results. Sensitivity and specificity of Zika RDT in a field test was determined using positive and negative samples from Brazil and Korea. The diagnostic accuracy of Zika RDT was fairly high; sensitivity and specificity for IgG was 99.0 and 99.3%, respectively, while for IgM it was 96.7 and 98.7%, respectively. Cross reaction with dengue virus was evaluated using anti-Dengue Mixed Titer Performance Panel (PVD201), in which the Zika RDT showed cross-reactions with DENV in 16.7% and 5.6% in IgG and IgM, respectively. Cross reactions were not observed with West Nile, yellow fever, and hepatitis C virus infected sera. Zika RDT kit is very simple to use, rapid to assay, and very sensitive, and highly specific. Therefore, it would serve as a choice of method for point-of-care diagnosis and large scale surveys of ZIKV infection under clinical or field conditions worldwide in endemic areas.

【 授权许可】

Free