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
- Author:
Yeong Hoon KIM
1
;
Jihoo LEE
;
Young Eun KIM
;
Chom Kyu CHONG
;
Yanaihara PINCHEMEL
;
Francis REISDÖRFER
;
Joyce Brito COELHO
;
Ronaldo Ferreira DIAS
;
Pan Kee BAE
;
Zuinara Pereira Maia GUSMÃO
;
Hye Jin AHN
;
Ho Woo NAM
Author Information
- Publication Type:Original Article
- Keywords: Zika; flavivirus; diagnostics; RDT; monoclonal antibody; envelope; NS1; cross reaction
- MeSH: Antibodies; Antibodies, Monoclonal; Baculoviridae; Brazil; Cross Reactions; Dengue Virus; Diagnosis; Diagnostic Tests, Routine; Enzyme-Linked Immunosorbent Assay; Flavivirus; Gold Colloid; Hepacivirus; Immunoglobulin G; Immunoglobulin M; Korea; Methods; Neutralization Tests; Point-of-Care Systems; Polymerase Chain Reaction; Reagent Kits, Diagnostic; Sensitivity and Specificity; Sf9 Cells; Yellow Fever; Zika Virus
- From:The Korean Journal of Parasitology 2018;56(1):61-70
- CountryRepublic of Korea
- Language:English
- Abstract: 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.