Korean J Parasitol.  2018 Feb;56(1):61-70. 10.3347/kjp.2018.56.1.61.

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

Affiliations
  • 1Department of Ophthalmology, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.
  • 2GenBody Inc., Cheonan 31116, Korea.
  • 3Bahiafarma, Simoes Filho, Bahia, Brazil.
  • 4BioNano Health Guard Research Center, Daejeon 34141, Korea.
  • 5Lacen-ba, Laboratorio Central, Bahia, Brazil.
  • 6Department of Parasitology, College of Medicine, Catholic University of Korea, Seoul 06591, Korea. howoo@catholic.ac.kr

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.

Keyword

Zika; flavivirus; diagnostics; RDT; monoclonal antibody; envelope; NS1; cross reaction

MeSH Terms

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*
Antibodies
Antibodies, Monoclonal
Gold Colloid
Immunoglobulin G
Immunoglobulin M
Reagent Kits, Diagnostic
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