Browse > Article
http://dx.doi.org/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  

Kim, Yeong Hoon (Department of Ophthalmology, College of Medicine, The Catholic University of Korea)
Lee, Jihoo (GenBody Inc.)
Kim, Young-Eun (GenBody Inc.)
Chong, Chom-Kyu (GenBody Inc.)
Pinchemel, Yanaihara (Bahiafarma)
Reisdorfer, Francis (Bahiafarma)
Coelho, Joyce Brito (Bahiafarma)
Dias, Ronaldo Ferreira (Bahiafarma)
Bae, Pan Kee (BioNano Health Guard Research Center)
Gusmao, Zuinara Pereira Maia (Lacen-ba, Laboratorio Central)
Ahn, Hye-Jin (Department of Parasitology, College of Eof Korea)
Nam, Ho-Woo (Department of Parasitology, College of Eof Korea)
Publication Information
Parasites, Hosts and Diseases / v.56, no.1, 2018 , pp. 61-70 More about this Journal
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.
Keywords
Zika; flavivirus; diagnostics; RDT; monoclonal antibody; envelope; NS1; cross reaction;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
연도 인용수 순위
1 To KK, Chan JF, Tsang AK, Cheng VC, Yuen KY. Ebola virus disease: a highly fatal infectious disease reemerging in West Africa. Microbes Infect 2015; 17: 84-97.   DOI
2 Waggoner JJ, Pinsky BA. Zika virus: diagnostics for an emerging pandemic threat. J Clin Microbiol 2016; 54: 860-867.   DOI
3 Lanciotti RS, Kosoy OL, Laven JJ, Velez JO, Lambert AJ, Johnson AJ, Stanfield SM, Duffy MR. Genetic and serologic properties of Zika virus associated with an epidemic, Yap State, Micronesia, 2007. Emerg Infect Dis 2008; 14: 1232-1239.   DOI
4 Faye O, Faye O, Dupressoir A, Weidmann M, Ndiaye M, Alpha Sall A. One-step RT-PCR for detection of Zika virus. J Clin Virol 2008; 43: 96-101.   DOI
5 Balm MN, Lee CK, Lee HK, Chiu L, Koay ES, Tang JW. A diagnostic polymerase chain reaction assay for Zika virus. J Med Virol 2012; 84: 1501-1505.   DOI
6 Faye O, Faye O, Diallo D, Diallo M, Weidmann M, Sall AA. Quantitative real-time PCR detection of Zika virus and evaluation with field-caught mosquitoes. Virol J 2013; 10: 311.   DOI
7 Pyke AT, Daly MT, Cameron JN, Moore PR, Taylor CT, Hewitson GR, Humphreys JL, Gair R. Imported Zika virus infection from the Cook islands into Australia, 2014. PLoS Curr 2014; 6.
8 Goebel S, Snyder B, Sellati T, Saeed M, Ptak R, Murray M, Bostwick R, Rayner J, Koide F, Kalkeri R. A sensitive virus yield assay for evaluation of antivirals against Zika virus. J Virol Methods 2016; 238: 13-20.   DOI
9 Corman VM, Rasche A, Baronti C, Aldabbagh S, Cadar D, Reusken CB, Pas SD, Goorhuis A, Schinkel J, Molenkamp R, Kummerer BM, Bleicker T, Brunink S, Eschbach-Bludau M, Eis-Hubinger AM, Koopmans MP, Schmidt-Chanasit J, Grobusch MP, de Lamballerie X, Drosten C, Drexler JF. Assay optimization for molecular detection of Zika virus. Bull World Health Organ 2016; 94: 880-892.   DOI
10 Gourinat AC, O'Connor O, Calvez E, Goarant C, Dupont-Rouzeyrol M. Detection of Zika virus in urine. Emerg Infect Dis 2015; 21: 84-86.   DOI
11 Musso D, Roche C, Nhan TX, Robin E, Teissier A, Cao-Lormeau VM. Detection of Zika virus in saliva. J Clin Virol 2015; 68: 53-55.   DOI
12 Bingham AM, Cone M, Mock V, Heberlein-Larson L, Stanek D, Blackmore C, Likos A. Comparison of test results for Zika virus RNA in urine, serum, and saliva specimens from persons with travel-associated Zika virus disease - Florida, 2016. MMWR Morb Mortal Wkly Rep 2016; 65: 475-478.   DOI
13 Dick GW. Zika virus. II. Pathogenicity and physical properties. Trans R Soc Trop Med Hyg 1952; 46: 521-534.   DOI
14 Macnamara FN. Zika virus: a report on three cases of human infection during an epidemic of jaundice in Nigeria. Trans R Soc Trop Med Hyg 1954; 48: 139-145.   DOI
15 Marchette NJ, Garcia R, Rudnick A. Isolation of Zika virus from Aedes aegypti mosquitoes in Malaysia. Am J Trop Med Hyg 1969; 18: 411-415.   DOI
16 Lustig Y, Mendelson E, Paran N, Melamed S, Schwartz E. Detection of Zika virus RNA in whole blood of imported Zika virus disease cases up to 2 months after symptom onset, Israel, December 2015 to April 2016. Euro Surveill 2016; 21.
17 Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975; 256: 495-497.   DOI
18 Galfre G, Milstein C. Preparation of monoclonal antibodies: strategies and procedures. Methods Enzymol 1981; 73: 3-46.
19 Friguet B, Chaffotte AF, Djavadi-Ohaniance L, Goldberg ME. Measurements of the true affinity constant in solution of antigen-antibody complexes by enzyme-linked immunosorbent assay. J Immunol Methods 1985; 77: 305-319.   DOI
20 Chong CK, Jeong W, Kim HY, An DJ, Jeoung HY, Ryu JE, Ko AR, Kim YJ, Hong SJ, Yang Z, Nam HW. Development and clinical evaluation of a rapid serodiagnostic test for toxoplasmosis of cats using recombinant SAG1 antigen. Korean J Parasitol 2011; 49: 207-212.   DOI
21 Paz-Bailey G, Rosenberg ES, Doyle K, Munoz-Jordan J, Santiago GA, Klein L, Perez-Padilla J, Medina FA, Waterman SH, Gubern CG, Alvarado LI, Sharp TM. Persistence of Zika virus in dody fluids - preliminary report. N Engl J Med 2017.
22 Triunfol M. A new mosquito-borne threat to pregnant women in Brazil. Lancet Infect Dis 2016; 16: 156-157.   DOI
23 Duffy MR, Chen TH, Hancock WT, Powers AM, Kool JL, Lanciotti RS, Pretrick M, Marfel M, Holzbauer S, Dubray C, Guillaumot L, Griggs A, Bel M, Lambert AJ, Laven J, Kosoy O, Panella A, Biggerstaff BJ, Fischer M, Hayes EB. Zika virus outbreak on Yap Island, Federated States of Micronesia. N Engl J Med 2009; 360: 2536-2543.   DOI
24 Campos GS, Bandeira AC, Sardi SI. Zika virus outbreak, Bahia, Brazil. Emerg Infect Dis 2015; 21: 1885-1886.   DOI
25 Oehler E, Watrin L, Larre P, Leparc-Goffart I, Lastere S, Valour F, Baudouin L, Mallet H, Musso D, Ghawche F. Zika virus infection complicated by Guillain-Barre syndrome--case report, French Polynesia, December 2013. Euro Surveill 2014; 19.
26 Musso D, Gubler DJ. Zika virus. Clin Microbiol Rev 2016; 29: 487-524.   DOI
27 Chan JF, Choi GK, Yip CC, Cheng VC, Yuen KY. Zika fever and congenital Zika syndrome: an unexpected emerging arboviral disease. J Infect 2016; 72: 507-524.   DOI
28 Pessoa R, Patriota JV, Lourdes de Souza Md, Felix AC, Mamede N, Sanabani SS. Investigation into an outbreak of dengue-like illness in Pernambuco, Brazil, revealed a cocirculation of Zika, chikungunya, and Dengue virus type 1. Medicine (Baltimore) 2016; 95: e3201.   DOI
29 Sardi SI, Somasekar S, Naccache SN, Bandeira AC, Tauro LB, Campos GS, Chiu CY. Coinfections of Zika and chikungunya viruses in Bahia, Brazil, identified by metagenomic next-generation sequencing. J Clin Microbiol 2016; 54: 2348-2353.   DOI
30 Musso D, Roche C, Robin E, Nhan T, Teissier A, Cao-Lormeau VM. Potential sexual transmission of Zika virus. Emerg Infect Dis 2015; 21: 359-361.   DOI
31 Chan JF, Lau SK, To KK, Cheng VC, Woo PC, Yuen KY. Middle East respiratory syndrome coronavirus: another zoonotic betacoronavirus causing SARS-like disease. Clin Microbiol Rev 2015; 28: 465-522.   DOI
32 Vorou R. Letter to the editor: diagnostic challenges to be considered regarding Zika virus in the context of the presence of the vector Aedes albopictus in Europe. Euro Surveill 2016; 21: 30161.   DOI
33 Muller DA, Young PR. The flavivirus NS1 protein: molecular and structural biology, immunology, role in pathogenesis and application as a diagnostic biomarker. Antiviral Res 2013; 98: 192-208.   DOI
34 Foy BD, Kobylinski KC, Chilson Foy JL, Blitvich BJ, Travassos da Rosa A, Haddow AD, Lanciotti RS, Tesh RB. Probable non-vector-borne transmission of Zika virus, Colorado, USA. Emerg Infect Dis 2011; 17: 880-882.   DOI
35 Calvet G, Aguiar RS, Melo ASO, Sampaio SA, de Filippis I, Fabri A, Araujo ESM, de Sequeira PC, de Mendonca MCL, de Oliveira L, Tschoeke DA, Schrago CG, Thompson FL, Brasil P, Dos Santos FB, Nogueira RMR, Tanuri A, de Filippis AMB. Detection and sequencing of Zika virus from amniotic fluid of fetuses with microcephaly in Brazil: a case study. Lancet Infect Dis 2016; 16: 653-660.   DOI
36 To KK, Chan JF, Chen H, Li L, Yuen KY. The emergence of influenza A H7N9 in human beings 16 years after influenza A H5N1: a tale of two cities. Lancet Infect Dis 2013; 13: 809-821.   DOI
37 Dejnirattisai W, Supasa P, Wongwiwat W, Rouvinski A, Barba-Spaeth G, Duangchinda T, Sakuntabhai A, Cao-Lormeau VM, Malasit P, Rey FA, Mongkolsapaya J, Screaton GR. Dengue virus sero-cross-reactivity drives antibody-dependent enhancement of infection with Zika virus. Nat Immunol 2016; 17: 1102-1108.   DOI
38 Dai L, Song J, Lu X, Deng YQ, Musyoki AM, Cheng H, Zhang Y, Yuan Y, Song H, Haywood J, Xiao H, Yan J, Shi Y, Qin CF, Qi J, Gao GF. Structures of the Zika virus envelope protein and its complex with a flavivirus broadly protective antibody. Cell Host Microbe 2016; 19: 696-704.   DOI
39 Sirohi D, Chen Z, Sun L, Klose T, Pierson TC, Rossmann MG, Kuhn RJ. The 3.8 The 3.8 A resolution cryo-EM structure of Zika virus. Science 2016; 352: 467-470.   DOI
40 Song H, Qi J, Haywood J, Shi Y, Gao GF. Zika virus NS1 structure reveals diversity of electrostatic surfaces among flaviviruses. Nat Struct Mol Biol 2016; 23: 456-458.   DOI