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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

  • Received : 2017.10.16
  • Accepted : 2018.01.20
  • Published : 2018.02.28

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

References

  1. Dick GW. Zika virus. II. Pathogenicity and physical properties. Trans R Soc Trop Med Hyg 1952; 46: 521-534. https://doi.org/10.1016/0035-9203(52)90043-6
  2. 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. https://doi.org/10.1016/0035-9203(54)90006-1
  3. 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. https://doi.org/10.4269/ajtmh.1969.18.411
  4. 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. https://doi.org/10.1056/NEJMoa0805715
  5. Campos GS, Bandeira AC, Sardi SI. Zika virus outbreak, Bahia, Brazil. Emerg Infect Dis 2015; 21: 1885-1886. https://doi.org/10.3201/eid2110.150847
  6. 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.
  7. Triunfol M. A new mosquito-borne threat to pregnant women in Brazil. Lancet Infect Dis 2016; 16: 156-157. https://doi.org/10.1016/S1473-3099(15)00548-4
  8. 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. https://doi.org/10.1016/j.jinf.2016.02.011
  9. 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. https://doi.org/10.1097/MD.0000000000003201
  10. 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. https://doi.org/10.1128/JCM.00877-16
  11. Musso D, Gubler DJ. Zika virus. Clin Microbiol Rev 2016; 29: 487-524. https://doi.org/10.1128/CMR.00072-15
  12. 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. https://doi.org/10.3201/eid2102.141363
  13. 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. https://doi.org/10.3201/eid1705.101939
  14. 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. https://doi.org/10.1016/S1473-3099(16)00095-5
  15. 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. https://doi.org/10.1016/S1473-3099(13)70167-1
  16. 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. https://doi.org/10.1128/CMR.00102-14
  17. 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. https://doi.org/10.1016/j.micinf.2014.11.007
  18. Waggoner JJ, Pinsky BA. Zika virus: diagnostics for an emerging pandemic threat. J Clin Microbiol 2016; 54: 860-867. https://doi.org/10.1128/JCM.00279-16
  19. 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. https://doi.org/10.3201/eid1408.080287
  20. 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. https://doi.org/10.1016/j.jcv.2008.05.005
  21. 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. https://doi.org/10.1002/jmv.23241
  22. 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. https://doi.org/10.1186/1743-422X-10-311
  23. 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.
  24. 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. https://doi.org/10.1016/j.jviromet.2016.09.015
  25. 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. https://doi.org/10.2471/BLT.16.175950
  26. 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. https://doi.org/10.3201/eid2101.140894
  27. 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. https://doi.org/10.1016/j.jcv.2015.04.021
  28. 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. https://doi.org/10.15585/mmwr.mm6518e2
  29. 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.
  30. Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975; 256: 495-497. https://doi.org/10.1038/256495a0
  31. Galfre G, Milstein C. Preparation of monoclonal antibodies: strategies and procedures. Methods Enzymol 1981; 73: 3-46.
  32. 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. https://doi.org/10.1016/0022-1759(85)90044-4
  33. 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. https://doi.org/10.3347/kjp.2011.49.3.207
  34. 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.
  35. 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. https://doi.org/10.2807/1560-7917.ES.2016.21.10.30161
  36. 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. https://doi.org/10.1016/j.antiviral.2013.03.008
  37. 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. https://doi.org/10.1016/j.chom.2016.04.013
  38. 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. https://doi.org/10.1126/science.aaf5316
  39. 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. https://doi.org/10.1038/nsmb.3213
  40. 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. https://doi.org/10.1038/ni.3515

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