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; Lee, Jihoo; Kim, Young-Eun; Chong, Chom-Kyu; Pinchemel, Yanaihara; Reisdörfer, Francis; Coelho, Joyce Brito; Dias, Ronaldo Ferreira; Bae, Pan Kee; Gusmão, Zuinara Pereira Maia; Ahn, Hye-Jin; Nam, Ho-Woo

To evaluate the usage of Zika IgG/IgM RDT kit as a reliable diagnostic tool, a comparison test using 30 Zika Mixed Titer Standards showed 100% identical results with the RDT kit against ELISA, PRNT and PCR ( Fig. 5 ; Table 2 ). The diagnostic accuracy of Zika RDT as determined by sensitivity and specificity in a field test was fairly high; with sensitivity and specificity for IgG at 99.0 and 99.3%, respectively, while for IgM it was 96.7 and 98.7%, respectively (Table 3) . Cross reactions with DENV were also determined, in which Zika RDT showed cross-reaction with PVD201 in 16.7% and 5.6% in IgG and IgM, respectively from a total of 18 panels ( Table 4 ). The results showed that all the cross reactions were identified at high titer (> 8.9 s/CO) of DENV antibody posi-tives. Fortunately, no cross-reaction with anti-West Nile virus, anti-yellow fever virus, anti-HCV were observed.