Work

Evaluation of ViroTrack Sero Zika IgG/IgM, a New Rapid and Quantitative Zika Serological Diagnostic Assay

Year: 2020

Type: article

Abstract: Background: Dengue virus (DENV) and Zika virus (ZIKV) belong to the flavivirus genus and are antigenically closely related. They also share the same mosquito vector and can cause similar symptoms upon infection. However, DENV and ZIKV infections lead to different clinical sequelae and treatments; therefore, clinicians need rapid and accurate diagnostics capable of distinguishing between the two diseases. Methods: We employed the Immuno-Magnetic Assay technology on a microfluidic cartridge (ViroTrack Sero Zika IgG/IgM) for diagnosis of DENV and ZIKV infection based on aggregation of magnetic nanoparticles. We carried out three serological studies including samples from Dominican Republic, USA, and Nicaragua, aimed at detecting ZIKV-specific IgG and IgM using the ViroTrack Sero Zika IgG/IgM test. Findings: The seroconversion results were comparable with ZIKV IgG and IgM reactivity measured by commercial ZIKV ELISA kit. The sensitivity and specificity for both ZIKV IgG and IgM tested by the ViroTrack Sero Zika IgG/IgM was approximately 98% and 93%, respectively. Interpretation: Serological detection of ZIKV infection by the new ViroTrack Sero Zika IgG/IgM test shows promising performance and limited cross-reactivity with DENV. Funding Statement: This work was financially supported in part by grant AID-OAA-F-16-0089 from USAID to MD and grants from the Ministry of Science and Technology, Taiwan (MOST-106-2622-B-182-002-CC2 &107-2622-B-182-002-CC2) and the Chang Gung Memorial Hospital Research Fund (CMRPD1E0411-3, CMRPD1F0281-2 and CMRPD1H0321-2) to RW. The Nicaraguan studies as well as sample collection and characterization were supported by grants P01 AI106695 and U19 AI118610 to EH and R01 AI099631 to AB from the US National Institutes of Health. This project received support from NIH grant P01. AI106695 to EH and AI107731. Declaration of Interests: The authors have no financial conflicts to declare. Ethics Approval Statement: All patients’ samples were collected from different sources as indicated below and these serum experimentations were under the approval of Research Ethics Board of Chang Gung Memorial Hospital in Taiwan (IRB 201601701B0). The Nicaraguan Pediatric Dengue Cohort Study was approved by the Institutional Review Boards of the University of California, Berkeley, and the Nicaraguan Ministry of Health. Parents or legal guardians of the subjects provided written informed consent, and participants 6 years of age and older provided assent.

Source: Diagnostics

DOI: 10.3390/diagnostics10060372