Zika virus infection during pregnancy can cause microcephaly and other severe birth defects. The CDC Zika MAC-ELISA (IgM antibody capture enzyme-linked immunosorbent assay) currently used for diagnosis detects antibodies produced to fight a Zika virus infection. However, reactivity of flavivirus antibodies (from exposure to other mosquito-borne infections such as dengue or West Nile virus) can complicate the interpretation of these results.

CDC and partner researchers have developed six monoclonal antibodies (mAbs) from hybridoma technology with high sensitivity to the Zika virus (ZIKV) pre-membrane/envelope (ENV) protein and limited cross-reactivity to other flaviviruses, notably dengue virus. Multiple methods such as indirect ELISA, bio-layer interferometry (BLI), immunoblotting, immunofluorescence, and plaque reduction neutralization tests (PRNTs) were used to validate the data. Additionally, ZIKV pre-membrane/envelope protein is a candidate biomarker for diagnosis during active infection vs. serological tests (based on identification of IgM and/or IgG) after clearance of infection. The technology can be used for immunoassay development and immunodiagnostic reagents for clinical sample and tissue confirmation of ZIKV. The mAbs also offer improved differentiation between ZIKV and related flaviviruses.