Monoclonal Antibodies that Bind Zika Virus Envelope Protein for Zika Diagnostics and Research

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.

Potential Commercial Applications:		Competitive Advantages:
Engineering of mAbs for commercial diagnostic applications Clinical diagnostic assay to detect active Zika virus infection Multiple platforms such as immunoassay, lateral flow diagnostics, and nanotechnology device capable of interfacing with smartphone/digital technology ENV protein target is a valid target for diagnostic development with the understanding that a sufficient viral load needs to be present These mAbs may serve in a competition serological assay for dengue (or other closely related flaviviruses) where clinical IgG/IgM that do not compete with these ZIKV-specific mAbs for r-Env or VLP, can exclude a previous ZIKV infection Immunodiagnostic reagents for confirmation of Zika virus in clinical samples (e.g., serum, saliva and/or urine) or tissue Differentiation between Zika and related flaviviruses such as dengue, yellow fever or West Nile viruses Can be useful in more generalized diagnostic assay development to detect all flaviviruses Research tool, monitoring and public health surveillance Antiviral efficacy testing in animal models		May be used for diagnosis during active Zika virus infection vs. serological tests (based on identification of IgM and/or IgG) after clearance of infection Offers higher sensitivity than many commercial and academic mAbs available to detect ZIKV Limited cross-reactivity with other flaviviruses High affinity mAbs (bind more quickly to the antigen and with a stronger bond)

Related Invention(s):
E-341-2013-0
E-341-2013-1
E-286-2016-0
E-081-2017-0
E-107-2016-1


Inventors:

Jason Goldstein (CDC)  ➽ more inventions...

Dennis Bagarozzi (CDC)  ➽ more inventions...

Madhavan Nallani


Intellectual Property:
US Application No. 62/622,521
Research Tool - Patent protection is not being pursued for this technology.

Collaboration Opportunity:
The CDC Technology Transfer Office (TTO) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize: Monoclonal Antibodies that Bind Zika Virus Envelope Protein for Zika Diagnostics and Research. For collaboration opportunities, please contact CDC TTO at tto@cdc.gov or 1-404-639-1330.


Licensing Contact:
Jeremiah Mitzelfelt,
Email: jeremiah.mitzelfelt@nih.gov
Phone: 301-443-8518

OTT Reference No: E-030-2017-0
Updated: Feb 9, 2021