Monoclonal Antibodies for Specific Detection of Dengue Virus Sub-type 4 in Human Serum

Dengue Virus (DENV) non-structural protein 1 (NS1) is secreted in blood during the acute phase of viremic DENV infection. While there are commercially available ELISA assays for DENV NS1 detection, these tests have limited sensitivity (50-70%), do not determine the serotype of the infecting DENV, do not detect all four serotypes equally, or are less sensitive in subsequent DENV infections. There is a critical need for serotype specific diagnostics to inform public health and potentially clinical care interventions. CDC developed three hybridoma cell lines and three DENV-4 serotype-specific monoclonal antibodies (mAbs) for the detection of DENV-4 NS1 in human serum. These mAbs do not cross-react with other dengue virus subtypes (DENV 1, 2, and 3) or other flaviviruses (e.g., West Nile virus or Yellow fever virus) and can be used to develop ELISA and rapid diagnostic tests for dengue detection in resource poor settings. A NS1 DENV serotype specific ELISA would improve disease surveillance by providing early DENV detection and serotype identification, which would improve clinical case management of dengue infections, since early patient diagnosis is critical.

Potential Commercial Applications:		Competitive Advantages:
May be used in several different types of DENV-4 diagnostics: 1) Immunoassay for clinical samples, fixed cell lines, postmortem tissues, and mosquitoes 2) Immunofluorescence assay (IFA) 3) Enzyme linked immunosorbent assay 4) ELISA 5) Microsphere-based assay Government and regional surveillance programs Quality control/quality assurance testing for dengue vaccine candidates		The three mAbs are specific to DENV serotype 4 NS1 and have no cross-reactivity with West Nile virus, Yellow fever virus, or DENV 1, 2, and 3 Early DENV-4 detection and serotype identification is not possible with current diagnostic tests Novel antibodies can be applied to existing kits to increase sensitivity and ease of use Technology may improve DENV-4 detection in resource-limited countries

Related Invention(s):
E-148-2013-0
E-182-2014-0


Inventors:

Elizabeth Hunsperger (CDC)  ➽ more inventions...

Tesfaye Taye (CDC)  ➽ more inventions...


Intellectual Property:
US Pat: - issued -
PCT Application No. PCT/US17/038703 filed on 2017-06-22
US Application No. 16/310,964 filed on 2018-12-18

Publications:
Hunsperger et al. PMID 27225409

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 for Detecting Dengue Virus Sub-type 4 in Human Serum. For collaboration opportunities, please contact CDC TTO at tto@cdc.gov.


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

OTT Reference No: E-057-2016-0
Updated: Feb 12, 2018