Technology Bundle ID: TAB-3246

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

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Licensing Contact:
Primary Inventors: 
Elizabeth Hunsperger (CDC)
Co-Inventors: 
Tesfaye Taye (CDC)
Development Stage: 
Pre-clinical (in vivo)
Institute or Center: 
CDC

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.

Applications:
  • 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
  • Advantages:
    • 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

    Patents

    PCT Application PCT/US17/038703
    Filed on 2017-06-22
    US Application 16/310,964
    Filed on 2018-12-18
    US Application 62/353,690
    Filed on 2016-06-23

    Publications

    Hunsperger et al.
    PMID 27225409

    Updated

    Feb 12, 2018

    Data Source: 
    tts