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.