FAST-DENV™: A Point-of-Care Dengue Serodiagnostic

Dengue virus (DENV) is the most prevalent mosquito-borne viral pathogen in the world with nearly 400 million infections occurring annually. The infection risk for deployed troops has increased with the global incidence of dengue, leading to a loss in mission capabilities as soldiers are hospitalized, treated, and evacuated. DengVaxia, a recombinant live-attenuated tetravalent vaccine, is licensed and available in 20 countries. However, Phase 3 clinical trials indicated an increased risk of dengue complications if the vaccine was administered to those that had no prior dengue infection. Current methods to determine serostatus include the plaque reduction neutralization test or ELISA, though these tests are currently not available at the point-of-care, require skilled personnel, cold-chain transport, and are not suitable for large-scale vaccination programs. Thus, there is a critical need for a sensitive, high throughput technology to rapidly determine DENV serostatus and inform vaccination strategies. Luna Innovations is therefore developing the FAST-DENV technology, featuring automated microfluidic point-of-care IgM, IgG, and IgG avidity ELISAs. During Phase I, ELISAs were developed and demonstrated to enable rapid (≤15 minutes) and high accuracy detection of dengue viral antibodies from clinical specimens with a sample requirement of ≤1 µL plasma/ELISA for use with finger-prick sample volumes.