Rapid Point of Care Diagnostic Tests to Determine Dengue Serostatus

Dengue virus is a leading cause of fever in military deployed to tropical regions. Dengue infections may lead to loss of operational readiness and maybe life threatening and difficult to manage in austere settings. The Department of Defense has a mandate of dengue vaccination for soldiers to be deployed to endemic regions. Current FDA approved dengue vaccine requires pre-vaccination screening of serostatus to determine if it is safe to be vaccinated. A rapid, point of care (POC) diagnostic assay needs to be developed and made available in vaccination clinics as part of large-scale pre-deployment soldier readiness programs. Zymeron develops a POC test that is low-cost, use of a low volume biospecimens such as finger prick blood, and easy-to-use by a healthcare professional without the need of extensive training or laboratory expertise. The POC test will provide immediate digital readout of a soldier’s dengue serostatus, permitting on-the-spot decision about dengue vaccination strategy. The Phase I proposal addresses key technical challenges to develop a highly sensitive and specific dengue serostatus test that differentiates dengue from other flaviviruses. The Phase II project will fully develop the proposed rapid POC test for clinical validation and regulatory submission.