Development and Commercialization of Analyte Specific Reagents (ASRs) for the Diagnosis of Selected Arthropod-Borne Viruses on FDA-Cleared Real-time P

During Phase I, probes and primers were designed and tested for six arbovirus diseases: Dengue Fever, Rift Valley Fever, Chikungunya, Crimean-Congo Hemorrhagic Fever, Sand Fly Fever, and Tick-Borne Encephalitis. Positive and negative controls were designed, produced, and tested as well. Phase II will extend the work, establishing limits of detection, linearity, sensitivity, and specificity for the assays. Further testing will include clinical samples from infected personnel and comparison to "gold standards". At least three lots of the successful assays will be manufactured under cGMP guidelines according to the FDA, and provided to the military for testing as Analyte Specific Reagents (ASRs). Feedback from military medical personnel will be used to format assays which can be used in existing JBAIDS qPCR instruments.