A modular platform for infectious disease surveillance at point-of-need.

ABSTRACT We propose to develop a point-of-need system for differential molecular identification of filoviruses from syndromically similar infections. Our goal is to enable rapid, sensitive, and specific identification of quarantinable infections to reduce nosocomial risk and improve outbreak response. The platform will simultaneously test 12 genomic markers at the genus and strain level using a modular microfluidic design that allows for rapid panel update and expansion. In Phase I we will develop an assay for pan-filovirus (pFi), followed by expansion of the panel and system integration in Phase II. The expanded panel will add pan-flavivirus (pFa) and pan-Plasmodium (pPa) detection as well as strain-specific targets for Ebola, Marburg, Dengue, Yellow Fever, and Malaria. Strain specific tests will enable better patient triage/treatment during an outbreak and improve disease surveillance in non-outbreak settings. The panel will require a 50 μL sample of whole blood and will achieve highly specific detection in andlt; 30 minutes. To achieve this goal, we will combine Redbud Labs’ expertise in microfluidics and systems with the diagnostic development expertise of the Diagnostics Program at PATH (Seattle, WA), and the VHF testing/processing capabilities of the Connor Lab at Boston University (part of the BSL-4 facilities at NEIDL).NARRATIVE In this Fast Track, the project team proposes to develop a system that may be used as a research use only (RUO) device to improve the surveillance of infectious diseases and to support the rapid development of point-of-need molecular diagnostic assay components, such as new primer sets for isothermal amplification. The system design will be modular to support accelerated infectious disease panel development beyond the scope of this project.