SEVIDENT, INC. — Department of Health and Human Services SBIR Phase I: NIAID

Description

DESCRIPTION provided by applicant Dengue virus DENV is a major public health problem of growing global importance with billion people at risk of infection million cases reported annually and associated costs of $ billion per year in the Western Hemisphere DENV is a mosquito borne virus and the causative agent of dengue fever dengue hemorrhagic fever and dengue shock syndrome and is often misdiagnosed due to the non specific clinical manifestations of this febrile illness With more than million Americans traveling to endemic areas dengue infections are now more common in travelers returning to the U S than malaria There is an urgent need for rapid sensitive and specific point of care compatible DENV diagnostic tools for improved patient care and public health surveillance In this application we will explore the discovery that a novel capture technology CAP TECH designed for the specific capture of DENV ViCAP DENV constructed on point of care compatible solid phase paramagnetic microparticles and their use in a fluorescent immunoassay FIA enabled the rapid detection of DENV in minutes Further in a comparative study the sensitivity of fluorescent signal observed by the ViCAP DENV FIA prototype was comparable to the signal observed by qRT PCR but in a fraction of the time and cost Our overriding hypothesis is that the use of a diagnostic tool such as ViCAP DENV FIA will enable the rapid and sensitive detection of Dengue virus in blood samples the eventual use of which could improve patient outcomes Further optimization of ViCAP DENV and the FIA Aim and an initial clinical evaluation of ViCAP DENV FIA performance in a side by side comparison study against FDA approved DENV test methods using de identified serum samples collected by the Sustainable Sciences Institute and the Nicaraguan Ministry of Health Aim will provide the foundational work for future product development and field testing evaluations in Phase II The success of this application will provide a novel and cost effective point of care compatible test design for the rapid diagnosis of viral infection from samples within minutes PUBLIC HEALTH RELEVANCE In this application we will explore the discovery that a novel capture technology CAP TECH designed for the specific capture of Dengue Virus DENV signatures constructed on point of care compatible paramagnetic microparticles and their use in a fluorescent immunoassay enabled the rapid detection of DENV in minutes the results of which were comparable to qRT PCR The success of this application will provide a novel and cost effective point of care compatible test design for the rapid diagnosis of viral infection fro samples within minutes