STTR Phase I: A system for collection, transportation and accurate analysis of RNA virus specimens

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to support a testing device for collection, transportation and diagnosis of certain viral infections, such as hepatitis C virus (HCV), human immunodeficiency virus (HIV) and measles. Recent viral outbreaks of measles, Ebola, Zika, SARS-CoV, and the COVID-19 pandemic have illustrated the need for fast and accurate diagnosis to contain the outbreak, as well as for decentralized testing during periods of quarantine or general global epidemiological surveillance. The technology will enable at-home or remote location specimen collection without the need for traditional, costly, draw stations and overnight cold-pack shipments. The initial target is hepatitis C virus (HCV) infections. The United States Centers for Disease Control and Prevention (CDC) recommend that adults should be screened for HCV infection at least once in their lifetimes, and women should be screened during each pregnancy. This Small Business Technology Transfer (STTR) Phase I project will focus on solving the inherent instability of RNA viruses. RNA viruses, in liquid blood and especially dry, degrade rapidly. It is why SARS-COV-2 is primarily a contact/aerosol transmission and not a problem with packages. RNA samples have a high sensitivity to ribonucleases (enzymes that catalyze the degradation of RNA) and degrade in a short period of time when dried. Thiis project will create a special protective environment so that when the specimen dries it does not degrade; it will consist of a device that retains a fixed and known amount of specimen, desiccant for drying, and modified atmospheric packaging (MAP) preventing specimen degradation at ambient temperature for up to 14 days. The MAP prevents gas exchange during transit, enabling collection and transport in any weather conditions including cold, heat, and high humidity. Upon arrival at the laboratory, an extraction process will recover the RNA virus for testing via RT-qPCR. This project will evaluate the impact of drying time, inhibition of ribonucleases, gas content within the MAP, transport media, extraction buffer, and RT-qPCR techniques to stabilize and quantify HCV. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.