Rapid Point-of-Care Nucleic Acid Test for Hepatitis C using Nanosensors

Project Summary
This project aims to develop a rapid, point-of-care nucleic acid test that genotypes and quantifies viral
load for Hepatitis C infections. By rapidly and affordably providing medical professionals with all the information
they need to make prompt treatment decisions, this nucleic acid test could enable single-visit diagnosis and
treatment initiation. This will help to reduce the number of Hepatitis C patients who go untreated due to a lack of
follow-up after their initial diagnosis. The diagnostic assay is based on nanosensor technology which promises
to electronically detect nucleic acids at the single-molecule level, offering substantial improvements in accuracy,
speed, size, and cost relative to fluorescence-based approaches. The development of this rapid nucleic acid test
will proceed by pursuing two specific aims. Firstly, the diagnostic test will be optimized and validated by detecting
synthetic Hepatitis C spiked into human serum, aiming to achieve an accuracy of 95% over a linear range of
100-107 IU/mL with a limit-of-detection of 10 IU/mL. Secondly, the assay will be performed on clinical blood
samples, demonstrating 99% sensitivity and specificity and >95% concordance with FDA-approved devices. If
successful, this project will establish the feasibility for a rapid point-of-care test for Hepatitis C that, through
improvements in cost, accuracy and speed, could enable a more patient-centric approach to Hepatitis C, offering
diagnosis and treatment in a single medical visit, and reducing the Hepatitis C disease burden worldwide.

Grant Number: 1R43PS005314-01
NIH Institute/Center: ALLCDC
Principal Investigator: Jonathan Alden