Grant Number:	7U01CA292771-03 Interpret this number
Primary Investigator:	Mcfall, Sally
Organization:	Northwestern University
Project Title:	Active Hcv Diagnosis to Support Prevention of Hcc in Lmics
Fiscal Year:	2026

Project Summary HCV is a major public health threat, infecting over 58 million people and causing 300,000 deaths from HCV-related cirrhosis or hepatocellular carcinoma (HCC) each year. Sub Saharan Africa has the third highest burden of HCV infection in the world with West African prevalence rates of viremic HCV infection in the general population estimated to be about 7% compared with 1% in the US. In Nigeria, HCV contributes to about a quarter of HCC in Nigeria, one of the country’s leading causes of cancer mortality. Although HCV prevalence is lower in the general U.S. population, infection remains concentrated among underserved populations including people who inject drugs, individuals experiencing homelessness, and incarcerated persons, who face barriers to diagnosis and treatment. Approximately 15-45% of persons infected with HCV will spontaneously clear the virus, therefore positive antibody tests (anti HCV) require confirmation of HCV viremia with laboratory-based molecular HCV testing to identify those who need treatment. This two-step diagnostic pathway creates significant barriers to care, requiring multiple visits, increasing costs, delaying treatment, and resulting in substantial loss to follow-up. These challenges are particularly severe in LMICs where molecular tests are prohibitively expensive and often unavailable because of limited infrastructure and reagent supply. We propose to develop and validate an HCV test for the DASH™ platform for the diagnosis of active HCV at the point of care, by sensitively detecting HCV viral RNA, obviating the requirement for two-step diagnostic pathway. The DASH™HCV test is designed to be easily operated by non-laboratory personnel in decentralized settings that lack laboratory infrastructure. A capillary blood sample is simply collected by fingerstick, added to the test cartridge, and inserted into the DASH™ analyzer. After 15 minutes, an easy-to-read qualitative positive or negative result appears on the unit’s touch screen. Following development, the diagnostic accuracy of DASH™ HCV will be evaluated on both stored plasma and prospectively collected whole blood samples from three clinical validation sites in Nigeria. Validation in Nigeria provides several advantages, including a higher prevalence of active HCV infection, greater viral genetic diversity, and the opportunity to evaluate assay performance more quickly under decentralized, resource-constrained conditions where the clinical benefits of rapid point-of-care molecular testing are greatest. Demonstrating robust performance in these settings will strengthen confidence in the assay's applicability to underserved populations in the United States, including people who inject drugs, individuals experiencing homelessness, incarcerated populations, and rural communities that face similar barriers to laboratory-based testing and linkage to care. This study is expected to lead to the regulatory approval of a small, portable, cheap POC molecular device for the rapid, single step, diagnosis of active HCV that could significantly improve availability and access to HCV testing globally and thus reduce the incidence of HCV- related HCC.




Development of a Rapid Automated Point-of-Care Test for Hepatitis C Viral RNA on the DASH Rapid Polymerase Chain Reaction System.
Authors: Reed J.L. , Butzler M.A. , Hawkins C.A. , Manabe Y.C. , Holden J. , Thomas D.L. , Cox A.L. , McFall S.M. .
Source: The Journal Of Infectious Diseases, 2026-05-15 00:00:00.0; 233(5), p. 823-830.
PMID: 41369203
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