Reducing hepatitis C diagnostic disparities with a fully automated deep learning-enabled microfluidic system for HCV antigen detection.

Abstract

Viral hepatitis remains a major global health issue, with chronic hepatitis B (HBV) and hepatitis C (HCV) causing approximately 1 million deaths annually, primarily due to liver cancer and cirrhosis. More than 1.5 million people contract HCV each year, disproportionately affecting vulnerable populations, including American Indians and Alaska Natives (AI/AN). While direct-acting antivirals (DAAs) are highly effective, timely and accurate HCV diagnosis remains a challenge, particularly in resource-limited settings. The current two-step HCV testing process is costly and time-intensive, often leading to patient loss before treatment. Point-of-care (POC) HCV antigen (Ag) testing offers a promising alternative, but no FDA-approved test meets the required sensitivity and specificity. To address this, we developed a fully automated, smartphone-based POC HCV Ag assay using platinum nanoparticles, deep learning image processing, and microfluidics. With an overall accuracy of 94.59%, this cost-effective, portable device has the potential to reduce HCV-related health disparities, particularly among AI/AN populations, improving accessibility and equity in care.