Reducing Hepatitis C diagnostic disparities with a point of care assay for HCV antigen detection

Viral hepatitis continues to be a significant global health issue, with chronic hepatitis B (HBV) and hepatitis C (HCV) responsible for approximately 1 million deaths each year, primarily due to complications such as liver cancer and cirrhosis. Annually, more than 1.5 million individuals contract HCV, with vulnerable populations, including American Indians and Alaska Natives (AI/AN), being disproportionately affected. Although direct-acting antivirals (DAAs) have proven highly effective, the timely and accurate diagnosis of HCV remains a major challenge, particularly in settings with limited resources. The current two-step HCV testing approach is both costly and time-intensive, often resulting in patient loss before appropriate care is administered. Point-of-care (POC) HCV antigen (Ag) testing presents a viable alternative, offering the potential for early detection, even during the acute phase of infection. However, there is currently no FDA-approved POC HCV Ag test that meets the required sensitivity and specificity for detecting low viral loads.