More than 2 million adults in the United States are living with hepatitis C virus (HCV) infection, which can lead to severe liver disease and death if untreated. While treatment cures over 95% of cases, nearly one-third of those infected remain undiagnosed. The current two-step diagnostic process—an antibody test followed by a confirmatory nucleic acid test—often misses early infections and leads to incomplete diagnoses. To improve detection and care, the CDC recommends universal screening for adults and pregnant individuals, as well as risk-based testing. Recent advances in diagnostics and the FDA’s reclassification of HCV tests to class II devices have created new opportunities for simpler, faster, and more accessible options, such as point-of-care (POC) RNA and core antigen assays.

This supplement article includes insights from experts convened by the Association of Public Health Laboratories and CDC to explore improvements in hepatitis C diagnostics. Topics include the limitations of the current testing model, the regulatory benefits of down-classification, and the need for CLIA-waived POC tests that support same-day diagnosis and treatment. It also highlights global lessons, sample collection innovations, and strategies for expanding access in outreach and nonclinical settings. Collectively, these insights underscore the need for a coordinated national effort focused on simplified, accurate diagnostics to eliminate hepatitis C in the United States.

Reference: Kamili S, Wester C. Advancing Diagnosis of Current Hepatitis C Virus Infection: A Key to Hepatitis C Elimination in the United States. J Infect Dis. 2024;229(Supplement_3):S313-S315. doi: 10.1093/infdis/jiae127.