Introducing Point-of-Care Testing for Hepatitis C

New York State’s Hepatitis C Dashboard shows that in 2023, 4,783 people were newly diagnosed with HCV in the state, an 8% decrease from 2022. Incidence also decreased, with the rate of new HCV infections dropping from 4.0 to 3.6 per 100,000 population among adult New Yorkers. Despite these gains, progress towards elimination has been stalled by reliance on a multi-step diagnostic algorithm to confirm viremia. In populations with the highest risk of infection – including people who inject drugs – testing and treatment are often inaccessible due to barriers along the care cascade.

On June 27, 2024, the U.S. Food and Drug Administration authorized the first point-of-care (POC) HCV RNA test that can be performed where a person receives care, like an outpatient clinic or mobile unit. The availability of a POC HCV RNA testing, which can provide a qualitative results in 60 minutes, unlocks New York’s ability to integrate a test-and-treat approach where a person can be tested for HCV, and if positive for HCV RNA, be linked to care and potentially receive treatment during the same health care visit. To achieve elimination goals, simplified care that engaged people who inject drugs is essential, and single encounter testing and treatment offers a new tool to significantly expand access, decrease time from diagnosis to treatment and increase the number of New Yorkers who are treated for HCV.

Today’s episode will focus on this new diagnostic tool and its potential impact on HCV elimination across New York. Related Content:

• New York State Department of Health Clinical Guidelines Program, Hepatitis C Virus Screening, Testing, and Diagnosis in Adults (January 2023): https://www.hivguidelines.org/guideline/hcv-testing/?mycollection=hepatitis-care
• New York State Department of Health Hepatitis C Dashboard: https://hcvdashboardny.org/
• New York State Department of Health, Frequently Asked Questions for Hepatitis C Point of Care Diagnostic Testing (June 2025): https://www.health.ny.gov/diseases/communicable/hepatitis/hepatitis_c/providers/docs/poc_faq.pdf
• Erie County Medical Center’s Center for Hepatology Care (La Bodega): https://medicine.buffalo.edu/news_and_events/news/2020/04/martinez-bodega-hepatology-clinic-10699.html
• U.S. Food and Drug Administration News Release, FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test (June 2024): https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-point-care-hepatitis-c-rna-test
• MacIsaac MB, et al. Point-of-care HCV RNA testing improves hepatitis C testing rates and allows rapid treatment initiation among people who inject drugs attending a medically supervised injecting facility. Int J Drug Policy. 2024 March:125:104317. doi:10.1016/j.drugpo.2024.104317.
• Point-of-care HCV RNA testing how to video: https://vimeo.com/1172653335?fl=ip&fe=ec