Cepheid Xpert HCV Point of Care Test
On June 27, 2024, the U.S. Food and Drug Administration (FDA) granted marketing authorization to the first point-of-care (POC) fingerstick hepatitis C virus (HCV) RNA test. The availability of a point of care hepatitis C virus RNA test is a significant advancement towards being able to effectively test and treat the estimated 2.4 million (and potentially as many as 4 million) people with hepatitis C in the United States. This new test unlocks the ability to integrate testing and treatment in high-impact settings, which is critical for reaching national hepatitis C elimination goals.
The availability of a point of care hepatitis C virus RNA test, which can provide a qualitative result in in 60 minutes (and as little as 41 minutes), opens the door to a hepatitis C test-and-treat approach. Single encounter testing and treatment has been shown to significantly decrease the time from diagnosis to treatment initiation and the overall number of people initiating treatment for hepatitis C. However, a remaining barrier to single encounter testing and treatment for hepatitis C is the lack of a point of care hepatitis B surface antigen (HBsAg) test to rule out hepatitis B virus coinfection.
Cepheid Xpert® HCV Resources
- Xpert®HCV informational webpage including produce resources, FAQ, and videos
- GeneXpert Xpress System Brochure
- Xpert®HCV Instructions for Use
- Xpert®HCV Quick Reference Guide
- Cepheid Customer Support
- Sample Collection Video
- Xpert®HCV Sample Transfer to Cartridge Video
- Cepheid HCV testing-related YouTube videos
- Positive Controls Manufacture
- Negative Controls Manufacture
- About C360 Data Connectivity
HCV RNA Point of Care Reporting Requirements: New York State Department of Health Electronic Clinical Laboratory Reporting System (ECLRS)
- ECLRS Manual - Hepatitis C Point of Care Testing (PDF)
- Form for requesting access to ECLRS (PDF)
- Checklist for Adding Cepheid Xpert HCV Point of Care Test in New York (PDF)
