In June 2024, the Food and Drug Administration announced the approval of the first point-of-care hepatitis C RNA test. The test will allow settings operating under a Clinical Laboratory Improvement Amendments (CLIA) Waiver to perform point-of-care hepatitis C RNA testing. A point-of-care hepatitis C RNA test enables a single-visit test-and-treat approach where patients can be tested for hepatitis C, and if positive for hepatitis C RNA, potentially receive treatment during the same visit. 

“A third of people with hepatitis C in the United States don’t even know they have a deadly, yet curable, infection,” said Jonathan Mermin, M.D., M.P.H., director of CDC’s National Center for HIV, Viral Hepatitis, STD and TB Prevention. “This new test provides hope that more people will be cured, but it will only succeed if it is affordable and available.”

For more information on the point-of-care hepatitis C RNA test, visit Cepheid’s Xpert Hepatitis C website and the CDC’s Considerations for the Implementation of Point-of-Care Testing for the Diagnosis of Hepatitis C Virus Infection toolkit.

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