What Hepatitis C (HCV) diagnostic tools are needed to advance diagnosis of current HCV infection in outreach settings and in a non-clinical setting?

Abstract

Abstract Given the growing HCV epidemic in the U.S., it is imperative to implement a coordinated, equitable public health approach to HCV testing that will facilitate immediate access to treatment, especially for individuals with limited healthcare access and those who inject drugs. Point-of-care (POC) RNA diagnostic tests have the greatest potential to address this need. Future regulatory approval has been facilitated by a recent change in the FDA’s approach to evaluating POC diagnostic tests that have been developed and validated.