What Hepatitis C Virus (HCV) Diagnostic Tools Are Needed to Advance Diagnosis of Current HCV Infection in Outreach Settings and in a Nonclinical Setting?

Abstract

Given the growing hepatitis C virus (HCV) epidemic in the United States, 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 RNA diagnostic tests have the greatest potential to address this need. Future regulatory approval has been facilitated by a recent change in the US Food and Drug Administration's approach to evaluating point-of-care diagnostic tests that have been developed and validated.