Xpert Hepatitis-C Virus (HCV) Test on the GeneXpert Xpress System

Clinical Evaluation of the Xpert® HCV Test on the GeneXpert® Xpress System

A multi-site prospective, all comers study that was conducted at geographically diverse locations in the United States.

Whole blood specimens were collected from consented individuals with signs and symptoms and/or individuals at-risk of HCV infection, irrespective of HCV antibody status at a single timepoint.

Inclusion Criteria:

• Participant was ≥18 years old
• Participant was not on treatment at time of enrollment based on review of medical records or self-reported
• Participant had signs and symptoms and/or is considered at-risk of HCV infection

Exclusion Criteria:

• Clinician assessed that the participant was not suitable for inclusion