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

Cepheid

Status: Completed

Conditions: HCV

Treatments: Diagnostic Test: Xpert HCV

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06508996

293C

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,012 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,012 participants in 1 patient group

Capillary whole blood

Description:

Capillary whole blood from individuals with signs and symptoms and/or at-risk of HCV infection

Treatment:

Diagnostic Test: Xpert HCV