Xpert Hepatitis-C Virus (HCV) Test on the GeneXpert Xpress System
Completed
- Conditions
- HCV
- Interventions
- Diagnostic Test: Xpert HCV
- Registration Number
- NCT06508996
- Lead Sponsor
- Cepheid
- Brief Summary
A multi-site prospective, all comers study that was conducted at geographically diverse locations in the United States.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1012
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Capillary whole blood Xpert HCV Capillary whole blood from individuals with signs and symptoms and/or at-risk of HCV infection
- Primary Outcome Measures
Name Time Method Percent Agreement compared to Patient infected status (PIS) 1 day Clinical performance comparing Xpert test to PIS (NAAT + Antibody status)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Kentucky
🇺🇸Lexington, Kentucky, United States