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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06508996

Enrollment

1012

Registered

2024-07-19

Start date

2024-02-06

Completion date

2024-06-06

Last updated

2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV

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.

Interventions

DIAGNOSTIC_TESTXpert HCV

Detection of HCV RNA by Xpert HCV test

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Percent Agreement compared to Patient infected status (PIS)	1 day	Clinical performance comparing Xpert test to PIS (NAAT + Antibody status)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026