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

Cepheid1,012 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,012

Conditions

HCV

Interventions

Xpert HCVDIAGNOSTIC_TEST

Detection of HCV RNA by Xpert HCV test

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Percent Agreement compared to Patient infected status (PIS)

Clinical performance comparing Xpert test to PIS (NAAT + Antibody status)

Time frame: 1 day

Data from ClinicalTrials.gov

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