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

July 12, 2024 updated by: Cepheid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1012

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Specimens collected from individuals showing signs and symptoms and/or at risk of HCV infection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Capillary whole blood
Capillary whole blood from individuals with signs and symptoms and/or at-risk of HCV infection
Diagnostic test: Xpert HCV
Detection of HCV RNA by Xpert HCV test

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cepheid

Collaborators

Emory University

Investigators

  • Principal Investigator: Jennifer Havens, University of Kentucky College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2024

Primary Completion (Actual)

May 10, 2024

Study Completion (Actual)

June 6, 2024

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 293C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HCV

Clinical Trials on Xpert HCV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe