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OpenTrials
Completed

NCT Number: NCT06508996

Xpert Hepatitis-C Virus (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.

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Key information

Conditions

HCV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky

Lexington, Kentucky, 40508, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xpert HCV

Diagnostic Test

Detection of HCV RNA by Xpert HCV test

Primary outcomes

  1. Percent Agreement compared to Patient infected status (PIS)

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Cepheid

Industry

Collaborators

  • Emory University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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