CClinicalTrials.gg
CompletedNCT06508996Updated Jul 19, 2024

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

An observational study in HCV, sponsored by Cepheid. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by Cepheid · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,012
Ages
18 Years and older
Sex
All
01

Study summary

A multi-site prospective, all comers study that was conducted at geographically diverse locations in the United States.

Read the 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.

02

Conditions studied

  • HCV
03

In context

Lead sponsor

Cepheid is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • Clinician assessed that the participant was not suitable for inclusion
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,012 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Capillary whole blood

    Capillary whole blood from individuals with signs and symptoms and/or at-risk of HCV infection

    Diagnostic Test: Xpert HCV

Interventions

  • Diagnostic testXpert HCV

    Detection of HCV RNA by Xpert HCV test

06

What researchers measure

Primary outcomes

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

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

    Time frame: 1 day

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Study locations

1 site
  • University of Kentucky
    Lexington, Kentucky 40508, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06508996
Lead sponsor
Cepheid
Collaborators
Emory University
Responsible party
Sponsor
First posted
Jul 19, 2024
Start date
Feb 6, 2024
Primary completion
May 10, 2024
Completion
Jun 6, 2024
Last update
Jul 19, 2024

Study contacts

Jennifer Havens
principal investigator · University of Kentucky College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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