Clinical Performance Evaluation of DxN HCV Assay

ClinicalTrials.gov ID: NCT03125408

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Official title

Clinical Utility of the DxN HCV Assay as an Aid in the Management of HCV-Infected Individuals Undergoing Antiviral Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in the management of of HCV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HCV Assay for plasma samples in the intended use population.

Study identification

NCT ID: NCT03125408
Recruitment status: Terminated
Study type: Observational
Phase: Not listed
Lead sponsor: Beckman Coulter, Inc.; Industry
Enrollment: 210 participants

Conditions and interventions

Conditions

Hepatitis C

Interventions

HCV Assay Diagnostic Test

Diagnostic Test

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 2, 2012 (Type not available)
Primary completion: Aug 30, 2017 (Actual)
Completion: Aug 30, 2017 (Actual)
Last update posted: Jul 12, 2018

2012 – 2017

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
SC Liver Research Consortium	Duluth	Georgia	30096	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03125408, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 12, 2018 · Synced Nov 15, 2026