PoC-HCV Genedrive Viral Detection Assay Validation Study

NCT02992184•ANRS, Emerging Infectious Diseases

Summary

The principal objective is to assess the diagnostic accuracy of the PoC assay (Genedrive, Epistem) to detect HCV RNA against the reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott) using stored heparinized plasma from patients with chronic hepatitis C and non-infected controls.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Criteria for case
•Age \> 18 years old.
•Patients with positive HCV RNA.
•Heparinized plasma samples are available before the initiation of antiviral HCV therapy.
•Patients have given a written consent that their blood samples will be further used for research.
•Criteria for control
•Age \> 18 years old.
•Participants were tested negative for anti-HCV antibody
•Heparinized plasma samples are available
•Participants have given a written consent that their blood samples will be further used for research

Exclusion Criteria

•\-

Key Dates

Start Date

September 1, 2016

Primary Completion Date

December 1, 2016

Completion Date

December 1, 2016

Last Updated

December 14, 2016

Enrollment

417

ACTUAL participants

Conditions

Hepatitis C

Interventions

HCV RNA detection with Genedrive assay

DEVICE

HCV RNA detection with RealTime HCV

DEVICE

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

View study

RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PoC-HCV Genedrive Viral Detection Assay Validation Study

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Persuasive Health Communication Intervention for HIV/HCV

The National Australian HCV Point-of-Care Testing Program

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures