Skip to main content
OpenTrials
Completed

NCT Number: NCT02992184

PoC-HCV Genedrive Viral Detection Assay Validation Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

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

-

Treatment and study plan

HCV RNA detection with Genedrive assay

Device

Other names: HCV RNA detection with Point of Care assay

HCV RNA detection with RealTime HCV

Device

Other names: HCV RNA detection with RT-PCR assay

Primary outcomes

  1. Accuracy of HCV RNA detection with PoC assay (Genedrive, Epistem) vs reference standard of commercial real-time polymerase chain reaction (RT-PCR) assay (RealTime HCV, Abbott).

    Time frame: pre-treatment

    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 (with Genedrive channel acceptance set at 2 out of 3).

Secondary outcomes

  1. Diagnostic algorithm optimization

    Time frame: Pre-treatment

    To optimize the diagnostic algorithm (i.e., 1, 2, or 3 out of 3 channels; repeat testing or not) that gives the optimal balance between sensitivity and specificity for detection of HCV RNA.

  2. Factors associated with false-positive of false-negative results

    Time frame: Pre-treatment

    To identify factors associated with false-positive or false-negative results of the PoC assay.

  3. Assess the inter-examiner reproducibility of the PoC assay.

    Time frame: Pre-treatment

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • EPISTEM

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 14, 2016
Registry last updated
Dec 14, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.