PoC-HCV Genedrive Viral Detection Assay Validation Study

Completed

• Conditions: Hepatitis C
• Interventions: Device: HCV RNA detection with Genedrive assay; Device: HCV RNA detection with RealTime HCV

• Registration Number: NCT02992184
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-13
• Last Update Submitted: 2016-12-13
• Study First Posted: 2016-12-14
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 417

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	HCV RNA detection with RealTime HCV	189 controls
HCV patients	HCV RNA detection with Genedrive assay	228 HCV patients
control	HCV RNA detection with Genedrive assay	189 controls
HCV patients	HCV RNA detection with RealTime HCV	228 HCV patients

Primary Outcome Measures

Name	Time	Method
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).	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 Outcome Measures

Name	Time	Method
Diagnostic algorithm optimization	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.
Factors associated with false-positive of false-negative results	Pre-treatment	To identify factors associated with false-positive or false-negative results of the PoC assay.
Assess the inter-examiner reproducibility of the PoC assay.	Pre-treatment