PoC-HCV Genedrive Viral Detection Assay Validation Study

Hepatitis C Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992184
• Other study ID #: ANRS HC POC VIRAL DETECTION
• Status: Completed
• Phase: N/A
• First received: December 12, 2016
• Last updated: December 13, 2016
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Device:
• HCV RNA detection with Genedrive assay

• HCV RNA detection with RealTime HCV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	EPISTEM

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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).	pre-treatment	No
Secondary	Diagnostic algorithm optimization	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.	Pre-treatment	No
Secondary	Factors associated with false-positive of false-negative results	To identify factors associated with false-positive or false-negative results of the PoC assay.	Pre-treatment	No
Secondary	Assess the inter-examiner reproducibility of the PoC assay.		Pre-treatment	No