PoC-HCV Genedrive Viral Detection Assay Validation Study

ANRS, Emerging Infectious Diseases417 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

417

Conditions

Hepatitis C

Interventions

HCV RNA detection with Genedrive assayDEVICE

HCV RNA detection with RealTime HCVDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

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).

Time frame: pre-treatment

Secondary Outcomes

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.

Time frame: Pre-treatment

Factors associated with false-positive of false-negative results

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

Time frame: Pre-treatment

Assess the inter-examiner reproducibility of the PoC assay.

Time frame: Pre-treatment

Data from ClinicalTrials.gov

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