PoC-HCV Genedrive Viral Detection Assay Validation Study

Study Overview
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Brief Summary
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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.

Conditions
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Hepatitis C

Intervention / Treatment
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* Device: HCV RNA detection with Genedrive assay
* Device: HCV RNA detection with RealTime HCV


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCV patients<br>228 HCV patients | Device: HCV RNA detection with Genedrive assay<br> <br> * Other names: HCV RNA detection with Point of Care assay;Device: HCV RNA detection with RealTime HCV<br> <br> * Other names: HCV RNA detection with RT-PCR assay;|
| control<br>189 controls | Device: HCV RNA detection with Genedrive assay<br> <br> * Other names: HCV RNA detection with Point of Care assay;Device: HCV RNA detection with RealTime HCV<br> <br> * Other names: HCV RNA detection with RT-PCR assay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Assess the inter-examiner reproducibility of the PoC assay. |  | Pre-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, Genedrive, Point of Care