PoC-HCV Genedrive Viral Detection Assay Validation Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02992184

Enrollment

417

Registered

2016-12-14

Start date

2016-09-30

Completion date

2016-12-31

Last updated

2016-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

HCV, Genedrive, Point of Care

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.

Interventions

DEVICEHCV RNA detection with Genedrive assay

DEVICEHCV RNA detection with RealTime HCV

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026