Trials / Completed
CompletedNCT02992184
PoC-HCV Genedrive Viral Detection Assay Validation Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 417 (actual)
- Sponsor
- ANRS, Emerging Infectious Diseases · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HCV RNA detection with Genedrive assay | |
| DEVICE | HCV RNA detection with RealTime HCV |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2016-12-14
- Last updated
- 2016-12-14
Source: ClinicalTrials.gov record NCT02992184. Inclusion in this directory is not an endorsement.