PoC-HCV Genedrive Viral Detection Assay Validation Study

ANRS, Emerging Infectious Diseases

Status

Completed

Conditions

Hepatitis C

Treatments

Device: HCV RNA detection with Genedrive assay

Device: HCV RNA detection with RealTime HCV

Study type

Observational

Funder types

Other

Identifiers

NCT02992184

ANRS HC POC VIRAL DETECTION

Details and patient eligibility

About

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.

Enrollment

417 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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