PoC-HCV Genedrive Viral Detection Assay Validation Study

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.

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:

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