Evaluation of Accupowerae HBV Quant Kit Bioneer ExiStationtrade FA 96384 for Measuring Hepatitis B Viral Load in Adults

What this Trial Is About

This research aims to evaluate the performance of the AccuPowerae HBV Quant Kit Bioneer ExiStationtrade FA 96384 diagnostic kit for hepatitis B virus HBV in France. Hepatitis B is a liver infection caused by the HBV virus, which can lead to chronic liver disease in some individuals. The study is conducted as part of the CE marking process to meet European regulatory standards IVDR RE 2017746. The trial involves patients with hepatitis B who have a positive viral load, focusing on how well the kit measures HBV DNA in blood samples. The study involves collecting blood samples prospectively from patients with hepatitis B at three Cerba Healthcare group laboratories in France. The AccuPower kit will be tested on both serum and plasma samples from these patients. The study does not involve treatment but focuses on diagnostic performance comparison. The main goal is to assess the consistency and reliability of viral load results between serum and plasma using this PCR-based diagnostic tool. Participants will provide blood samples as part of their routine care, and their viral loads will be measured using the AccuPower kit. Researchers will compare the viral load results from serum and plasma over a four-month period to evaluate the kits performance. There are no additional treatments or interventions. Participant safety and informed consent are ensured, and the study is observational. Total participation time depends on sample collection and routine monitoring.

Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384