Actively Recruiting
AccuPower ae HBV Performance Evaluation Quant Kit Bioneer ExiStation trade; FA 96/384 Diagnostic Study for Hepatitis B Viral Load
Led by CerbaXpert · Updated on 2025-03-26
45
Participants Needed
2
Research Sites
9 weeks
Total Duration
On this page
Sponsors
C
CerbaXpert
Lead Sponsor
B
Bioneer Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the performance of the AccuPower ae HBV Quant Kit Bioneer ExiStation trade; FA 96/384 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 2017/746). 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 kit's 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.
CONDITIONS
Brief Title
Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the research purpose and give free informed consent
- Age over 18 years
- Presenting with a prescription for hepatitis B viral load determination or previously confirmed hepatitis B infection by approved tests
- Affiliated with or beneficiary of a social security system
You will not qualify if you...
- Adults under legal protection such as guardianship or deprived of liberty
- Currently participating in another clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months
Participants undergo testing to measure hepatitis B viral load using the AccuPower® HBV Quant Kit.
1 to 2 visits depending on testing schedule
Trial Site Locations
Total: 2 locations
1
Cerba Xpert
Frépillon, Ile de Franace, France, 95000
Not Yet Recruiting
2
Cerballiance Chemin vert
France, Paris, France, 75000
Actively Recruiting
Research Team
S
Sabrina KALI, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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