Actively Recruiting
Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
Led by CerbaXpert · Updated on 2025-03-26
45
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
Sponsors
C
CerbaXpert
Lead Sponsor
B
Bioneer Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
As part of the CE marking of a hepatitis B diagnostic kit, the South Korean manufacturer Bioneer wishes to set up a performance study in France in accordance with the IVDR (RE 2017/746). Cerba Xpert CRO of the Cerba Healthcare group promoted this performance study by setting up a prospective collection of blood samples from patients with hepatitis B virus and whose viral load is positive. This prospective collection will be carried out in 3 laboratories of the Cerba Healthcare group.
CONDITIONS
Official Title
Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
Who Can Participate
Eligibility Criteria
You may qualify if you...
The patient to be included in this study must be able to understand the purpose research, in order to give free and informed consent.
-
Subject aged over 18
-
Subject presenting himself at the investigation center and responding to one of these two criteria:
- Subject presenting with a prescription for determination HBV viral load
- Subject with previously confirmed HBV infection by CE marked tests.
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Subject capable of understanding the aim of the research having given express free and informed consent
-
Subject affiliated to or beneficiary of a social security system
You will not qualify if you...
Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative
• Subject participating in another clinical study
AI-Screening
AI-Powered Screening
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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.
CONTACT
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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