RECRUITINGOBSERVATIONAL
Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation™FA 96/384
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
The patient to be included in this study must be able to understand the purpose research, in order to give free and willing to sign a consent form.
- 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.
- Subject capable of understanding the aim of the research having given express free and willing to sign a consent form
- Subject affiliated to or beneficiary of a social security system
Who Should NOT Join This Trial:
Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative
• Subject participating in another clinical study
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
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.
* 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
Exclusion Criteria:
Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative
• Subject participating in another clinical study
Locations (2)
Cerba Xpert
Frépillon, Ile de Franace, France
Cerballiance Chemin vert
France, Paris, France