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