Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
Recruiting · NCT06623071 · Observational (researchers observe without assigning treatment) · Lead sponsor: CerbaXpert
View the official record on ClinicalTrials.gov →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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
2 locations listed.
- Cerba Xpert - Frépillon, Ile de Franace, France
- Cerballiance Chemin vert - France, Paris, France