Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation™FA 96/384
CerbaXpert
45 participants
Oct 1, 2024
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria2
- Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative
- Subject participating in another clinical study
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Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06623071