Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
ConditionHepatitis B
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCerbaXpert
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.
Eligibility criteria
Qualifiers
Subject aged over 18
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Not listed
Trial groups
45 Participants
are grouped into 1 trial groupSponsors and collaborators
CerbaXpert
Lead sponsor
Bioneer Corporation
Collaborator
Source ClinicalTrials.gov