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

RECRUITINGSponsored by CerbaXpert
Actively Recruiting
SponsorCerbaXpert
Started2024-10-01
Est. completion2025-03-24
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06623071

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Hepatitis BLiver Disease

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