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Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384
Sponsor: CerbaXpert
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.
Official title: Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation™FA 96/384
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
45
Start Date
2024-10-01
Completion Date
2025-05-31
Last Updated
2025-03-26
Healthy Volunteers
No
Conditions
Locations (2)
Cerba Xpert
Frépillon, Ile de Franace, France
Cerballiance Chemin vert
France, Paris, France