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

Sponsor
CerbaXpert
Study ID
NCT06623071
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Sep 2024
Primary completion
Mar 24, 2025
Completion
May 31, 2025

Study Design

Enrollment
45 participants (estimated)

Arms

  • Arm: Infected patients
    Patients infected with hepatitis B virus

Primary Outcome Measure

Commutability between serum and plasma hepatitis B viral load results with the ACCUPOWER HBV Quant Kit Bioneer Existation™FA 96/384 [ Time Frame: 4 months ]

Central Contacts

Related Studies