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

NCT06623071 | Recruiting

• 1 other identifier: 2024-A01285-43
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatitis B

Keywords

HBV

Outcome Measures

Primary Outcomes (1)

• Commutability between serum and plasma hepatitis B viral load results with the ACCUPOWER HBV Quant Kit Bioneer Existation™FA 96/384

  The submitted protocol is carried out as part of a 'commutability' study, that is to say for Compare two matrix types on the Accupower ® HBV Quant Kit Bioneer Existence™FA 96/384. Indeed, for these two matrices to be claimed in the IFU of the kit it is necessary to prove that the two matrices give the same result. The planned size of the evaluable cohort is 45 patients included over a period of 4 month. This size is justified by the recommendations of the applicable CLSI EP09 guide. This guide details the use of several mathematical models that guarantee robust analysis even on a small cohort size. The operating methodology of the results is detailed below, taken from the recommendations of the CLSI EP09 guide

  4 months

Study Arms (1)

Infected patients

Patients infected with hepatitis B virus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infected patients with hepatitis B virus

You may qualify if:

• 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

You may not qualify if:

• Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative
• Subject participating in another clinical study

Sponsors & Collaborators

• CerbaXpert: lead
• Bioneer Corporation: collaborator

Study Sites (2)

Cerba Xpert

Frépillon, Ile de Franace, 95000, France

NOT YET RECRUITING

Cerballiance Chemin vert

France, Paris, 75000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Evaluation performance in vitro medical device study

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Sabrina KALI, Dr.

CONTACT

33762376831; kali.rinasab@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion: March 24, 2025
• Study Completion: May 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)