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

NCT06623058 | Not Yet Recruiting

• 1 other identifier: 2024-A01285-42
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

As part of the CE marking of a hepatitis C 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 suffering from the virus hepatitis C and whose viral load is positive. This prospective collection will be carried out in 4 laboratories of the Cerba Healthcare group.

Conditions

HEPATITIS C (HCV)

Outcome Measures

Primary Outcomes (1)

• Commutability between serum and plasma hepatitis C viral load results with the ACCUPOWER HCV 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 ® HCV 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 with hepatitis C virus

Infected patients with hepatitis C 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 C virus

You may qualify if:

• The patient to be included in this study must be able to understand the purpose of the research, in order to to give free and informed consent.
• Subject aged over 18
• Subject presenting at the investigation center and meeting one of these two criteria:
• Subject presenting with a prescription for HCV viral load determination
• Subject whose HCV infection is previously confirmed by CE marked tests.
• Subject capable of understanding the purpose 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 a clinical study/receiving investigational treatment

Sponsors & Collaborators

• CerbaXpert: lead
• Bioneer Corporation: collaborator

Study Sites (1)

Cerba Xpert

Frépillon, Île-de-France Region, 95000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample frome hepatitis C infected patients

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Sabrina Kali, Dr

CONTACT

33762376831; skali@cerbaresearch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• 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: January 31, 2025
• Study Completion: May 30, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)