Access HBV Assays - European Union (EU) Clinical Trial Protocol -

Recruiting

• Conditions: HBV

• Registration Number: NCT04904835
• Lead Sponsor: Beckman Coulter, Inc.

Brief Summary

The objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer.

The study will involve a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Hepatitis B Virus assays as required per the European Union Common Technical Specification. All samples collected will be anonymized or pseudo-anonymised, leftover, remnant samples. Pseudo-anonymised collection of samples will require documented patient consent (oral or written).

Detailed Description

Sensitivity to final status on presumed HBV serological marker positive subjects will be calculated. Specificity will be calculated from hospitalized patients and blood donors specimens. False Initial Reactive Rate will be calculated on fresh hospitalized patient samples for Access HBsAg assay only (Qualitative).

Study Timeline

• Study Start: 2019-10-15
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-12
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21210

Inclusion Criteria

• Subject aged ≥ 18 years,

• Subject who has provided consent (oral or written) or sample collected under waiver

• With sufficient volume to perform clinical trial testing

• And belonging to one of the following enrollment groups:

  • Unselected blood donors
  • Hospitalized patients
  • Presumed HBsAg positive patients by Confirmatory testing of a CE-marked assay
  • Patients having recovered from natural HBV infection, presumed Anti-HBs positive (i.e. Anti-HBs and Anti-HBc Total positive by CE-marked assays)
  • Patients having received HBV vaccination, presumed Anti-HBs positive (confirmed by testing at the time of enrollment, i.e. positive for Anti-HBs and negative for Anti-HBc by CE-marked assays).
  • Presumed Anti-HBc Total positive patients by a CE-marked assay
  • Presumed Anti-HBc IgM positive patients by a CE-marked assay with acute/recent HBV infection 8
  • Presumed HBeAg positive patients by a CE-marked assay
  • Presumed Anti-HBe positive patients by a CE-marked assay
  • Patients with chronic HBV infection

Exclusion Criteria

• Samples from subjects already included in the study* (* Patient can be included only once per HBV marker study, but can potentially be enrolled for several separate HBV marker studies.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy measured as sensitivity and specificity	Baseline	The endpoint will be diagnostic accuracy measured as sensitivity and specificity of Access HBV serological assays compared to sample status determined by specific testing algorithm for each HBV marker

Trial Locations

Locations (5)

Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie; 🇫🇷 Amiens, France

Etablissement Français du Sang (EFS) Hauts-de-France - Normandie; 🇫🇷 Bois Guillaume, France

Eurofins Biomnis; 🇫🇷 Ivry-sur-Seine, France

Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen; 🇫🇷 Rouen, France

Cerba Xpert; 🇫🇷 St Ouen l'Aumone, France