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

Last updated: December 2, 2024
Sponsor: Beckman Coulter, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis B

Treatment

Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays

Clinical Study ID

NCT04904835
DC-TR18-0408
HBV-EU-08-19
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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-HBspositive (i.e. Anti-HBs and Anti-HBc Total positive by CE-marked assays)

  • Patients having received HBV vaccination, presumed Anti-HBs positive (confirmedby testing at the time of enrollment, i.e. positive for Anti-HBs and negativefor 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/recentHBV 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

Exclusion Criteria:

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

Study Design

Total Participants: 21210
Treatment Group(s): 1
Primary Treatment: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
Phase:
Study Start date:
October 15, 2019
Estimated Completion Date:
May 31, 2026

Study 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).

Connect with a study center

  • Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie

    Amiens, 80054
    France

    Active - Recruiting

  • Etablissement Français du Sang (EFS) Hauts-de-France - Normandie

    Bois Guillaume, 76232
    France

    Site Not Available

  • Eurofins Biomnis

    Ivry-sur-Seine, 94208
    France

    Active - Recruiting

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

    Rouen, 76031
    France

    Active - Recruiting

  • Cerba Xpert

    St Ouen l'Aumone, 95310
    France

    Active - Recruiting

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