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

HBV Clinical Trial

Official title:

Evaluation of the Beckman Coulter Access Hepatitis B Virus (HBV) Serological Marker Assays as an Aid in the Diagnosis of HBV Infection: EU Clinical Trial Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904835
• Other study ID #: DC-TR18-0408
• Secondary ID: HBV-EU-08-19
• Status: Recruiting
• Start date: October 15, 2019
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: Beckman Coulter, Inc.
• Contact: Juliane HEY, Dr
• Phone: +33 645 23 81 74
• Email: jhey[@]beckman.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21210
• Est. completion date: May 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• HBV
• Hepatitis B

Intervention

Diagnostic Test:
• Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy measured as sensitivity and specificity	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	Baseline