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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie, Amiens, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

Diagnostic accuracy measured as sensitivity and specificity

Time frame: 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

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2019
Primary completion: 2025
Study completion: 2026
First posted: May 27, 2021
Registry last updated: May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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