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

NCT04904835 | Completed

• 2 other identifiers: DC-TR18-0408HBV-EU-08-19
• Study Type: observational
• Target: 21,210
• Locations: 1 country
• Sites: 5

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).

Conditions

HBV

Keywords

Hepatitis B surface Antigen (HBsAg); Total hepatitis B core Antibody (HBcT); Hepatitis B e Antigen (HBeAg); Hepatitis B e Antibody (HBeAb); Hepatitis B surface Antibody (HBsAb); IgM Antibody to hepatitis B core Antigen (HBc IgM)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (10)

Unselected blood donors

leftover samples from unselected blood donors from at least 2 donation centers. Leftover samples to be tested by Access HBV serological marker assays and CE-marked (european compliance marked) predicate assays

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

Hospitalized patients

Leftover samples to be tested by Access HBV serological marker assays and CE-marked predicate assays

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

Presumed HBsAg positive patients

Leftover samples from patients at different stages of HBV infection (acute and chronic, minimum 10 per stage of infection), HBsAg positive by a Confirmatory testing of a CE-marked assay, including ≥ 25 "same day" fresh samples (tested ≤1 day after sampling), and minimum 20 high positive samples (\>26 IU/mL) and minimum 20 samples in the cut-off range. If not enough samples in the cut-off range are obtained during the clinical trial, additional HBsAg specimens in the cut-off range will be tested by Research \&Development to fit with Common Technical Specification requirements. Leftover samples to be tested by Access HBsAg assays and CE-marked predicate assays

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

Patients having recovered from natural HBV infection, presumed Anti-HBs positive

Leftover samples from Patients positive for Anti-HBs and Anti-HBc Total by CE-marked assays. Target is to have at least ¾ of them recovered without HBV antiviral treatment. Leftover samples to be tested by Access anti-HBs assay and CE-marked predicate assays

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

Patients having received HBV vaccination, presumed Anti-HBs positive

Leftover samples Confirmed as vaccinated by testing at the time of enrollment (i.e. positive for Anti-HBs and negative for Anti-HBc by CE-marked assays).Leftover samples to be tested by Access anti-HBs assay and CE-marked predicate assays

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

Presumed Anti-HBc Total positive patients

Leftover samples from Patients at different stage of infection (acute, chronic or recovered, minimum 10 per stage of infection) positive for Anti-HBc Total by a CE-marked assay, including ≥ 25 "same day" fresh samples (tested ≤1 day after sampling). Leftover samples to be tested by Access anti-HBc Total and CE-marked predicate assays

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

Presumed Anti-HBc IgM positive patients

left over samples from Patients with acute/recent HBV infection, positive for Anti-HBc IgM by a CE-marked assay. Leftover samples to be tested by Access anti-HBc IgM assay and CE-marked predicate assays

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

Presumed HBeAg positive patients

Leftover samples from Patients at different stages of infection (acute and chronic, minimum 5 per stage of infection), positive for HBeAg by a CE-marked assay. Leftover samples to be tested by Access HBeAg assay and CE-marked predicate assays

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

Presumed Anti-HBe positive patients7

Leftover samples from Patients at different stages of infection (chronic and recovered, minimum 5 per stage of infection), positive for Anti-HBe by a CE-marked assay. Leftover samples to be tested by Access anti-HBe assay and CE-marked predicate assays

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

Patients with chronic HBV infection

Leftover samples to be tested by Access anti-HBc IgM assay and CE-marked predicate assay

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

Interventions

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.

Hospitalized patients; Patients having received HBV vaccination, presumed Anti-HBs positive; Patients having recovered from natural HBV infection, presumed Anti-HBs positive; Patients with chronic HBV infection; Presumed Anti-HBc IgM positive patients; Presumed Anti-HBc Total positive patients; Presumed Anti-HBe positive patients7; Presumed HBeAg positive patients; Presumed HBsAg positive patients; Unselected blood donors

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

The test population includes : 1. 16,400 Unselected blood donors from at least 2 donation centers 2. 2,700 Hospitalized patients 3. 450 Presumed HBsAg positive patients 4. 150 Patients having recovered from natural HBV infection, presumed Anti-HBs positive 5. 300 Patients having received HBV vaccination, presumed Anti-HBs positive 6. 450 Presumed Anti-HBc Total positive patients 7. 220 Presumed Anti-HBc IgM positive patients 8-220 Presumed HBeAg positive patients 9- 220 Presumed Anti-HBe positive patients 10- 100 Patients with chronic HBV infection TOTAL n=21,210

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (5)

Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie

Amiens, 80054, France

Location

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

Bois-Guillaume, 76232, France

Location

Cerba Xpert

Frépillon, 95740, France

Location

Eurofins Biomnis

Ivry-sur-Seine, 94208, France

Location

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

Rouen, 76031, France

Location

Related Publications (1)

• Dzamitika S, Boulaire FL, Coignard C, Vincent C, Plantier JC, Lemee V, Greaume S, Voisin I, Brochot E, Herpe YE, Demirdjian G, Karagueuzian M, Afful D, Bayoud R, Hey J. Performance evaluation of the Access anti-HBc Total assay on the DxI 9000 Access Immunoassay Analyzer. Diagn Microbiol Infect Dis. 2024 Sep;110(1):116303. doi: 10.1016/j.diagmicrobio.2024.116303. Epub 2024 Apr 20.

  PMID: 38838460 DERIVED

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 27, 2021
• Study Start: October 15, 2019
• Primary Completion: December 9, 2025
• Study Completion: March 5, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)