HBVNCT04904835
Access HBV Assays - European Union (EU) Clinical Trial Protocol -
An observational study of HBV, run by Beckman Coulter, Inc. at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV
- What is being tested?
- Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
- Type of treatment
- Vaccines
- How many people
- 21,210 participants
- Where
- 5 sitesFrance
- Study dates
- 15 Oct 2019to 5 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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.)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie
Amiens, 80054
Etablissement Français du Sang (EFS) Hauts-de-France - Normandie
Bois-Guillaume, 76232
Cerba Xpert
Frépillon, 95740
Eurofins Biomnis
Ivry-sur-Seine, 94208
Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen
Rouen, 76031
About this study
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
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).
Read the 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).
- Conditions
- HBV
- Being tested
- Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
- 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)
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start15 Oct 2019
- Primary completion9 Dec 2025
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HBVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 21,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904835
- Sponsor's protocol ID
- DC-TR18-0408
- Other IDs
- HBV-EU-08-19
- Status last verified
- Apr 2026
- First submitted
- 18 May 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38838460
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04904835
- Acronym / sponsor ID
- DC-TR18-0408
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,210 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Unselected blood donors | – | Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysleftover 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 |
| Hospitalized patients | – | Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysLeftover samples to be tested by Access HBV serological marker assays and CE-marked predicate assays |
| Presumed HBsAg positive patients | – | Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysLeftover 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 |
| Patients having recovered from natural HBV infection, presumed Anti-HBs positive | – | Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysLeftover 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 |
| Patients having received HBV vaccination, presumed Anti-HBs positive | – | Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysLeftover 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 |
| Presumed Anti-HBc Total positive patients | – | Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysLeftover 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 |
| Presumed Anti-HBc IgM positive patients | – | Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysleft 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 |
| Presumed HBeAg positive patients | – | Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysLeftover 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 |
| Presumed Anti-HBe positive patients7 | – | Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysLeftover 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 |
| Patients with chronic HBV infection | – | Diagnostic Test: Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysLeftover samples to be tested by Access anti-HBc IgM assay and CE-marked predicate assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (1 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assaysAll 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. | Diagnostic test | 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 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 38838460Dzamitika 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV, run by Beckman Coulter, Inc. at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy measured as sensitivity and specificity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.