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New hepatitis b blood tests put to the test on 21,000 samples

NCT ID NCT04904835

Diagnosis Sponsor: Beckman Coulter, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study checked how well new blood tests (Access HBV assays) can detect hepatitis B infection. Researchers tested over 21,000 leftover blood samples from adults, including blood donors and hospital patients. The goal was to see if these tests are accurate compared to existing approved tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Access HBV serological marker assays (blood tests for hepatitis B)
What this could lead to
If successful, these tests could provide a reliable way to diagnose hepatitis B infection, helping doctors identify and manage the disease.
What could go wrong
This is a diagnostic accuracy study, not a treatment trial. The tests may not perform equally well in all populations or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

21,210 people

The number who actually took part.

Started

Oct 2019

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.)

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HBV

Contacts and locations

Locations

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

    Amiens, 80054, France

  • Cerba Xpert

    Frépillon, 95740, France

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

    Bois-Guillaume, 76232, France

  • Eurofins Biomnis

    Ivry-sur-Seine, 94208, France

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

    Rouen, 76031, France

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