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

NCT ID NCT04904835

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

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.

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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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