Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGOBSERVATIONAL

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

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: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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.) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.)

Treatments Being Tested

DIAGNOSTIC_TEST

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

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.

Locations (5)

Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie
Amiens, France
Etablissement Français du Sang (EFS) Hauts-de-France - Normandie
Bois-Guillaume, France
Eurofins Biomnis
Ivry-sur-Seine, France
Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen
Rouen, France
Cerba Xpert
Saint-Ouen-l'Aumône, France