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RECRUITING
NCT04904835

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

Sponsor: Beckman Coulter, Inc.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

21210

Start Date

2019-10-15

Completion Date

2026-05

Last Updated

2024-12-04

Healthy Volunteers

No

Conditions

Interventions

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