NCT04904835

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 21,210 (estimated)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-15
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2021-05-27
• Last updated: 2024-12-04

Locations

5 sites across 1 country: France