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Clinical Trial 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).


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04904835
Study type Observational
Source Beckman Coulter, Inc.
Contact Juliane HEY, Dr
Phone +33 645 23 81 74
Email jhey@beckman.com
Status Recruiting
Phase
Start date October 15, 2019
Completion date May 2025

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