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Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening — DiVHeB  

Healthy Clinical Trial

Official title:
Preliminary Validation of the Demonstrator of an In Vitro Diagnostic Device for Hepatitis B Screening

Clinical Trial Summary

The principal objective of the study is to perform a first step of technical adjustment and preliminary validation of a diagnostic test for hepatitis B (HBsAntigen, anti-HBs Antibody and anti-HBc Antibody) on capillary blood with the device under study in non-immunized subjects against hepatitis B, in subjects with hepatitis B, in subjects with old or cured hepatitis B and in hepatitis B vaccine recipients, compared with the values obtained with the reference technique of medical biology laboratory on serum. The analysis will be performed on the entire cohort.

Clinical Trial Description

The diagnosis of hepatitis B in precarious populations is often difficult. The use of a in vitro diagnosis-medical device in point of care could alleviate this difficulty. It would identify whether or not the subjects are infected with the virus, whether they are immunized or not. Then, depending on the results, the subjects could be directly vaccinated or referred to a laboratory of medical biology for confirmation / invalidation of the diagnosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04109625
Study type Interventional
Source University Hospital, Grenoble
Contact
Status Completed
Phase N/A
Start date October 21, 2019
Completion date May 13, 2022
View Details
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