NCT04109625

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hepatitis B
• Healthy
• Diagnoses Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Demonstrator MAGIA	test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.

Timeline

• Start date: 2019-10-21
• Primary completion: 2022-05-13
• Completion: 2022-05-13
• First posted: 2019-09-30
• Last updated: 2022-05-24

Locations

1 site across 1 country: France