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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Healthy; Hepatitis B; Diagnoses Disease

Treatments: Diagnostic Test: Demonstrator MAGIA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04109625

38RC.19.159

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Group 1: HBsAg negative, Anti HBc negative, Anti HBs negative, during a laboratory assay on serum
• Group 2: HBsAg negative, Anti HBc negative, Anti HBs positive, during a laboratory assay on serum
• Group 3: HBsAg negative, Anti HBc positive, Ab anti HBs positive or negative, during a laboratory assay on serum
• Group 4: HBsAg positive, Anti HBc positive, Anti HBs negative, during a laboratory assay on serum
• all: affiliated to social security or beneficiary of such a scheme

Exclusion criteria

• Infection by a confounding factor: HIV, HCV and / or HDV
• Protected person: Pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
• Exclusion period for other research studies involving the human person
• Annual threshold of allowances for participation in research involving the affected human person.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Non-immunized Hepatitis B

Experimental group

Description:

subjects non-immunized against hepatitis B (naive)

Treatment:

Diagnostic Test: Demonstrator MAGIA

Vaccine Hepatitis B

Experimental group

Description:

subjects vaccinated against hepatitis B

Treatment:

Diagnostic Test: Demonstrator MAGIA

Ongoing, Old or cured Hepatitis B

Experimental group

Description:

subjects with hepatitis B (old or cured)

Treatment:

Diagnostic Test: Demonstrator MAGIA