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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatitis B, Healthy, Diagnoses Disease

Intervention / Treatment
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* Diagnostic Test: Demonstrator MAGIA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 parallel groups of 10 volunteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-immunized Hepatitis B<br>subjects non-immunized against hepatitis B (naive) | Diagnostic Test: Demonstrator MAGIA<br>* test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.<br>* Other names: v0.1;|
| Experimental: Vaccine Hepatitis B<br>subjects vaccinated against hepatitis B | Diagnostic Test: Demonstrator MAGIA<br>* test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.<br>* Other names: v0.1;|
| Experimental: Ongoing, Old or cured Hepatitis B<br>subjects with hepatitis B (old or cured) | Diagnostic Test: Demonstrator MAGIA<br>* test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.<br>* Other names: v0.1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of correlation | To evaluate the feasibility estimated by correlation of the measurements (HBsAg, anti-HBs Ab, HBc-Ab) between the IVD-MD in point of care on capillary blood study and the laboratory results obtained on serum | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repeatability of the measurement HBsAg, anti-HBs Ab, HBc-Ab | Comparison of the repeatability of the measurement of HBsAg, anti-HBs Ab, HBc-Ab on 2 different fingers with the same device and the same batch of consumables with 2 different times | day 0 | 
| reproductibility of the measurement HBsAg, anti-HBs Ab, HBc-Ab | Comparison of the reproducibility of HBsAg, anti-HBs Ab, HBc-Ab via a test from 2 drops of blood on 2 different fingers with 2 different cartridges and two different readers | day 0 | 
| correlation according to status | Comparison of the correlation coefficients of the measurements between the IVD-MD in point of care and the biology automaton according to the different statuses | day 0 |