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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-21

Study Completion Date

2022-05-13

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.

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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.

Conditions

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Hepatitis B Healthy Diagnoses Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

3 parallel groups of 10 volunteers

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Non-immunized Hepatitis B

subjects non-immunized against hepatitis B (naive)

Group Type EXPERIMENTAL

Demonstrator MAGIA

Intervention Type DIAGNOSTIC_TEST

test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.

Vaccine Hepatitis B

subjects vaccinated against hepatitis B

Group Type EXPERIMENTAL

Demonstrator MAGIA

Intervention Type DIAGNOSTIC_TEST

test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.

Ongoing, Old or cured Hepatitis B

subjects with hepatitis B (old or cured)

Group Type EXPERIMENTAL

Demonstrator MAGIA

Intervention Type DIAGNOSTIC_TEST

test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.

Interventions

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Demonstrator MAGIA

test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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v0.1

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes