Clinical trial NCT04109625: Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening
Official title: Preliminary Validation of the Demonstrator of an In Vitro Diagnostic Device for Hepatitis B Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Healthy
Diagnoses Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: MagIA Diagnostics
First posted: 2019-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 parallel groups of 10 volunteers
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: feasibility of correlation
timeFrame: Day 0
Secondary outcomes:
measure: repeatability of the measurement HBsAg, anti-HBs Ab, HBc-Ab
timeFrame: day 0
measure: reproductibility of the measurement HBsAg, anti-HBs Ab, HBc-Ab
timeFrame: day 0
measure: correlation according to status
timeFrame: day 0
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinical research center CIC1406
Study officials:
affiliation: Grenoble Alps University Hospital
name: Jean-Luc CRACOWSKI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: