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

May 17, 2022 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • Clinical research center CIC1406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of correlation
Time Frame: Day 0
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
Time Frame: day 0
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
Time Frame: day 0
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
Time Frame: day 0
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

MagIA Diagnostics

Investigators

  • Principal Investigator: Jean-Luc CRACOWSKI, MD, PhD, Grenoble Alps University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2019

Primary Completion (Actual)

May 13, 2022

Study Completion (Actual)

May 13, 2022

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC.19.159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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