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

Primary Purpose

Hepatitis B, Healthy, Diagnoses Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Demonstrator MAGIA
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Clinical research center CIC1406

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Non-immunized Hepatitis B

Vaccine Hepatitis B

Ongoing, Old or cured Hepatitis B

Arm Description

subjects non-immunized against hepatitis B (naive)

subjects vaccinated against hepatitis B

subjects with hepatitis B (old or cured)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
September 20, 2019
Last Updated
May 17, 2022
Sponsor
University Hospital, Grenoble
Collaborators
MagIA Diagnostics
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1. Study Identification

Unique Protocol Identification Number
NCT04109625
Brief Title
Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening
Acronym
DiVHeB
Official Title
Preliminary Validation of the Demonstrator of an In Vitro Diagnostic Device for Hepatitis B Screening
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
MagIA Diagnostics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Healthy, Diagnoses Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 parallel groups of 10 volunteers
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-immunized Hepatitis B
Arm Type
Experimental
Arm Description
subjects non-immunized against hepatitis B (naive)
Arm Title
Vaccine Hepatitis B
Arm Type
Experimental
Arm Description
subjects vaccinated against hepatitis B
Arm Title
Ongoing, Old or cured Hepatitis B
Arm Type
Experimental
Arm Description
subjects with hepatitis B (old or cured)
Intervention Type
Diagnostic Test
Intervention Name(s)
Demonstrator MAGIA
Other Intervention Name(s)
v0.1
Intervention Description
test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.
Primary Outcome Measure Information:
Title
feasibility of correlation
Description
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
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
repeatability of the measurement HBsAg, anti-HBs Ab, HBc-Ab
Description
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
Time Frame
day 0
Title
reproductibility of the measurement HBsAg, anti-HBs Ab, HBc-Ab
Description
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
Time Frame
day 0
Title
correlation according to status
Description
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
Time Frame
day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc CRACOWSKI, MD, PhD
Organizational Affiliation
Grenoble Alps University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical research center CIC1406
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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