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

Healthy Clinical Trial

— DiVHeB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109625
• Other study ID #: 38RC.19.159
• Status: Completed
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: May 13, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 13, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diagnoses Disease
• Healthy
• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Diagnostic Test:
• Demonstrator MAGIA
test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.

Locations

Country	Name	City	State
France	Clinical research center CIC1406	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	magIA Diagnostics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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