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

Not Applicable

Completed

• Conditions: Healthy; Diagnoses Disease; Hepatitis B

• Registration Number: NCT04109625
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Study Start: 2019-10-21
• Status Verified: 2022-05
• Primary Completion: 2022-05-13
• Study Completion: 2022-05-13
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
feasibility of correlation	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

Secondary Outcome Measures

Name	Time	Method
reproductibility of the measurement HBsAg, anti-HBs Ab, HBc-Ab	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
correlation according to status	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
repeatability of the measurement HBsAg, anti-HBs Ab, HBc-Ab	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

Trial Locations

Locations (1)

Clinical research center CIC1406; 🇫🇷 Grenoble, France