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

NCT04109625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-05-24

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Demonstrator MAGIA

test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.

Sponsors & Collaborators

  • MagIA Diagnostics

    collaborator INDUSTRY

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Jean-Luc CRACOWSKI, MD, PhD · Grenoble Alps University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2022-05-13
Completion
2022-05-13

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04109625 on ClinicalTrials.gov