Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C (MAGICIEN)

January 30, 2026 updated by: MagIA Diagnostics

Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV antibodies (HIV-Ab), anti-HCV antibodies (HCV-Ab), and HBs antigens (HBs-Ag) in serum, plasma, venous blood and capillary blood. If not prescribed for the patient care, blood drawings, and finger pricks will be performed on the patient for the purpose of the clinical study.

The Study includes a Technical Adjustment Phase (to identify optimized acquisition parameters and to define the decision threshold for the diagnostic) followed by a Validation Phase (to validate the concordance between the matrices and to evaluate the Specificity and the Sensibility of the diagnostics).

Validation Phase is between Sept. 2024 and still ongoing.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

252

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
      • Perpignan, France, 66000
        • Recruiting
        • Centre Hospitalier de Perpignan - Equipe Mobile Hépatites
        • Contact:
        • Principal Investigator:
          • Andre-Jean REMY, Dr
    • France
      • Marseille, France, France, 13003
        • Completed
        • Hôpital Européen de Marseille

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

IC1. A Male or Female aged of at least 18 years

IC2. A person responding to one of the following conditions:

  • known having HIV infection
  • or known having HBV infection
  • or known or suspected having HCV infection with anti-HCV RDT positive. IC3. A person having given consent to participate the study, IC4. A person covered by a medical insurance or being enrolled during an outdoor testing campaign.

Exclusion Criteria:

EC1. A person for whom blood sampling would represent a risk, EC2. A person protected by law (minor, under guardianship or curatorship, childbearing, or breastfeeding female, hospitalized without consent, under administrative or judicial supervision)

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
This study is single arm.
Diagnostic test: MagIA IBC test in capillary blood
After a finger prick, patients will be taken a drop of capillary drop. This drop will be used to perform the MagIA IBC test.
Diagnostic test: MagIA IBC test in other blood matrices
Blood samples will be taken and used to perform the MagIA IBC in veinous blood, serum and plasma, except for outdoor tested subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Performance of the MagIA IBC test in determining the serological status of HIV infection, HCV infection (current infection only) and HBV infection
Time Frame: baseline
For each of the 3 diagnostics, the corresponding Endpoints are the Sensitivity (Se) and Specificity (Sp) of MagIA IBC.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance of the results delivered by MagIA IBC for HIV and HBV, on each of the selected matrices (i.e. serum, plasma, venous and capillary blood).
Time Frame: baseline
For HIV and HBV, the corresponding Endpoint is the Kappa coefficient calculated for each of the 6 concordance tables comparing the results in the selected matrices.
baseline
Adverse events of MagIA IBC test
Time Frame: 1 day
Adverse events will be collected to assess safety of the device.
1 day

Collaborators and Investigators

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

Sponsor

MagIA Diagnostics

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)

September 16, 2024

Primary Completion (Actual)

August 26, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAGIA-IBC-EP-01

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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