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

Last updated: January 30, 2026
Sponsor: MagIA Diagnostics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disorders

Hepatitis

Hepatitis B

Treatment

MagIA IBC test in other blood matrices

MagIA IBC test in other matrices

MagIA IBC test in capillary blood

Clinical Study ID

NCT06082336
MAGIA-IBC-EP-01
  • Ages > 18
  • Male
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 personhaving given consent to participate the study, IC4. A person covered by a medicalinsurance or being enrolled during an outdoor testing campaign.

Exclusion

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 Design

Total Participants: 252
Treatment Group(s): 3
Primary Treatment: MagIA IBC test in other blood matrices
Phase:
Study Start date:
September 16, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Hopital Européen de Marseille

    Marseille 2995469, France 13003
    France

    Completed

  • Hopital Européen de Marseille

    Marseille, 13003
    France

    Site Not Available

  • Centre Hospitalier de Perpignan - Equipe Mobile Hépatites

    Perpignan 2987914, 66000
    France

    Active - Recruiting

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