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

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

Not Recruiting
18 years and older
Male
Phase N/A

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Overview

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)

Eligibility

Inclusion Criteria:

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

        IC2. A person taken care at Hôpital Européen de Marseille and responding to at least one of
        the following conditions:
          -  known or suspected having HIV infection
          -  known or suspected having HBV infection
          -  known or suspected having or having had HCV infection IC3. A person having given
             consent to participate the study, IC4. A person covered by a medical insurance.
        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 details
    Combined Point of Care Diagnostic of HIV
    HBV and HCV

NCT06082336

MagIA Diagnostics

30 January 2026

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