RecruitingNCT07170748

Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)

Clinical Performance Evaluation of MagIA In-vitro Diagnostic Medical Device for Multiplex Screening of Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C and Syphilis in Sub-Saharan Africa


Sponsor

MagIA Diagnostics

Enrollment

2,950 participants

Start Date

Jul 29, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from serum, plasma samples collected prospectively or retrospectively in Ivory Coast and Kenya.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new rapid blood test (MagIA) that can check for four infections at once — HIV, hepatitis B, hepatitis C, and syphilis. Researchers want to confirm that this multiplex test works accurately in real-world patient samples. **You may be eligible if...** - You are willing to provide a blood (serum or plasma) sample - Your sample tests positive for HIV, hepatitis B, hepatitis C, or syphilis — OR you are a blood donor, hospitalized patient, or member of a vulnerable population with a negative result - OR your sample contains potential interfering substances (e.g., you are pregnant, have other infections, or have high cholesterol or bilirubin levels) **You may NOT be eligible if...** - You are unable or unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville

Abidjan, Côte d’Ivoire

Kenya Medical Research Institute (KEMRI)

Nairobi, Kenya

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NCT07170748


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