Actively Recruiting
Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Led by MagIA Diagnostics · Updated on 2026-02-02
2950
Participants Needed
2
Research Sites
35 weeks
Total Duration
On this page
Sponsors
M
MagIA Diagnostics
Lead Sponsor
I
Institut Pasteur
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent for participation in this study.
- Patient sample must be positive for at least one: HIV-1 Ab, HIV-2 Ab, HCV-Ab, HBsAg, or syphilis antibodies (TPHA and ideally VDRL).
- Negative samples from blood donors, hospitalized patients, clinic visitors, or vulnerable populations such as drug users or prison populations.
- Negative samples with potential interfering substances from pregnant women or individuals infected with hepatitis A, hepatitis E, tuberculosis, gonorrhoea, chlamydia, influenza, or Covid-19.
- Negative samples with high IgG levels, high rheumatoid factor (>15 IU/mL), high cholesterol (>0.24 md/dL), high bilirubin (>0.25 mg/mL), high triglycerides (>500 mg/dL), or a diagnosis of cancer.
You will not qualify if you...
- Samples from patients below 18 years of age.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville
Abidjan, Côte d’Ivoire
Actively Recruiting
2
Kenya Medical Research Institute (KEMRI)
Nairobi, Kenya
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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