NCT07170748Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2950 (estimated)
- First submitted
- 5 Sept 2025
- Start date
- 29 Jul 2025
- Primary completion date
- Apr 2026
- Lead sponsor
- MagIA Diagnostics
- Diseases
- Hepatitis B, HIV
- NCT number
- NCT07170748
What you commit to
- Study type: Observational
- Planned participants: 2950
- From 29 Jul 2025 to the primary completion date, Apr 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Samples from patients below 18 years of age
Who the study is looking for
- Provide informed consent for participation in this study.
- Patient sample must meet at least one of the criteria below:
- 1\. Positive samples (serum or plasma) from individuals who meet at least one of the following conditions:
- HIV-1 Ab positive
- HIV-2 Ab positive
- HCV-Ab positive
- HBsAg positive
- Positive for at least TPHA, with those positive for both TPHA and VDRL ideally included 2. Negative samples (serum or plasma) from individuals who meet at least one of the following conditions:
- Blood donors
- Hospitalized patients or individuals coming to the clinic
- Vulnerable populations (such as: drug users, prison population, ...) 3. Negative samples (serum or plasma) containing potential interfering substances from individuals who meet at least one of the following conditions:
- Being a pregnant woman
- Infected with at least one of the following viruses or bacteria: hepatitis A virus (HAV), hepatitis E virus (HEV), tuberculosis (TB), gonorrhoea, chlamydia, influenza virus, Covid-19
- Presenting any of the following criteria:
- High IgG levels
- High rheumatoid factor (\>15 IU/mL)
- High cholesterol levels (\>0.24 md/dL)
- High bilirubin levels (\>0.25 mg/mL)
- High triglyceride levels (\>500 mg/dL)
- Diagnosis of cancer
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville Coordinator of this site? Confirm its status | Abidjan | Côte d’Ivoire | Recruiting |
| Kenya Medical Research Institute (KEMRI) Coordinator of this site? Confirm its status | Nairobi | Kenya | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.