Status:
RECRUITING
Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Lead Sponsor:
MagIA Diagnostics
Collaborating Sponsors:
Institut Pasteur
Kenya Medical Research Institute
Conditions:
Multiplex Testing of HIV, HBV, HCV and Syphilis
HIV
Eligibility:
All Genders
18+ years
Brief 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 (...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Samples from patients below 18 years of age
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
2950 Patients enrolled
Trial Details
Trial ID
NCT07170748
Start Date
October 1 2025
End Date
March 1 2026
Last Update
September 25 2025
Active Locations (2)
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1
Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville
Abidjan, Côte d’Ivoire
2
Kenya Medical Research Institute (KEMRI)
Nairobi, Kenya