NCT07170748

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,950 (estimated)
• Sponsor: MagIA Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiplex Testing of HIV, HBV, HCV and Syphilis
• HIV
• HBV
• HCV
• Syphilis
• Point of Care Testing

Timeline

• Start date: 2025-07-29
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-09-12
• Last updated: 2026-02-02

Locations

2 sites across 2 countries: Côte d’Ivoire, Kenya