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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

Start date

Jul 29, 2025

Status verified

Jan 2026

Primary completion

Apr 30, 2026

Completion

Apr 30, 2026

Study Design

Enrollment

2,950 participants (estimated)

Primary Outcome Measure

Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab [ Time Frame: Baseline ]

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