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

Recruiting now

Conditions studied: Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV, HCV, Syphilis, Point of Care Testing

In brief

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 facts

Study ID

NCT07170748

Run by

MagIA Diagnostics

People needed

2950

Starts

2025-07-29

Expected to finish

2026-04-01

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provide informed consent for participation in this study.
• Patient sample must meet at least one of the criteria below:
• 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

You may not qualify if…

• Samples from patients below 18 years of age

Where it is running

• Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville — Abidjan, Côte d’Ivoire (enrolling)
• Kenya Medical Research Institute (KEMRI) — Nairobi, Kenya (enrolling)

Full record on ClinicalTrials.gov

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