RecruitingNCT07170748

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

Sponsor

MagIA Diagnostics

Enrollment

2,950 participants

Start Date

Jul 29, 2025

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria20

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

Exclusion Criteria1

Samples from patients below 18 years of age

Locations(2)

Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville

Abidjan, Côte d’Ivoire

Kenya Medical Research Institute (KEMRI)

Nairobi, Kenya

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NCT07170748

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