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

NCT07170748 | Recruiting

• 1 other identifier: MAGIA-H3S-EP-01
• Study Type: observational
• Target: 2,950
• Locations: 2 countries
• Sites: 2

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 (HIV), Hepatitis B and C and Syphilis) from serum, plasma samples collected prospectively or retrospectively in Ivory Coast and Kenya.

Conditions

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

Keywords

point of care test; HIV; HBV; HCV; Syphilis; multiplex testing

Outcome Measures

Primary Outcomes (1)

• Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab

  Diagnostic sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) of the MagIA H3S device for detecting each of the four markers: HIV-Ab, HCV-Ab, HBsAg, and TP-Ab, compared to reference standard testing.

  Baseline

Secondary Outcomes (2)

• Evaluation of cross-reactivity with any potentially interfering substances or interferences with any co-infection or comorbidity

  Baseline

• Evaluation of performance of MagIA H3S in determining on-going HCV infection

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of blood samples from individuals recruited from those seeking viral load testing and diagnostic services for HIV, HBV, HCV, and syphilis or from individuals belonging to one of the target populations of the study

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

You may not qualify if:

• Samples from patients below 18 years of age

Sponsors & Collaborators

• MagIA Diagnostics: lead
• Institut Pasteur: collaborator
• Kenya Medical Research Institute: collaborator
• Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire: collaborator

Study Sites (2)

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

Abidjan, Côte d’Ivoire

RECRUITING

Kenya Medical Research Institute (KEMRI)

Nairobi, Kenya

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis B; Hepatitis C; Syphilis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: July 29, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1); CÔ (1)