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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Multiplex Testing of HIV, HBV, HCV and Syphilis Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Flaviviridae Infections Genital Diseases Gram-Negative Bacterial Infections HBV HCV HIV Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases Point of Care Testing RNA Virus Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Syphilis Treponemal Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville, Abidjan, Côte d’Ivoire

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

Samples from patients below 18 years of age

Treatment and study plan

Primary outcomes

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

Time frame: Baseline

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.

Secondary outcomes

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

Time frame: Baseline

Identification and collection of suspected and predefined cross-reacting or interfering substances (e.g. alcohol, tobacco, concomitant medication) and comorbidities (e.g. HTLV, EBV, CMV, HSV, malignancy).

Samples with inconclusive results from MagIA test and those with discordant results between MagIA and reference tests will be further examined for the presence of cross-reacting substances or underlying comorbidities that may influence the signal of the MagIA H3S test. Identified interfering substances will be documented through eCRF and additional analytical investigations will be conducted to confirm their impact.
Evaluation of performance of MagIA H3S in determining on-going HCV infection

Time frame: Baseline

Sensitivity, specificity, positive predictive value, and negative predictive value of the MagIA H3S HCV score to detect on-going HCV infection compared to the gold standard, considering only those with positive RNA viral load assay as positive for HCV.

Sponsors and collaborators

Lead sponsor

MagIA Diagnostics

Industry

Collaborators

Institut Pasteur
Kenya Medical Research Institute
Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire

Registry information

Official study title

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

Acronym: MAGICS IBCS

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 12, 2025
Registry last updated: Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed