Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV, HCV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Côte d’Ivoire, Kenya
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Primary outcome measures
- Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab [Time frame: Baseline]
Secondary outcome measures (2)
- Evaluation of cross-reactivity with any potentially interfering substances or interferences with any co-infection or comorbidity [Time frame: Baseline]
- Evaluation of performance of MagIA H3S in determining on-going HCV infection [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Provide informed consent for participation in this study.
- Patient sample must meet at least one of the criteria below:
1\. 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Côte d’Ivoire · 1 center
- Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU — Abidjan
Kenya · 1 center
- Kenya Medical Research Institute (KEMRI) — Nairobi
Identifiers
NCT: NCT07170748 · MAGIA-H3S-EP-01