Evaluation of a new diagnostic test for HIV, Hepatitis B, and Hepatitis C
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
This study is testing a new blood test to see if it can accurately detect HIV, Hepatitis B, and Hepatitis C in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | MagIA Diagnostics Industry-sponsored |
| Locations | 2 sites (Marseille, France and 1 other locations) |
| Trial ID | NCT06082336 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical performance of the MagIA IBC, a multiplex point-of-care diagnostic device designed to detect antibodies and antigens related to HIV, Hepatitis B, and Hepatitis C. It involves a prospective, cross-sectional approach where blood samples will be collected from participants to assess the test's accuracy and reliability. The study includes a Technical Adjustment Phase to optimize testing parameters and a Validation Phase to confirm the test's specificity and sensitivity across different blood matrices.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are being treated at Hôpital Européen de Marseille and have known or suspected infections of HIV, HBV, or HCV.
Not a fit: Patients for whom blood sampling poses a risk or those under legal protection, such as minors or individuals unable to provide consent, will not benefit from this study.
Why it matters
Potential benefit: If successful, this diagnostic test could provide rapid and accurate screening for HIV, Hepatitis B, and Hepatitis C, improving early detection and treatment outcomes.
How similar studies have performed: Other studies have shown success with similar point-of-care diagnostic approaches, indicating potential for effective screening methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: IC1. A Male or Female aged of at least 18 years IC2. A person responding to one of the following conditions: * known having HIV infection * or known having HBV infection * or known or suspected having HCV infection with anti-HCV RDT positive. IC3. A person having given consent to participate the study, IC4. A person covered by a medical insurance or being enrolled during an outdoor testing campaign. Exclusion Criteria: EC1. A person for whom blood sampling would represent a risk, EC2. A person protected by law (minor, under guardianship or curatorship, childbearing, or breastfeeding female, hospitalized without consent, under administrative or judicial supervision)
Where this trial is running
Marseille, France and 1 other locations
- Hopital Européen de Marseille — Marseille, France, France (Completed)
- Centre Hospitalier de Perpignan - Equipe Mobile Hépatites — Perpignan, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.