NCT06082336Terminated
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV antibodies (HIV-Ab), anti-HCV antibodies (HCV-Ab), and HBs antigens (HBs-Ag) in serum, plasma, venous blood and capillary blood. If not prescribed for the patient care, blood drawings, and finger pricks will be performed on the patient for the purpose of the clinical study. The Study includes a Technical Adjustment Phase (to identify optimized acquisition parameters and to define the decision threshold for the diagnostic) followed by a Validation Phase (to validate the concordance between the matrices and to evaluate the Specificity and the Sensibility of the diagnostics). Validation Phase is between Sept. 2024 and still ongoing.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 2 Oct 2023
- Start date
- 16 Sept 2024
- Primary completion date
- 24 Mar 2026
- Lead sponsor
- MagIA Diagnostics
- Diseases
- Hepatitis B, HIV
- NCT number
- NCT06082336
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Européen de Marseille Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Centre Hospitalier de Perpignan - Equipe Mobile Hépatites Coordinator of this site? Confirm its status | Perpignan | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.