Actively Recruiting
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Led by MagIA Diagnostics · Updated on 2026-02-03
252
Participants Needed
2
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Known HIV infection or known HBV infection
- Known or suspected HCV infection with positive anti-HCV rapid test
- Provided consent to participate in the study
- Covered by medical insurance or enrolled during outdoor testing campaign
You will not qualify if you...
- Blood sampling would represent a risk for the person
- Person protected by law, including minors, individuals under guardianship or curatorship
- Pregnant or breastfeeding females
- Hospitalized without consent
- Under administrative or judicial supervision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hopital Européen de Marseille
Marseille, France, France, 13003
Completed
2
Centre Hospitalier de Perpignan - Equipe Mobile Hépatites
Perpignan, France, 66000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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