Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Recruiting · NCT06082336 · Interventional (participants receive a specific treatment) · Lead sponsor: MagIA Diagnostics
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 it is running
2 locations listed.
- Centre Hospitalier de Perpignan - Equipe Mobile Hépatites - Perpignan, France
- Hopital Européen de Marseille - Marseille, France, France