Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C (MAGICIEN)

Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of 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

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)

After a finger prick, patients will be taken a drop of capillary drop. This drop will be used to perform the MagIA IBC test.

ROC AUC will be calculated for HIV, HBV and HCV diagnostics. The ROC curve will be plotted with True Positive Rate (y-axis) against the False Positive Rate (x-axis).

Sensitivity - Number with positive result/(Number with positive or negative test result) among participants with HIV, HBC or HCV. HIV, HBV and HCV will be defined based on a reference standard.

Specificity - Number with negative results/(Number with positive or negative test result) among participants without HIV, HBC or HCV. HIV, HBV and HCV will be defined based on a reference standard.

Concordance of the diagnostic results obtained when it is performed in different matrices : Capillary blood, veinous blood, serum and plasma.

For each of the 3 assessments the Kappa Cohen Coefficient will be calculated for each intermatrice comparisons.

Inclusion Criteria: IC1. A Male or Female aged of at least 18 years IC2. A person taken care at Hôpital Européen de Marseille and responding to at least one of the following conditions: known or suspected having HIV infection known or suspected having HBV infection known or suspected having or having had HCV infection IC3. A person having given consent to participate the study, IC4. A person covered by a medical insurance. 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)