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

Study Overview
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Brief Summary
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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)

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

Conditions
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Combined Point of Care Diagnostic of HIV, HBV and HCV

Intervention / Treatment
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* Diagnostic Test: MagIA IBC test in capillary blood
* Diagnostic Test: MagIA IBC test in other matrices


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>This study is single arm. | Diagnostic Test: MagIA IBC test in capillary blood<br>* After a finger prick, patients will be taken a drop of capillary drop. This drop will be used to perform the MagIA IBC test.<br>Diagnostic Test: MagIA IBC test in other matrices<br>* Blood samples will be taken and used to perform the MagIA IBC in veinous blood, serum and plasma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance measurement for the diagnostics of HIV, HBV or HCV | 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). | 24 hours | 
| Proportion with positive test result among participants with HIV, HBV or HCV | 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. | 24 hours | 
| Proportion with negative index test result among participants without HIV, HBV or HCV | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours | 
| Number of participants with study related adverse events. | Adverse events will be collected to assess safety of the device. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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point of care diagnostic, HIV, HCV, HBV