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

Not Applicable

Recruiting

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

• Registration Number: NCT06082336
• Lead Sponsor: MagIA Diagnostics

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-23
• Status Verified: 2023-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 252

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion with negative index test result among participants without HIV, HBV or HCV	24 hours	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.
Performance measurement for the diagnostics of HIV, HBV or HCV	24 hours	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).
Proportion with positive test result among participants with HIV, HBV or HCV	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Concordance of the diagnostic results obtained when it is performed in different matrices : Capillary blood, veinous blood, serum and plasma.	24 hours	For each of the 3 assessments the Kappa Cohen Coefficient will be calculated for each intermatrice comparisons.
Number of participants with study related adverse events.	1 day	Adverse events will be collected to assess safety of the device.

Trial Locations

Locations (1)

Hopital Européen de Marseille; 🇫🇷 Marseille, France