NCT06082336

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: MagIA Diagnostics · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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). Validation Phase is between Sept. 2024 and still ongoing.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MagIA IBC test in capillary blood	After a finger prick, patients will be taken a drop of capillary drop. This drop will be used to perform the MagIA IBC test.
DIAGNOSTIC_TEST	MagIA IBC test in other blood matrices	Blood samples will be taken and used to perform the MagIA IBC in veinous blood, serum and plasma, except for outdoor tested subjects

Timeline

• Start date: 2024-09-16
• Primary completion: 2025-08-26
• Completion: 2026-11-01
• First posted: 2023-10-13
• Last updated: 2026-02-03

Locations

2 sites across 1 country: France