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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
Sponsor: MagIA Diagnostics
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.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
252
Start Date
2024-09-16
Completion Date
2026-11
Last Updated
2026-02-03
Healthy Volunteers
Yes
Interventions
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.
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
Locations (2)
Hopital Européen de Marseille
Marseille, France, France
Centre Hospitalier de Perpignan - Equipe Mobile Hépatites
Perpignan, France