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)

MagIA Diagnostics

Status

Enrolling

Conditions

Combined Point of Care Diagnostic of HIV, HBV and HCV

Treatments

Diagnostic Test: MagIA IBC test in capillary blood

Diagnostic Test: MagIA IBC test in other blood matrices

Study type

Interventional

Funder types

Industry

Identifiers

NCT06082336

MAGIA-IBC-EP-01

Details and patient eligibility

About

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.

Enrollment

252 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

IC1. A Male or Female aged of at least 18 years

IC2. A person responding to one of the following conditions:

known having HIV infection
or known having HBV infection
or known or suspected having HCV infection with anti-HCV RDT positive. IC3. A person having given consent to participate the study, IC4. A person covered by a medical insurance or being enrolled during an outdoor testing campaign.

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)