Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MagIA IBC test in capillary blood, MagIA IBC test in other blood matrices.
- Who it may be relevant to
- Registry conditions: Combined Point of Care Diagnostic of HIV, HBV and HCV. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Clinical Performance of the MagIA IBC test in determining the serological status of HIV infection, HCV infection (current infection only) and HBV infection [Time frame: baseline]
Secondary outcome measures (2)
- Concordance of the results delivered by MagIA IBC for HIV and HBV, on each of the selected matrices (i.e. serum, plasma, venous and capillary blood). [Time frame: baseline]
- Adverse events of MagIA IBC test [Time frame: 1 day]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 2 centers
- Hopital Européen de Marseille — Marseille
- Centre Hospitalier de Perpignan - Equipe Mobile Hépatites — Perpignan
Identifiers
NCT: NCT06082336 · MAGIA-IBC-EP-01