Combined Point of Care Diagnostic of HIV, HBV and HCV
Conditions
Keywords
point of care diagnostic, HIV, HCV, HBV
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). Validation Phase is between Sept. 2024 and still ongoing.
Interventions
DIAGNOSTIC_TESTMagIA 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_TESTMagIA 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
Sponsors
MagIA Diagnostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance of the MagIA IBC test in determining the serological status of HIV infection, HCV infection (current infection only) and HBV infection | baseline | For each of the 3 diagnostics, the corresponding Endpoints are the Sensitivity (Se) and Specificity (Sp) of MagIA IBC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | baseline | For HIV and HBV, the corresponding Endpoint is the Kappa coefficient calculated for each of the 6 concordance tables comparing the results in the selected matrices. |
| Adverse events of MagIA IBC test | 1 day | Adverse events will be collected to assess safety of the device. |
Countries
France
Outcome results
None listed