Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | This study is single arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagIA IBC test in capillary blood | Diagnostic Test | After a finger prick, patients will be taken a drop of capillary drop. This drop will be used to perform the MagIA IBC test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance of the MagIA IBC test in determining the serological status of HIV infection, HCV infection (current infection only) and HBV infection | For each of the 3 diagnostics, the corresponding Endpoints are the Sensitivity (Se) and Specificity (Sp) of MagIA IBC. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | baseline |
Not provided
Inclusion Criteria:
IC1. A Male or Female aged of at least 18 years
IC2. A person responding to one of the following conditions:
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Européen de Marseille | Completed | Marseille | France | 13003 | France | |
| Centre Hospitalier de Perpignan - Equipe Mobile Hépatites |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MagIA IBC test in other blood matrices | Diagnostic Test | Blood samples will be taken and used to perform the MagIA IBC in veinous blood, serum and plasma, except for outdoor tested subjects |
|
| Adverse events of MagIA IBC test |
Adverse events will be collected to assess safety of the device. |
| 1 day |
| Recruiting |
| Perpignan |
| 66000 |
| France |
|
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided