Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from serum, plasma samples collected prospectively or retrospectively in Ivory Coa
| Condition(s) | Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV, HCV, Syphilis, Point of Care Testing |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from serum, plasma samples collected prospectively or retrospectively in Ivory Coast and Kenya. |
| Who can participate | Inclusion Criteria: * Provide informed consent for participation in this study. * Patient sample must meet at least one of the criteria below: 1\. Positive samples (serum or plasma) from individuals who meet at least one of the following conditions: * HIV-1 Ab positive * HIV-2 Ab positive * HCV-Ab positive * HBsAg positive * Positive for at least TPHA, with those positive for both TPHA and VDRL ideally included 2. Negative samples (serum or plasma) from individuals who meet at least one of the following conditions: * Blood donors * Hospitalized patients or individuals coming to the clinic * Vulnerable populations (such as: drug users, prison population, ...) 3. Negative samples (serum or plasma) containing potential interfering substances from individuals who meet at least one of the follo |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | MagIA Diagnostics |
| Locations | Abidjan, Côte d’Ivoire; Nairobi, Kenya |
| Start date | 2025-07-29 |
| NCT ID | NCT07170748 |
| Official listing | https://clinicaltrials.gov/study/NCT07170748 |