Clinical Performance Evaluation of MagIA In-vitro Diagnostic Medical Device for Multiplex Screening of HIV, Hepatitis B, Hepatitis C, and Syphilis in Sub-Saharan Africa

What this Trial Is About

Researchers are evaluating the clinical performance of the MagIA H3S, an In-Vitro Diagnostics Medical Device designed to detect multiple infections including HIV, Hepatitis B, Hepatitis C, and Syphilis. This observational study focuses on samples collected both prospectively and retrospectively from individuals in Ivory Coast and Kenya. The aim is to assess how well this multiplex point-of-care test identifies these infections in various populations. The study uses serum or plasma samples from different groups, including those with positive results for HIV-1, HIV-2, HCV, Hepatitis B surface antigen, or syphilis antibodies, as well as negative samples from blood donors, hospitalized patients, and vulnerable populations like drug users and prisoners. Additionally, negative samples containing potential interfering substances, such as samples from pregnant women or individuals with other infections or high levels of certain blood components, are also included to evaluate the test's accuracy in complex cases. Participants provide informed consent, and their samples undergo testing to measure the device's ability to detect antibodies or antigens related to these infections. The main outcomes include evaluating the performance of MagIA H3S in detecting HIV, Hepatitis B and C, and syphilis antibodies, as well as assessing cross-reactivity with other substances or co-infections. The study will monitor these outcomes at baseline using the collected serum or plasma samples, with no direct intervention or treatment involved.

Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)