MagIA H3S multiplex rapid blood test for HIV, hepatitis B and C, and syphilis
Clinical Performance Evaluation of MagIA In-vitro Diagnostic Medical Device for Multiplex Screening of Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C and Syphilis in Sub-Saharan Africa
This project will test a single blood-based point-of-care test that checks for HIV, hepatitis B and C, and syphilis using serum or plasma samples from people at sites in Ivory Coast and Kenya.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2950 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MagIA Diagnostics Industry-sponsored |
| Locations | 2 sites (Abidjan and 1 other locations) |
| Trial ID | NCT07170748 on ClinicalTrials.gov |
What this trial studies
This observational performance study collects serum and plasma samples prospectively and retrospectively at sites in Abidjan, Côte d'Ivoire and Nairobi, Kenya to run the MagIA H3S multiplex point-of-care assay. Samples include known positives for HIV-1/2, HBsAg, HCV antibodies, and syphilis (TPHA/VDRL), as well as negative controls such as blood donors, clinic patients, and vulnerable populations. Results from the MagIA H3S will be compared to established laboratory reference tests to measure sensitivity, specificity, and potential cross-reactivity, including testing samples with potential interfering infections or pregnancy. The sponsor MagIA Diagnostics works with Institut Pasteur, KEMRI, and local partners to perform testing and collect data.
Who should consider this trial
Good fit: Ideal candidates are people who can provide a serum or plasma sample and include known positives for HIV, HBV, HCV, or syphilis as well as negative controls such as blood donors, clinic attendees, and samples from pregnant people or those with other infections for interference testing.
Not a fit: People who cannot provide a serum or plasma sample, who do not consent, or who are located outside the participating sites in Ivory Coast and Kenya are unlikely to participate or benefit.
Why it matters
Potential benefit: If successful, the MagIA H3S could enable faster, same-visit screening for multiple infections from a single blood sample, helping people get diagnosed and linked to care sooner.
How similar studies have performed: Other point-of-care multiplex tests for HIV, hepatitis and syphilis have shown promising results in some settings, but performance varies by device and local conditions and this device requires independent clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 following conditions: * Being a pregnant woman * Infected with at least one of the following viruses or bacteria: hepatitis A virus (HAV), hepatitis E virus (HEV), tuberculosis (TB), gonorrhoea, chlamydia, influenza virus, Covid-19 * Presenting any of the following criteria: * High IgG levels * High rheumatoid factor (\>15 IU/mL) * High cholesterol levels (\>0.24 md/dL) * High bilirubin levels (\>0.25 mg/mL) * High triglyceride levels (\>500 mg/dL) * Diagnosis of cancer Exclusion Criteria: * Samples from patients below 18 years of age
Where this trial is running
Abidjan and 1 other locations
- Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville — Abidjan, Côte d’Ivoire (Recruiting)
- Kenya Medical Research Institute (KEMRI) — Nairobi, Kenya (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.