NCT07170748 Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
| NCT ID | NCT07170748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MagIA Diagnostics |
| Condition | Multiplex Testing of HIV, HBV, HCV and Syphilis |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,950 participants |
| Start Date | 2025-07-29 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,950 participants in total. It began in 2025-07-29 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07170748 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiplex Testing of HIV, HBV, HCV and Syphilis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07170748 currently recruiting?
Yes, NCT07170748 is actively recruiting participants. Visit ClinicalTrials.gov or contact MagIA Diagnostics to inquire about joining.
Where is the NCT07170748 trial being conducted?
This trial is being conducted at Abidjan, Côte d’Ivoire, Nairobi, Kenya.
Who is sponsoring the NCT07170748 clinical trial?
NCT07170748 is sponsored by MagIA Diagnostics. The trial plans to enroll 2,950 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.