MagIA H3S multiplex rapid blood test for HIV, hepatitis B and C, and syphilis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.