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

Recruitingn/aAges 18 Years - anyAllMagIA Diagnostics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

2 sites
Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville
Abidjan, Cรดte dโ€™Ivoire
Kenya Medical Research Institute (KEMRI)
Nairobi, Kenya
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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