Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Recruiting · NCT07170748 · Observational (researchers observe without assigning treatment) · Lead sponsor: MagIA Diagnostics
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Provide informed consent for participation in this study.
- Patient sample must meet at least one of the criteria below:
- \. 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 is running
2 locations listed.
- Centre de Diagnostic et de Recherche sur le SIDA et les autres Maladies Infectieuses - CHU Treichville - Abidjan, Côte d’Ivoire
- Kenya Medical Research Institute (KEMRI) - Nairobi, Kenya