Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/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

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.

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