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RecruitingMultiplex Testing of HIV, HBV, HCV and SyphilisHIVHBV

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

Eligible age

18+ yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

Yes

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About this study

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.

Sponsor: MagIA Diagnostics

You may qualify if…

  • 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:

You may not qualify if…

  • Samples from patients below 18 years of age

Source: ClinicalTrials.gov · NCT07170748 · last updated 2026-02-02

Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV · TrialPath