MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorGardiens de Vies

About this trial

Performance study to evaluate the clinical performance of the In-Vitro Diagnostic 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 pregnant women attending antenatal care (ANC) services in the Democratic Republic of the Congo. This study aligns with the WHO 2022-2030 strategy for the integrated elimination of mother-to-child transmission of HIV, HBV, HCV, and syphilis.

Eligibility criteria

Qualifiers

Being pregnant, regardless of age or stage of pregnancy (prenatal period);

Having signed an informed consent form at the start of prenatal care (CPN) to participate in the study.

Have chosen to attend prenatal care at the healthcare facility selected for the study;

Plan to give birth at the same healthcare facility where they were included in the study;

Disqualifiers

Women in labor or who refuse to give their consent.

Trial design

Treatments tested in this trial

  • MAGIA H3S

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators

Gardiens de Vies

Lead sponsor

Institut Pasteur

Collaborator

MagIA Diagnostics

Collaborator