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

MAGIa In-vitro- Diagnostics Medical Device Dedicated to Combined Screening of HIV, HBV, HCV and Syphilis and HBV Reflective Panels aMong Congolese pregnAnt woMen Attending to Ante Natal Care Consultations

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.

Inclusion Criteria:

• 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.

Note: for pregnant minors, the consent of a parent or legal guardian is required;

• 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;
• Plan to attend postnatal care (PNC) and preschool consultations (PSC) at the same healthcare facility where they were included in the study.
• Plan to give birth at the same health facility where they were enrolled;
• Plan to attend postnatal consultations (PNC) and preschool consultations (PSC) at the same facility

Exclusion Criteria:

• Women in labor or who refuse to give their consent.