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.
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;
Women in labor or who refuse to give their consent.
Pregnant women attending antenatal care clinics among the 20 health facilities included for this study in DRCongo.
Cohort
Prospective
MAGIA H3S
Diagnostic testMagiA H3S : Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis
Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab
Compare the sensitivity and specificity of the MAGIA H3S test with laboratory reference tests (ELISA/EIA for HIV, HBV and HCV, and syphilis) for detecting the following four markers in Congolese pregnant women: anti-HIV antibodies, anti-HCV antibodies, HBsAg and treponemal antibodies for syphilis.
Positive predictive value (PPV) and negative predictive value (NPV) of MagiA H3S device
NPV and PPV calculated for each of the four diseases, using the laboratory tests as the reference for the entire population and according to different geographical area and socio-demographic context.
Sensitivity and specificity of MagiA H3S device to dignose HIV, HBV, HCV and syphilis.
For each of the four diagnoses, the Sensitivity and specificity of the MAGIA H3S will calculated and compared to the sensitivity and specificity of RDTs test, using fourth generation ELISA as the reference.
Stratum-specific sensitivity and specificity of the H3S test.
For each of the four diagnoses, the sensitivity and specificity of the MagIA H3S device will be calculated by stratifying them according to known infection and/or treatment history.
SE and SP, PPV and NPV of the MagIA TREATB test among pregnants women.
Performance evaluation of MagiA TREATB test in detection of HbeAg, ALT and HbsAg quantification among pregnant women. The MagiA TREAT-B test that detect the Hbe-Ag, the ALT level and quantifies HbsAg will be compared to the laboratory tests as the reference.
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