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

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.

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.

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.

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.

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.

Performance evaluation of MagiA TREATB test in detection of HbeAg, ALT and HbsAg quantification women who gave birth. 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.

System usability scale will be used to assess the usability of use of the MagiA H3S test from healthcare personnel who have used the diagnostic tests. The score's scale ranges from 1 to 5. 1 means strongly disagree and 5 strongly agree.

Prevalence of HIV, HBV, HCV and Syphilis using laboratory tests results of pregnant women in DRC.

The number of pregant women who accepted antenatal screening (rapid diagnostic tests and MagiA H3S) to detect HIV, HBV, HCV, and syphilis compared to total number of pregnant women attending antenatal services.

Number of positive test results for HIV, HBV, HCV and Syphilis communicated to pregnant women who tested positive during antenatal consultations.

Treatment adherence of study participants receiving treatment will be assessed at each follow-up visit using the 8-item Morisky Medication Adherence Scale. The Morisky adherence scale yields a score ranging from 0 to 8, with higher scores indicating better adherence to treatment.

Rate of newborns of pregnant women infected with HBV who received the hepatitis B vaccine

For each of the four infections: ratio between number of newborns born to positive pregnant women and number of positive newborns is calculated

Medical-economic evaluation of the MAGIA H3S diagnostic test by analyzing the costs associated with its implementation and its cost-effectiveness, compared to the absence of screening in routine antenatal care (status quo), and with the implementation of rapid HIV, HBV, HCV, and syphilis tests.

• Total economic cost of introducing the MAGIA TREAT B test to identify pregnant women eligible for antiviral prophylaxis against Hepatitis B.
• Cost-effectiveness assessment of the MAGIA TREAT B test, compared to the status quo and to viral load quantification or the HbeAg test.

• Total economic cost of introducing the MAGIA TREATB test to identify women infected with hepatitis B virus who are eligible for long-term treatment for their own health
• Cost-effectiveness assessment of the MAGIA TREAT B test, compared to the status quo, as well as to the use of the APRI score, or the measurement of viral load and/or ALT levels.

Preference estimated as odd ratio from a discrete choice experiment.

Health facility service availability and readiness will be presented as percentage ranging from 0% to 100% for included indicators using the WHO's Service Availability and Readiness Assessment (SARA) tool. The study will describe the percentage of service availability and readiness for each health facility.