WHO has granted the first prequalification listing of a bundle of three diagnostics tests to be used for pregnant women for the qualitative detection of HIV, Hepatitis B Surface Antigen, and Treponema pallidum Syphilis antibodies in human capillary whole blood. The Determine™ Antenatal Care Panel is composed of 3 strips:
- Determine™ Syphilis TP – Detects IgG/IgM antibodies to Treponema pallidum
- Determine™ HIV Early Detect – Detects HIV-1/2 antibodies and free HIV-1 p24 antigen
- Determine™ HBsAg 2 – Detects Hepatitis B surface antigen
The product is designed to contribute to antenatal care and to empowering healthcare professionals to deliver faster, more integrated care, especially in resource-limited settings.
Pregnancy-related preventable morbidity and mortality remains unacceptably high. Antenatal care (ANC) provides a platform for important health-care functions, including health promotion, screening and diagnosis, and disease prevention. The primary aim of ANC is to promote and protect the health of women and their unborn babies during pregnancy so as to achieve at the end of a pregnancy both a healthy mother and a healthy baby. In this context WHO's Department of Global HIV, Hepatitis and STI Programmes is developing guidance on multiplex testing which will provide recommendations on the use multiplex tests. More applications for prequalification assessment of multiples tests are expected in the future.
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