Diagnoses Disease Clinical Trial
Official title:
Clinical Performance of the HRP2 HS-RDT for Malaria Diagnosis in Pregnant Women in Papua New Guinea
Malaria during pregnancy remains an important public health issue in endemic countries. Most
cases of malaria in pregnant women are asymptomatic, and can contribute to adverse outcomes,
such as maternal and neonatal anaemia as well as low birth weight. Infections that do not
cause symptoms (sub-clinical infections) - particularly in low transmission settings -remain
difficult to diagnose during pregnancy but can contribute to adverse outcomes e.g. growth
restriction, premature birth, miscarriage and stillbirth.
The Bill & Melinda Gates Foundation (BMGF) has supported the development of an HRP2-based
high sensitivity rapid diagnostic tests (HS-RDT) that has analytical sensitivity ten times
better than current RDTs and a sensitivity near 80% when compared to the 'gold standard' of
quantitative polymerase chain reaction (qPCR). In this regard, the new HS-RDT may be a
promising diagnostic and screening test for subclinical malaria during pregnancy.
The overall aim is to compare the performance of novel high sensitivity rapid detection tests
with conventional rapid diagnostic tests for Plasmodium falciparum malaria infection in
pregnant women in Papua New Guinea
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