Diagnoses Disease, Plasmodium Falciparum Malaria, Pregnancy Malaria
Conditions
Keywords
malaria, pregnancy, diagnosis, rapid diagnostic test
Brief summary
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
Interventions
DIAGNOSTIC_TESTHS-RDT
A single finger-prick blood sample will be collected and used to test participants with the HS-RDT. The results of the results of the test will not be used for treatment purposes nor used to inform patient care.
Sponsors
Foundation for Innovative New Diagnostics, Switzerland
Burnet Institute
Papua New Guinea Institute of Medical Research
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Inclusion criteria
* All women must meet all the following inclusion criteria in order to be eligible to participate in the study: * Pregnant women attending first antenatal care visit at selected health facilities * Resident in the study area for at least 1 year prior to enrolment * Age ≥ 16 * Willing to freely participate with signed informed consent (or, if illiterate, provide a thumbprint in the presence of an independent witness) * Willing to provide finger-prick blood sample
Exclusion criteria
* Women meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity, specificity, negative predictive value and positive predictive value | 1 year | 1.1 Estimates of sensitivity, specificity, negative predictive value, positive predictive value, and diagnostic odds ratio of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and LAMP in peripheral blood with qPCR as reference test. |
Countries
Papua New Guinea
Outcome results
None listed