Clinical Performance of the Histidine Rich Protein 2 (HRP2) Highly Sensitive Rapid Diagnostic Test (HS-RDT) for Malaria Diagnosis in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 880
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
This is a cross-sectional and multicentre clinical trial to study the performance of the Histidine Rich Protein 2 (HRP2) highly sensitive rapid diagnostic test (HS-RDT) for the detection of malaria during pregnancy in low transmission settings from Colombia and Indonesia. The new HS-RDT will be compared with conventional good quality RDTs, microscopy, and NAATs [loop-mediated isothermal amplification (LAMP), nested PCR (nPCR)], in peripheral blood samples with quantitative reverse transcription PCR (qRT-PCR) as reference standard.
详细描述
The activities proposed will be performed in the context of health centres receiving pregnant women for antenatal care visit. Finger-prick blood (300 µL) will be collected and used to test for malaria with the HS-RDT, as well as with conventional good quality RDTs, microscopy and local NAATs (LAMP and nPCR). Dried blood spots will also be collected for qRT-PCR testing. Patient information (demographics, obstetric history, malaria prevention measures, etc.) as well as laboratory results will be recorded and entered into a dedicated database.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with confirmed pregnancy and registered to the antenatal care programme in the local health centre
- •Resident for at least 1 year in the study site
- •Accepting to participate with willingness to give informed consent (pregnant adolescents younger than 18 y/o (age < 18) will be considered only if they are accompanied by parent or carer if it is requested by local Institutional Review Boards)
- •Willingness to provide finger-prick blood sample at enrolment
排除标准
- •Past history of malaria and/or antimalarial drugs in the last three months
- •Positive for malaria by microscopy and conventional RDT testing in any previous study screening visit
- •Presence of severe malaria as defined by WHO guidelines at the moment of recruitment
- •Presence of symptoms and signs of other severe disease and central nervous system infections, as defined by WHO guidelines.
结局指标
主要结局
Diagnostic accuracy
时间窗: 1 year
Sensitivity, specificity, negative predictive value, positive predictive value, diagnostic odds ratio (DOR) and the area under the receiver operating characteristic curve (AUROC) of HRP2 HS-RDT for the detection of P. falciparum during pregnancy, compared with conventional good quality RDTs, microscopy and NAATs (LAMP, nPCR,), in peripheral blood with qRT-PCR as reference standard.
次要结局
未报告次要终点