Evaluation of a Highly Sensitive Rapid Diagnostic Test for Detecting Falciparum Malaria Infection in Pregnancy in Burkina Faso
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Specificity of HS_RDT
研究概览
简要总结
The goal of this observational study is to learn about the diagnostic performance of the highly sensitive rapid diagnostic test (HS-RDT) compared to an ultrasensitive qPCR for detection of falciparum malaria in pregnant women attending antenal care (ANC) in Burkina Faso. The main question it aims to answer is:
• What are the sensitivity and specificity of the HS-RDT compared to ultrasensitive quantitative polymerase chain reaction (qPCR) considered as gold standard for dection of falciparum malaria in pregnant women attending ANC in Burkina Faso ? Participants will be included during their ANC visits and screened for malaria using the HS_RDT, the conventional RDT (Co_RDT), microscopy, and qPCR.
详细描述
A cross-sectional study including 288 pregnant women was conducted at the Centre médical urbain (CMU) of Lafiabougou located in the periurban area of Bobo-Dioulasso the second largest city of Burkina Faso. Pregnant women attending their ANC visits at the CMU of Lafiabougou were recruited and enrolled into the study if eligible criteria were fulfilled.
At enrolment, an individual structured questionnaire was administered to the selected pregnant women and their sociodemographic data (age, educational level, and profession) and history of illness was collected. In addition, obstetric history (parity, gestational age, number of ANC visits, uptake of IPTp-SP) and clinical information (body temperature, weight, height, and arm circumference) were recorded. Thereafter, a venous blood sample (5 mL) was collected to screen for malaria infection (based on HS-RDT, Co_RDT, and thick and thin blood smears), dried blood spots (DBS) (for molecular studies), and haemoglobin concentration measurement. The remaining blood sample was stored for future studies.
After enrolment, only pregnant women eligible for their first IPTp-SP dose uptake was followed up for 30 days to assess the impact of IPTp-SP on both falciparum parasitaemia and falciparum resistant strains. At the end of follow up, a venous blood sample (5 mL) was collected for thick and thin blood smears, DBS, and haemoglobin concentration measurement. The remaining blood sample was stored for future studies.
All biological samples was collected and stored at ambient temperature before being transported to the Laboratory of Parasitology of Centre MURAZ and processed.
The index tests included HS_RDT (NxTek Eliminate Malaria Pf, product code 05FK140, batch No. 05LDG008B, Alere/Abbott, Republic of Korea), Co_RDT (AdvDxTM Malaria Pf, product code 004ADFEF025KI-2, batch No. ADF77/0222, Advy Chemical, India), and light microscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Living in Bobo-Dioulasso for at least 6 months before the beginning of the study ;
- •Provision of informed consent.
排除标准
- •Past history of malaria or antimalarial drugs within the last 3 months ;
- •Having tested positive for malaria by microscopy or RDT in any previous ANC visit ;
- •Symptoms and signs of severe malaria as defined by WHO.
结局指标
主要结局
Specificity of HS_RDT
时间窗: At baseline
It is defined as proportion of negatives that are correctly identified when compared with the gold standard (qPCR).
Sensitivity of HS_RDT
时间窗: At baseline
It is defined as the proportion of positives that are correctly identified when compared with the gold standard (qPCR).
次要结局
- Impact of intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp- SP) on falciparum parasitaemia(30 days after uptake of IPTp-SP)
- Positive predictive value(At baseline)
- The prevalence of Pfhrp2 and Pfhrp3 genes deletions among the study participants(At baseline)
- Negative predictive value(At baseline)
研究者
Mamoudou Cissé
Assistant Professor of Parasitology and Mycology
Centre MURAZ/Institut National de Santé Publique