Evaluation of the Performance of a Highly-sensitive Rapid Diagnostic Test (RDT) Versus Conventional RDT, Compared With PCR as the Gold Standard, in Reactive Case Detection of Malaria Infections in Rakhine State, Myanmar
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,980
- 试验地点
- 1
- 主要终点
- Prevalence of malaria infections identified by the new hsRDT
研究概览
简要总结
A systematic review assessing the role, appropriateness and benefits of the active case detection strategy, both proactive and reactive, in low malaria transmission settings. A common indication is that more studies should be carried out to optimize the ACD strategy to the local context, or to provide evidence for the adoption of improved methods. One possible improved method is the use of more accurate diagnostic tools, such as the hsRDT proposed in this study, with an increased capacity to detect lower levels of parasitemia. It can provide a timely and relevant contribution for their development of national Standard Operating Procedures for a screening tool in the reactive case detection strategy.
详细描述
The study is conducted in the areas under Sakhanmaw Rural Health Center, Ann Township in Southern Rakhine State, Myanmar.
General objective was to evaluate the performance of the new highly-sensitive rapid diagnostic test (RDT) developed by SD Bioline versus conventional RDT, compared with PCR as the gold standard, in reactive case detection of malaria infections in Rakhine State, Myanmar.
Specific objectives
- To evaluate the prevalence of malaria identified by the new hsRDT in comparison with that by cRDT and PCR
- To assess the diagnostic performance characteristics of hsRDT versus cRDT, using PCR as gold standard, in the detection of P.falciparum infections
- To evaluate correlation of detection capability between cRDT and hsRDT
- To identify risk factors associated with malaria infection, including but not limited to, socio-demographic factors and travel history related with malaria index cases
This is a prospective community-based single-center reactive case detection (RCD) study to assess the performance of hsRDT versus cRDT in identifying individuals with malaria infection ("Secondary case") in a population living and/or working in a close physical proximity to an "index case." All cases parasitologically confirmed by conventional RDT will be promptly notified to the study team and interviewed with a standardized case investigation form at their home, possibly within 3 days. All members of the primary case household and those of the nearest 10 households, aged 5 years and above, will be invited to participate in the study. A blood spot will be collected for subsequent PCR analysis. At least 50 index cases are targeted for investigation and reactive case detection and an estimated number of 1,980 persons will be involved in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at least 5 years old
- •Resident of the villages, or temporary visitors, or co-workers or co-travelers of index case
- •Willingness to participate in the study evident by informed consent
排除标准
- •Presence of severe clinical illness including severe malaria
- •Non-resident index cases
- •Refusal to participate in the study
研究组 & 干预措施
Diagnostic performance of hsRDT
Comparing diagnostic power of two diagnostics
干预措施: hsRDT (Diagnostic Test)
结局指标
主要结局
Prevalence of malaria infections identified by the new hsRDT
时间窗: PCR diagnosis of samples will occur after 10 months of data collection.
Outcomes measured by malaria test positivity rate by cRDT, hsRDT and PCR, respectively
次要结局
- Correlation of detection capability between cRDT and hsRDT(PCR results will be analyzed during month 10)
- Diagnostic performance characteristics of hsRDT versus cRDT using PCR as gold standard, in the detection of P.falciparum infections(Outcomes will be analyzed after 10 months of data collection)
- Risk factors associated with malaria infection cases(Outcome will be measured/analyzed in month 10, after PCR results are released)