Prospective Evaluation of a Rapid Diagnostic Test to Screen for Gambiense Human African Trypanosomiasis and Diagnose Plasmodium Falciparum Malaria
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening
研究概览
简要总结
A prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African trypanosomiasis (HAT) and diagnose P. falciparum malaria (the "HAT/malaria combo") has recently been developed. The performance of this prototype has been evaluated in a retrospective study that showed that its diagnostic performance for HAT and malaria was equivalent to the performance of the SD BIOLINE HAT 2.0 and the SD BIOLINE Malaria Ag P.f tests, respectively.
The purpose of this study is to prospectively evaluate the performance of the test in settings where P. falciparum malaria is endemic, and which are either endemic or non-endemic for HAT. This will enable the assessment of the suitability of the HAT/malaria combo RDT as a diagnostic test for malaria, and a screening test for HAT in pre-elimination and post-elimination contexts, respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than or equal to 6 years
- •Provision of signed informed consent. For children (under the age of 18) provision of signed informed consent by a parent or legal guardian and an age appropriate assent.
排除标准
- •Severe anaemia preventing collection of a sample of venous blood
- •Severe medical condition preventing informed consent and trial participation (e.g. coma, cognitive impairment, etc.)
- •For HAT true negatives only: history of previous HAT infection
结局指标
主要结局
sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening
时间窗: Enrolment
specificity of the HAT/malaria combo test for P. falciparum malaria in passive screening
时间窗: Enrolment
specificity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening
时间窗: Enrolment
specificity of the HAT/malaria combo test for gambiense HAT in passive screening
时间窗: Enrolment
specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening
时间窗: Enrolment
sensitivity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening
时间窗: Enrolment
次要结局
- specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic(Enrolment)
- specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic(Enrolment)
- specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic(Enrolment)
- specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic(Enrolment)