Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of CL detect RDT
研究概览
简要总结
Cutaneous Leishmaniasis (CL) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries. Various CL species are present in different parts of the world, and these different species vary in severity, prognosis and therapeutic approaches.
At ITM, diagnosis of CL in suspected patients is done using a skin biopsy, analyzed by diagnostic PCR, and species typing PCR. This method is invasive, and diagnosis is often delayed for days to weeks.
The new antigen-based CL Detect Rapid Test uses dental broach sampling and has results within 30 minutes. Dental broach samples left over from the Cl Detect Rapid test may still be used for PCR including species typing.
How well the CL Detect Rapid Test performs in the varied population of a travel clinic and whether it is possible to use dental broach sampling for further PCR tests in this population needs to be evaluated The aim of this study is to study the performance of the CL Detect Rapid Test and whether dental broach sampling can replace skin biopsy for CL at ITM.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Skin biopsy for leishmania test requested by treating ITM clinician OR
- •externally requested skin biopsy for Leishmania tested at ITM with an ITM consultation <7 days of the biopsy sample
- •willing and able to provide consent/assent
- •not on CL treatment
排除标准
- 未提供
结局指标
主要结局
Diagnostic accuracy of CL detect RDT
时间窗: 2019-2010
Against combined reference of microscopy and PCR using skin punch biopsy
次要结局
- Proportion of PCR positives on dental broach sample(2019-2020)
- Proportion of successful species typing on dental broach sample(2019-2020)