Point of Care Tests for Cutaneous Leishmaniasis: Prospective Evaluation of LoopampTM and CL DetectTM Rapid Test for Cutaneous Leishmaniasis Diagnosis in Afghanistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 主要终点
- Diagnostic performance of CL Detect RDT and Loopamp Leishmania Detection Kit
研究概览
简要总结
New point-of-care (POC) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients with access to accurate diagnosis, and enable prompt treatment. Simpler tests could improve treatment access and benefit patients and communities, by reducing the risk of sequelae and the risk of disease transmission. CLeishPOCAFG aims to advance the diagnosis of CL by using more accurate and field-amenable methods.
详细描述
The investigators enrolled 274 CL suspects in the study to determine the diagnostic performance of LoopampTM Leishmania Detection Kit and CL DetectTM Rapid Test for CL diagnosis in Afghanistan. The study was conducted at the National Malaria & Leishmaniasis Control Program (NMLCP) Leishmaniasis Clinic in Kabul, Afghanistan.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs compatible with cutaneous leishmaniasis
- •Age ≥ than two years old.
- •Informed consent obtained and documented.
- •Clinical samples can be obtained.
排除标准
- •Age less than two years old.
- •Failure to obtain and document informed consent.
- •Cutaneous leishmaniasis suspects from whom, for any reason, the required clinical samples needed for the study cannot be obtained.
- •Patients already receiving CL treatment at the time of enrolment.
结局指标
主要结局
Diagnostic performance of CL Detect RDT and Loopamp Leishmania Detection Kit
时间窗: Through study completion, an average of 6 months
Sensitivity and Specificity of the two diagnostic tests
次要结局
未报告次要终点