Evaluation of a Diagnostic Device, CL Detect Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results
研究概览
简要总结
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.
详细描述
Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age and generally healthy
- •Subject able to give written informed consent
- •Subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion:
- •less than 4 months in age
- •primarily ulcerative, ie not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
- •in a location suitable for collecting samples by dental broach, scraping, and aspiration
- •In the opinion of the investigator, the subject is capable of understanding and complying with the protocol
排除标准
- •Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome
结局指标
主要结局
Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results
时间窗: within 1 hour after taking samples
Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results. Note: only data where results for all three methods were available were included in the analysis.
次要结局
未报告次要终点