Verifying Remote Low Volume Blood Tests for Genito-urinary Infections Including Syphilis and Bloodborne Viruses
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparative capillary and venous samples screening testing
研究概览
简要总结
Capillary blood sample results are compared to venous blood results
详细描述
Capillary blood samples can be taken by patients from their own finger without requiring a healthcare professional to take a blood sample. Samples taken this way can be posted from home. This crucially avoids visits to the clinic or hospital to have blood samples taken. It would reduce the burden on healthcare professionals and is often preferred by patients. It is important to demonstrate that the results of an analysis performed on capillary blood samples are equivalent to the analysis of a standard venous sample.
This study aims to collect, in parallel to a standard venous blood sample, a capillary blood sample taken by the participant which is then added to specially designed filter paper (dried plasma spot sample) or other collection devices. Parallel analysis of paired samples will then allow the investigators to assess if results measured in samples taken using the two methods are similar.
The investigators will recruit 40 participants for each collection device to this study. It is important to obtain a range of positive and negative results from the study participants, and from stored samples and quality control material.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide informed consent.
- •Already having a venous blood sample for clinical care
排除标准
- •Failure to consent
结局指标
主要结局
Comparative capillary and venous samples screening testing
时间窗: 1 year
To have sufficient parallel samples (capillary and venous) collected to demonstrate equivalence of the results of HIV, HBV, HCV and syphilis testing using the Roche Cobas e601 platform
次要结局
- Comparative capillary and venous samples confirmatory testing(1 year)
