Molecular Characteristics and Prevalence of Viral Hepatitis E in Human Tissue and Cell Donors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Prevalence of Hepatitis E in the study groups
研究概览
简要总结
In this study, the researchers want to focus on the prevalence of anti-HEV antibodies by a new generation test, direct detection of HEV RNA, and its genotypic analysis in a group of human tissue and cell donors.
详细描述
At the Department of Laboratory Medicine of the Faculty of Medicine of the Faculty of Medicine of the National University of Health Sciences, human tissue and cells from donors will be examined for the assessment of health eligibility and donor selection according to Decree No. 422/2008 Coll. According to the current legislation, the determination of IgG and IgM antibodies against HEV or the HEV RNA method is not part of the standard examination of human tissue and cell donors for the assessment of their health eligibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking will be used in the study.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- patients indicated for organ or cell donation
排除标准
- 未提供
结局指标
主要结局
Prevalence of Hepatitis E in the study groups
时间窗: 2 years
The prevalence of Hepatitis E will be observed in both study groups, measured as the number of positive samples from the total number of samples.
次要结局
- Presence of Hepatitis E (HEV) RNA in the study groups(2 years)