ApoDiag: A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,474
- 试验地点
- 1
- 主要终点
- APOE Genotype
研究概览
简要总结
Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro-diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests detect several gene mutations related to the above-mentioned pathologies. The development of IVD tools requires the evaluation of analytical parameters including biomarker stability.
The present specific study therefore aims to collect whole blood samples in PAXgene DNA tubes to complete the analytical validation of IVD tools and the evaluation of the stability of the DNA in PAXgene DNA tubes and the reagents in the IVD tools.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Donors who sign the informed consent forms for sample collection and for genotyping.
- •Adults, both genders, aged 18-85 years.
- •Not under any administrative or legal supervision
排除标准
- •Anyone who did not sign the Informed Consent form.
- •Subjects aged below 18 years and older than 85 years are excluded.
- •Pregnant, parturient and nursing women are excluded
结局指标
主要结局
APOE Genotype
时间窗: Baseline
Blood samples will be collected to establish the feasibility of detecting several gene mutations associated with the risk of Alzheimer's disease/ Cardiovascular disorder and validation of analytical parameters
次要结局
- Specimen stability(Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months)