Preliminary Validation of the Demonstrator of an In Vitro Diagnostic Device for Hepatitis B Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- feasibility of correlation
研究概览
简要总结
The principal objective of the study is to perform a first step of technical adjustment and preliminary validation of a diagnostic test for hepatitis B (HBsAntigen, anti-HBs Antibody and anti-HBc Antibody) on capillary blood with the device under study in non-immunized subjects against hepatitis B, in subjects with hepatitis B, in subjects with old or cured hepatitis B and in hepatitis B vaccine recipients, compared with the values obtained with the reference technique of medical biology laboratory on serum. The analysis will be performed on the entire cohort.
详细描述
The diagnosis of hepatitis B in precarious populations is often difficult. The use of a in vitro diagnosis-medical device in point of care could alleviate this difficulty. It would identify whether or not the subjects are infected with the virus, whether they are immunized or not. Then, depending on the results, the subjects could be directly vaccinated or referred to a laboratory of medical biology for confirmation / invalidation of the diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Group 1: HBsAg negative, Anti HBc negative, Anti HBs negative, during a laboratory assay on serum
- •Group 2: HBsAg negative, Anti HBc negative, Anti HBs positive, during a laboratory assay on serum
- •Group 3: HBsAg negative, Anti HBc positive, Ab anti HBs positive or negative, during a laboratory assay on serum
- •Group 4: HBsAg positive, Anti HBc positive, Anti HBs negative, during a laboratory assay on serum
- •all: affiliated to social security or beneficiary of such a scheme
排除标准
- •Infection by a confounding factor: HIV, HCV and / or HDV
- •Protected person: Pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
- •Exclusion period for other research studies involving the human person
- •Annual threshold of allowances for participation in research involving the affected human person.
结局指标
主要结局
feasibility of correlation
时间窗: Day 0
To evaluate the feasibility estimated by correlation of the measurements (HBsAg, anti-HBs Ab, HBc-Ab) between the IVD-MD in point of care on capillary blood study and the laboratory results obtained on serum
次要结局
- reproductibility of the measurement HBsAg, anti-HBs Ab, HBc-Ab(day 0)
- correlation according to status(day 0)
- repeatability of the measurement HBsAg, anti-HBs Ab, HBc-Ab(day 0)