Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Clinical Performance of the MagIA IBC test in determining the serological status of HIV infection, HCV infection (current infection only) and HBV infection
研究概览
简要总结
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV antibodies (HIV-Ab), anti-HCV antibodies (HCV-Ab), and HBs antigens (HBs-Ag) in serum, plasma, venous blood and capillary blood. If not prescribed for the patient care, blood drawings, and finger pricks will be performed on the patient for the purpose of the clinical study.
The Study includes a Technical Adjustment Phase (to identify optimized acquisition parameters and to define the decision threshold for the diagnostic) followed by a Validation Phase (to validate the concordance between the matrices and to evaluate the Specificity and the Sensibility of the diagnostics).
Validation Phase is between Sept. 2024 and still ongoing.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •A Male or Female aged of at least 18 years
- •A person responding to one of the following conditions:
- •known having HIV infection
- •or known having HBV infection
- •or known or suspected having HCV infection with anti-HCV RDT positive. IC
- •A person having given consent to participate the study, IC
- •A person covered by a medical insurance or being enrolled during an outdoor testing campaign.
排除标准
- •A person for whom blood sampling would represent a risk, EC
- •A person protected by law (minor, under guardianship or curatorship, childbearing, or breastfeeding female, hospitalized without consent, under administrative or judicial supervision)
研究组 & 干预措施
Single arm
This study is single arm.
干预措施: MagIA IBC test in capillary blood (Diagnostic Test)
Single arm
This study is single arm.
干预措施: MagIA IBC test in other blood matrices (Diagnostic Test)
结局指标
主要结局
Clinical Performance of the MagIA IBC test in determining the serological status of HIV infection, HCV infection (current infection only) and HBV infection
时间窗: baseline
For each of the 3 diagnostics, the corresponding Endpoints are the Sensitivity (Se) and Specificity (Sp) of MagIA IBC.
次要结局
- Concordance of the results delivered by MagIA IBC for HIV and HBV, on each of the selected matrices (i.e. serum, plasma, venous and capillary blood).(baseline)
- Adverse events of MagIA IBC test(1 day)