NCT07170748招募中不适用
Clinical Performance Evaluation of MagIA In-vitro Diagnostic Medical Device for Multiplex Screening of Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C and Syphilis in Sub-Saharan Africa
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,950
- 试验地点
- 2
- 主要终点
- Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab
研究概览
简要总结
Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from serum, plasma samples collected prospectively or retrospectively in Ivory Coast and Kenya.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Provide informed consent for participation in this study.
- •Patient sample must meet at least one of the criteria below:
- •1. Positive samples (serum or plasma) from individuals who meet at least one of the following conditions:
- •HIV-1 Ab positive
- •HIV-2 Ab positive
- •HCV-Ab positive
- •HBsAg positive
- •Positive for at least TPHA, with those positive for both TPHA and VDRL ideally included
- •Negative samples (serum or plasma) from individuals who meet at least one of the following conditions:
- •Blood donors
- •Hospitalized patients or individuals coming to the clinic
- •Vulnerable populations (such as: drug users, prison population, ...)
- •Negative samples (serum or plasma) containing potential interfering substances from individuals who meet at least one of the following conditions:
- •Being a pregnant woman
- •Infected with at least one of the following viruses or bacteria: hepatitis A virus (HAV), hepatitis E virus (HEV), tuberculosis (TB), gonorrhoea, chlamydia, influenza virus, Covid-19
- •Presenting any of the following criteria:
- •High IgG levels
- •High rheumatoid factor (>15 IU/mL)
- •High cholesterol levels (>0.24 md/dL)
- •High bilirubin levels (>0.25 mg/mL)
- •High triglyceride levels (>500 mg/dL)
- •Diagnosis of cancer
排除标准
- •Samples from patients below 18 years of age
结局指标
主要结局
Performance evaluation of MagIA H3S in detection of HIV-Ab, HBAg, HCV-Ab and TP-Ab
时间窗: Baseline
Diagnostic sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) of the MagIA H3S device for detecting each of the four markers: HIV-Ab, HCV-Ab, HBsAg, and TP-Ab, compared to reference standard testing.
次要结局
- Evaluation of cross-reactivity with any potentially interfering substances or interferences with any co-infection or comorbidity(Baseline)
- Evaluation of performance of MagIA H3S in determining on-going HCV infection(Baseline)
研究者
研究点 (2)
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