NCT04289428撤回不适用
Evaluation of Novel Point of Care Hepatitis B Diagnostic Assays
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay
研究概览
简要总结
Evaluation of novel point of care Hepatitis B diagnostic assays.
详细描述
This study aims to evaluate the sensitivity of the following novel assays for evaluation of HBV infection and assessment of treatment eligibility;
- GeneXpert HBV DNA via Fingerstick testing,
- Dried Blood Spot based HBV DNA
- Point of care ALT.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have voluntarily signed the informed consent form.
- •18 years of age or older.
- •HBsAg positive
- •Part A: Not currently on antiviral therapy for HBV and HBV DNA detectable OR Part B: Stable on HBV antiviral therapy for at least 3 months with HBV DNA < 20 IU/ml
排除标准
- •Inability or unwillingness to provide informed consent or abide by the requirements of the study.
结局指标
主要结局
Sensitivity and specificity of the Xpert® HBV DNA fingerstick point of care assay
时间窗: Through study completion, an average of 1 year
To evaluate the sensitivity and specificity of the Xpert® HBV DNA point of care assay from finger-stick whole blood samples compared to plasma samples collected via venipuncture and tested on the Roche COBAS AmpliPrep/COBAS TaqMan HBV (CAP/CTM HBV) V2 assay.
次要结局
- Sensitivity and specificity of the point of care ALT(Through study completion, an average of 1 year)
- Sensitivity and specificity of the Xpert® HBV DNA point of care assay on dried blood spots(Through study completion, an average of 1 year)
研究者
研究点 (1)
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