Clinical Sensitivity and Specificity Study of AQT90 FLEX BNP and NT-proBNP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 569
- 试验地点
- 1
- 主要终点
- Determination of the clinical sensitivity and specificity of the AQT90 FLEX BNP and NT-proBNP assays at the clinical cut-off in heart failure patients
研究概览
简要总结
The AQT90 FLEX B-type Natriuretic Peptide (BNP) and N-terminal pro B-type natriuretic peptide (NT-proBNP) Tests are in vitro diagnostic assays intended as an aid in the diagnosis and assessment of the severity of heart failure in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX BNP and NT-proBNP assays for both whole blood and plasma in the intended use population.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 21 years of age or older
- •Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study
- •Subject has diagnosis of heart failure
排除标准
- •Subject has Acute Coronary Syndrome (ACS)
- •Subject has been diagnosed and/or treated for malignancy within past 6 months
- •Subject has had cardiac surgery within the past 4 weeks
- •Subject claim of pregnancy
- •Subject's prior participation in this study
结局指标
主要结局
Determination of the clinical sensitivity and specificity of the AQT90 FLEX BNP and NT-proBNP assays at the clinical cut-off in heart failure patients
时间窗: Single blood draw upon study entry
Clinical sensitivity and specificity with 95 % confidence intervals of the AQT90 FLEX BNP and NT-proBNP assays will be determined at the clinical cut-off in heart failure patients divided by age, gender and New York Heart Association (NYHA) functional classification.
次要结局
未报告次要终点