NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Clinical Evaluation Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- AQT90 FLEX NTproBNP2 Test Kit - Clinical Evaluation - China
研究概览
简要总结
To validate the NTproBNP2 Test Kit by using the test results of the predicate device as a reference. It will be demonstrated that the investigational product (NTproBNP2 Test Kit) and the predicate are equivalent. Subsequently, it will be demonstrated that the investigational product can be used in clinical testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Samples that meet all the following criteria will be eligible for enrollment:
- •Samples from subjects with current or previous signs and/or symptoms of heart failure, or diagnosed heart failure.
- •Sample-related information is available, including a unique and traceable number, sample type, age, gender, date of sample collection, and clinical diagnosis, etc..
- •The sample volume is adequate, no less than 2 mL of whole blood.
- •The sample collection shall meet the informed consent waiver requirements of the ethics committee.
排除标准
- •Samples that meet any of the following criteria will be excluded:
- •Duplicate collection of samples from the same subject.
- •Samples that do not meet the collection, handling, and storage requirements outlined in the product's instructions for use.
- •Samples that are suspected of being poor quality, i.e. samples suspected of containing clots, visible hemolysis or lipids, or samples suspected of being contaminated with possible interfering substances.
结局指标
主要结局
AQT90 FLEX NTproBNP2 Test Kit - Clinical Evaluation - China
时间窗: 12 months
Clinical evaluation indicator: The correlation coefficient between the investigational reagent and the predicate. Evaluation criteria: The correlation coefficient between the investigational reagent and the predicate shall not be less than 0.95. The slope should be within the range of \[0.9, 1.1\]. If this requirement is not met, it is recommended to increase the sample size and provide a detailed rationale.
次要结局
未报告次要终点