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临床试验/NCT06693050
NCT06693050已完成不适用

AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study

Radiometer Medical ApS3 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2024年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
153
试验地点
3
主要终点
Slope, R

研究概览

简要总结

The purpose of this study is to verify performance claims for method comparison for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer in whole blood (WB) and plasma (PL).

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

入选标准

  • Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
  • Subjects must be 18 years of age or older.
  • Subjects with expected NT-proBNP concentrations within the measuring range of NTproBNP2 assay.

排除标准

  • Subjects known to be pregnant or breast-feeding.
  • Subjects previously enrolled in the study.
  • Subject, who has withdrawn consent.

结局指标

主要结局

Slope, R

时间窗: 5 month

Slope, R, for NTproBNP2 Test Kit on the AQT90 FLEX analyzer vs. Elecsys proBNP II assay across sites

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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