NCT06834880

AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study

AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 781 (actual)
• Sponsor: Radiometer Medical ApS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to establish the overall (age- and sex independent) at least 95th percentile upper reference limit (URL) of the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.

Detailed description

The NTproBNP2 Test is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-B-type natriuretic peptide {NT-proBNP) in EDTA or lithium heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care/ near-patient testing and laboratory settings. It is intended for use as an aid in the diagnosis of heart failure. The test is also intended for use as an aid in the risk stratification of patients with acute coronary syndrome and heart failure. The NTproBNP2 CAL Cartridge is an in vitro diagnostic reagent intended for the calibration adjustment of the NTproBNP2 Test on the AQT90 FLEX analyzer by establishing points of reference to estimate NT-proBNP values. The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point of care/ near-patient testing and laboratory settings.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	No intervention; Observational study	Sample bank with Health Questionnaire

Timeline

• Start date: 2025-01-27
• Primary completion: 2025-02-05
• Completion: 2025-02-05
• First posted: 2025-02-19
• Last updated: 2025-08-06

Locations

1 site across 1 country: Finland

Regulatory

• FDA-regulated device study