AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study

Completed

• Conditions: Diagnostic Test

• Registration Number: NCT06693050
• Lead Sponsor: Radiometer Medical ApS

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-18
• Study Start: 2024-12-09
• Primary Completion: 2025-06-11
• Study Completion: 2025-06-11
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• 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.

Exclusion Criteria

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• Subject, who has withdrawn consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Slope, R	5 month	Slope, R, for NTproBNP2 Test Kit on the AQT90 FLEX analyzer vs. Elecsys proBNP II assay across sites

Trial Locations

Locations (3)

Hospiltal Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Clinica Universidad de Navarra; 🇪🇸 Madrid, Spain

Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz; 🇪🇸 Ùbeda, Spain