AQT90 FLEX NTproBNP2 Test Kit Matrix Comparison and Sample Stability Verification Study

Recruiting

• Conditions: Diagnostic Tests

• Registration Number: NCT06905392
• Lead Sponsor: Radiometer Medical ApS

Brief Summary

The purpose of this study is to establish the correlation between sample matrices, and to determine the sample stability for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-04-01
• Status Verified: 2025-05
• Study Start: 2025-05-15
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-28
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 Test Kit.

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• Subject, who has withdrawn consent.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
Correlation	5 month	To establish a correlation between sample matrices
Stability	5 month	To determine sample stability with the NTproBNP2 Test Kit on the AQT90 FLEX analyzer

Trial Locations

Locations (3)

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 Múrcia, Spain

Hospital Clinico Universitario de Santiago Compostela; 🇪🇸 Santiago De Compostela, Spain

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