AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study

NCT ID: NCT06693050

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-09

Study Completion Date

2025-06-11

Brief Summary

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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

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Conditions

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Diagnostic Test

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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* Subject, who has withdrawn consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radiometer Medical ApS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospiltal Universitari Germans Trias i Pujol

Badalona, , Spain

Site Status

Clinica Universidad de Navarra

Madrid, , Spain

Site Status

Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz

Ùbeda, , Spain

Site Status

Countries

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Spain

Other Identifiers

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DC-087457

Identifier Type: -

Identifier Source: org_study_id

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