AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study

July 2, 2025 updated by: Radiometer Medical ApS
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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain
        • Hospiltal Universitari Germans Trias i Pujol
      • Madrid, Spain
        • Clinica Universidad de Navarra
      • Ùbeda, Spain
        • Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient population with expected NT-proBNP concentrations within the measuring range of NTproBNP2 assay.

Description

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  • Subject, who has withdrawn consent.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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Slope, R
Time Frame: 5 month
Slope, R, for NTproBNP2 Test Kit on the AQT90 FLEX analyzer vs. Elecsys proBNP II assay across sites
5 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiometer Medical ApS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2024

Primary Completion (Actual)

June 11, 2025

Study Completion (Actual)

June 11, 2025

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • DC-087457

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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