AQT90 FLEX NTproBNP2 Test Kit Matrix Comparison and Sampl... | NCT06905392

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

NCT06905392

Sponsor

Radiometer Medical ApS

Status

Completed

Last Update Posted

Feb 17, 2026Actual

Enrollment

154Actual

Phase

Not provided

Conditions

Diagnostic Tests

Interventions

Not provided

Countries

United States
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2025Actual

Primary Completion Date

Jan 2, 2026Actual

Completion Date

Jan 2, 2026Actual

First Submitted Date

Mar 25, 2025

First Submission Date that Met QC Criteria

Mar 25, 2025

First Posted Date

Apr 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2026

Last Update Posted Date

Feb 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

154Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation	To establish a correlation between sample matrices	5 month
Stability	To determine sample stability with the NTproBNP2 Test Kit on the AQT90 FLEX analyzer	5 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hennepin Healthcare (Research Institute/ Minneapolis Medical Research Foundation)		Minneapolis	Minnesota	55404	United States