AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study

NCT06834880 | Completed FDA Device

• 1 other identifier: DC-087455
• Study Type: observational
• Target: 781
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish the overall (age- and sex independent) at least 95th percentile upper reference limit (URL) of the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 95th percentile of normal concentrations with 95% confidence intervals (CI) for overall samples

  The primary endpoint of this study is to establish at least 95th percentile of normal concentrations with 95% confidence intervals (CI) for overall samples for the AQT90 FLEX NTproBNP2 Test Kit by analyzing LiHep plasma samples collected from apparently healthy subjects.

  Baseline

Secondary Outcomes (1)

• 95th percentile for normal concentrations separately for both males and females

  Baseline

Study Arms (1)

Healthy population

ADLM universal sample bank from healthy individuals are used in the study.

Device: No intervention; Observational study

Interventions

No intervention; Observational study DEVICE

Sample bank with Health Questionnaire

Healthy population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A minimum of 351 apparently healthy subjects in total and an approximately equal sex distribution is required for the study (i.e., approximately 50% male and 50% female population). The expected age range is from 18 and up to 90 years.

You may qualify if:

• Subject must have given their valid consent to donate their sample in the sample bank
• Subjects must have been 18 years of age or older at the time of sample collection
• Subject must have answered yes, to being generally healthy, in the health questionnaire
• Subjects must, as a minimum, have completed questions regarding age, gender, race, and ethnicity

You may not qualify if:

• Answered yes to any of the conditions below (Information gathered from a self-reported health questionnaire or results from blood sample tests):
• Current medications for treating cardiovascular diseases at the time of sample collection
• Current antibiotics (Indicates ongoing infections)
• Known to suffer from any of the illnesses below at the time of sample collection:
• Disease(s) of/or affecting the cardiovascular system
• Congestive heart failure
• Hypertension
• Previous history of any heart disease
• Diabetes (Either self-reported in questionnaire or a glycosylated hemoglobin (HbA1C) in the diabetic range (above 6.4%)
• Renal dysfunction or failure (An estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2.) This is to be calculated using information on age, sex and creatinine using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation.
• Cancer or history of cancer

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (1)

Radiometer Turku Oy

Turku, 20750, Finland

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Observation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 19, 2025
• Study Start: January 27, 2025
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

FI (1)