AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study

Completed

• Conditions: Heart Failure

• Registration Number: NCT06834880
• Lead Sponsor: Radiometer Medical ApS

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.

Detailed Description

The NTproBNP2 Test is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-B-type natriuretic peptide {NT-proBNP) in EDTA or lithium heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care/ near-patient testing and laboratory settings. It is intended for use as an aid in the diagnosis of heart failure. The test is also intended for use as an aid in the risk stratification of patients with acute coronary syndrome and heart failure.

The NTproBNP2 CAL Cartridge is an in vitro diagnostic reagent intended for the calibration adjustment of the NTproBNP2 Test on the AQT90 FLEX analyzer by establishing points of reference to estimate NT-proBNP values.

The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point of care/ near-patient testing and laboratory settings.

Study Timeline

• Study Start: 2025-01-27
• Status Verified: 2025-02
• Primary Completion: 2025-02-05
• Study Completion: 2025-02-05
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 781

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
95th percentile of normal concentrations with 95% confidence intervals (CI) for overall samples	Participants are not involved but the timeframe from plasma sample taken out from freezer to measurement result is approximately 3 hours.	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.

Secondary Outcome Measures

Name	Time	Method
95th percentile for normal concentrations separately for both males and females	Participants are not involved but the timeframe from plasma sample taken out from freezer to measurement result is approximately 3 hours.	The secondary endpoint would be to establish the 95th percentile for normal concentrations separately for both males and females with the 95% confidence intervals.

Trial Locations

Locations (1)

Radiometer Turku Oy; 🇫🇮 Turku, Finland