Clinical trial NCT06834880: AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study
Official title: AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Radiometer Medical ApS
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 781
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 95th percentile of normal concentrations with 95% confidence intervals (CI) for overall samples
timeFrame: Participants are not involved but the timeframe from plasma sample taken out from freezer to measurement result is approximately 3 hours.
Secondary outcomes:
measure: 95th percentile for normal concentrations separately for both males and females
timeFrame: Participants are not involved but the timeframe from plasma sample taken out from freezer to measurement result is approximately 3 hours.
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Radiometer Turku Oy
Study officials:
References: