AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study (RI)
AQT90 FLEX NTproBNP2 Test Kit - 23004 - Reference Interval Study Protocol
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Turku, Finland, 20750
- Radiometer Turku Oy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Healthy population
ADLM universal sample bank from healthy individuals are used in the study.
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Sample bank with Health Questionnaire
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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95th percentile of normal concentrations with 95% confidence intervals (CI) for overall samples
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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95th percentile for normal concentrations separately for both males and females
Time Frame: Baseline
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The secondary endpoint would be to establish the 95th percentile for normal concentrations separately for both males and females with the 95% confidence intervals.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC-087455
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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