Diagnostic Test
Conditions
Brief summary
The purpose of this study is to verify performance claims for method comparison for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer in whole blood (WB) and plasma (PL).
Interventions
None listed
Sponsors
Radiometer Medical ApS
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 assay.
Exclusion criteria
* Subjects known to be pregnant or breast-feeding. * Subjects previously enrolled in the study. * Subject, who has withdrawn consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slope, R | 5 month | Slope, R, for NTproBNP2 Test Kit on the AQT90 FLEX analyzer vs. Elecsys proBNP II assay across sites |
Countries
Spain
Outcome results
None listed