Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The AQT90 FLEX B-type Natriuretic Peptide (BNP) and N-terminal pro B-type natriuretic peptide (NT-proBNP) Tests are in vitro diagnostic assays intended as an aid in the diagnosis and assessment of the severity of heart failure in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX BNP and NT-proBNP assays for both whole blood and plasma in the intended use population.
Determination of the clinical sensitivity and specificity of the AQT90 FLEX BNP and NT-proBNP assays at the clinical cut-off in heart failure patients [ Time Frame: Single blood draw upon study entry ]
Clinical sensitivity and specificity with 95 % confidence intervals of the AQT90 FLEX BNP and NT-proBNP assays will be determined at the clinical cut-off in heart failure patients divided by age, gender and New York Heart Association (NYHA) functional classification.
Biospecimen Retention: Samples Without DNA
Samples are retained only for this study (troubleshooting purposes).
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Ages Eligible for Study:
21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects 21 years of age or older with heart failure
Subject is 21 years of age or older
Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study
Subject has diagnosis of heart failure
Subject has Acute Coronary Syndrome (ACS)
Subject has been diagnosed and/or treated for malignancy within past 6 months
Subject has had cardiac surgery within the past 4 weeks