Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP

Clinical Sensitivity and Specificity Study of AQT90 FLEX BNP and NT-proBNP

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Subject claim of pregnancy
• Subject's prior participation in this study