Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP
- Conditions
- Heart Failure
- Registration Number
- NCT01808872
- Lead Sponsor
- Radiometer Medical ApS
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 569
- 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
- Subject claim of pregnancy
- Subject's prior participation in this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States