Clinical Performance Evaluation 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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Clinical Sensitivity and Specificity Study of AQT90 FLEX BNP and NT-proBNP|
- 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 ] [ Designated as safety issue: No ]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).
|Study Start Date:||March 2013|
|Study Completion Date:||May 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01808872
|United States, North Carolina|
|Wake Forest University|
|Winston-Salem, North Carolina, United States, 27109|