Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 5/5/2014 |
| Start Date: | March 2013 |
| End Date: | April 2014 |
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.
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
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