Clearance for automated BNP assay to help diagnosis of heart failure
Fully automated assay for B-type natriuretic peptide runs on the ADVIA Centaur® immunoassay system.
Heart failure is a serious condition, which may not be treated because symptoms are non-specific and this makes diagnosis of disease quite difficult. Symptoms may be confused with other conditions, for example chronic obstructive pulmonary disease. The New York Heart Association (NYHA) Functional Classification is the commonest system for assessing the severity of heart failure. Blood levels of BNP (B-type natriuretic peptide) correlate well with NYHA classification and the severity of heart failure.*
Bayer’s Diagnostics Division of Bayer HealthCare LLC has developed a fully automated test for use as an aid in the diagnosis of heart failure (HF), on its leading automated immunoassay platform -- the ADVIA Centaur Immunoassay System. The US Food and Drug Administration (FDA) has now given Bayer clearance for its assay, which provide physicians with an important diagnostic tool in the early detection and management of heart failure, increasing their confidence in making critical decisions for management of patients with heart failure.
Worldwide, HF is an increasingly significant problem for health care systems, representing a major health care expenditure as it affects nearly 17 million people worldwide. According to American Heart Association data, nearly 5 million Americans suffer with HF, while 550,000 cases are diagnosed each year.
The BNP assay is another test within a comprehensive cardiovascular screening package for CK-MB, troponin I, myoglobin and homocysteine offered on the ADVIA Centaur system, which can report results in less than 20 minutes. The BNP assay has a better than 99% negative predictive value in ruling out heart failure.
ADVIA Centaur® Immunoassay System
ADVIA Centaur® is among the most productive and efficient immunochemistry platforms in the marketplace, as rated by an independent US customer survey. It provides testing for a broad range of conditions, including cardiovascular diseases, cancer, fertility, anaemia, thyroid diseases, allergy, metabolic diseases, therapeutic drug monitoring and infectious diseases.
Reference
* Maisel, Rapid measurement of B-type natriuretic peptide in the emegency diagnosis of heart failure. N. Engl. J. Med. 2002;347:161-167.
About Bayer Diagnostics
Keywords : Bayer HealthCare USA Diagnostics ADVIA Centaur® Immunoassay System B-type natriuretic peptide BNP Heart failure Staging Severity NYHA classification Cardiovascular screening CK-MB troponin-I myoglobin homocysteine
