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Elecsys (R) ProBNP immunoassay for the diagnosis of congestive heart failure |
Bywood P, Merlin T, Braunack-Mayer A, Hiller J E |
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Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Bywood P, Merlin T, Braunack-Mayer A, Hiller J E. Elecsys (R) ProBNP immunoassay for the diagnosis of congestive heart failure. Adelaide: Adelaide Health Technology Assessment (AHTA). 2004 Authors' conclusions Congestive heart failure (CHF), which occurs when the heart fails to fill normally or to expel blood effectively, is characterised by breathlessness and oedema. CHF is a major health problem in Australia, accounting for more than 2,500 deaths and over 40,000 hospitalisations per year. Echocardiography, the 'gold standard' diagnostic technique for CHF, provides detailed information on ventricular function and structure and is a safe, relatively non-invasive method for detecting ventricular dysfunction. However, it is not always available and patients frequently find it uncomfortable to lay flat during the procedure.The Elecsys® proBNP immunoassay is a fully automated diagnostic assay that detects the protein molecule NT-proBNP in the blood. NT-proBNP is the inactive fragment of the cardiac neurohormone, BNP, which is released in response to cardiac distension. Levels of NT-proBNP in blood and plasma increase proportionally with disease severity and NT-proBNP has been proposed as a diagnostic indicator for heart failure.Importantly, as symptoms of CHF are also present in other conditions and misdiagnosis is common, the NT-proBNP assay allows clinicians to rapidly differentiate between heart failure and other conditions, such as pulmonary oedema.Six studies investigated the diagnostic accuracy of the Elecsys® proBNP immunoassay compared to standard clinical assessment, including echocardiography. The most salient finding from these studies was that NTproBNP testing has high negative predictive value (>92%), making it an excellent rule-out test in suspected cases. Patients suspected of having heart failure can then be selected for further investigation by echocardiography or other tests on the basis of having an elevated plasma concentration of NT-proBNP. If concentrations are normal, it is likely that symptoms (dyspnoea, oedema) are due to other causes. The added value of an objective measure of NT-proBNP is that it identifies those at greatest risk of future serious cardiovascular events, including death. Normal concentrations of NT-proBNP virtually excludes diagnosis of CHF. Cardiologists may prefer echocardiography, which requires high-level interpretative skills, as it provides more detailed information on cardiac structure and function. Typically, however, it is the non-cardiologist in the emergency department or primary care setting who must decide which patients to refer for echocardiography. An accurate and relatively quick rule-out test would decrease unnecessary echocardiography. Based on current findings, the NT-proBNP test could play a role in pre-screening patients for echocardiography.Six studies, which compared the Elecsys® proBNP assay with BNP assays, showed similar results, with sensitivity and diagnostic accuracy equivalent for both NTproBNP and BNP assays. However, the NT-proBNP appeared to be more accurate than BNP in detecting CHF in asymptomatic patients, and in those with less severe CHF, suggesting NT-proBNP may be a more discerning diagnostic marker at an earlier stage of the disease. INAHTA brief and checklist Indexing Status Subject indexing assigned by CRD MeSH Heart Failure /blood /diagnosis; Immunoassay /methods; Natriuretic Peptide, Brain /blood; Peptide Fragments /blood Language Published English Country of organisation Australia English summary An English language summary is available. Address for correspondence Department of Public Health, Mail Drop 511, University of Adelaide, Adelaide SA 5005, AUSTRALIA, Tel: +61 8 8303 3575, Fax: +61 8 8223 4075 Email: tracy.merlin@adelaide.edu.au AccessionNumber 32006000585 Date bibliographic record published 16/05/2006 Date abstract record published 16/05/2006 |
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