Clinical value of a competitive NT-proBNP enzyme immunoassay compared to the Roche NT-proBNP platform.

摘要

During the last decade N-terminal pro B-type natriuretic peptide (NT-proBNP) and BNP have become widely accepted by clinicians as helpful parameters in various settings of heart disease. Recently, new guidelines for the clinical utilization of these markers (1) and for diagnosis of acute congestive heart failure (HF) with emphasis on analytical issues (2) have been developed. Commercially available NT-proBNP assays use the same antibodies and calibrators that are licensed from Roche. Thus, these assays correlate very well, but are not in absolute agreement with each other (3, 4). In contrast, the Biomedica assay, which is commercially available in Europe, is the only available assay that uses a different antibody than the Roche assay and is directed against the N-terminus of proBNP (5). Since several studies (6-8) suggest that different fragments of the BNP precursor proBNP may circulate in human blood, these fragments could influence the assay results and impact the diagnostic validity of assays using different antibodies and calibrators. Therefore, the goal of this study was to investigate the diagnostic performance of the Biomedica assay in comparison with the Roche NT-proBNP assay in a large cohort of healthy blood donors and patients with HF.