The automated Elecsys proBNP assay demonstrated good technical performance across multiple platforms and sites, with within- and total precision ≤3% and reproducibility <5%.
Does the automated Elecsys proBNP assay demonstrate adequate technical performance for routine clinical use in diagnosing congestive heart failure?
The Elecsys proBNP assay exhibits strong analytical performance, including high precision and reproducibility, supporting its routine clinical use for heart failure diagnosis.
The purpose of this multicenter study was to evaluate the technical performance of the automated Elecsys proBNP (brain natriuretic peptide) assay, which is indicated as an aid in the diagnosis of individuals suspected of having congestive heart failure. The Elecsys proBNP assay is an electrochemiluminescent immunoassay employing two polyclonal NT-proBNP-specific antibodies in a sandwich test format. The study was performed on the three Elecsys analyzers (E 1010, E 2010, and E 170) at eight different sites world-wide. Within- and total precision were or = 0.998) among the three types of analyzers. Slopes were 4.95 and 4.53 in comparison to the Biosite Triage and Shionogi BNP assays. There was no assay interference, and no effect of barrier gels, tube composition, or freeze-thaw. NT-proBNP concentrations in EDTA plasma were up to 10% lower than in serum or heparinized plasma and the analyte was stable at 4 degrees C for up to 72 hours (the maximum time tested). There was no circadian rhythm in normal subjects or congestive heart failure patients and there was no effect of drawing position. In summary, the Elecsys proBNP assay exhibits good technical performance and is suitable for use in routine clinical laboratories to aid in the diagnosis of congestive heart failure.
Sokoll et al. (2004) studied Congestive heart failure. Elecsys proBNP assay vs. Biosite Triage and Shionogi BNP assays was evaluated on Technical performance (precision, reproducibility, linearity). The automated Elecsys proBNP assay demonstrated good technical performance across multiple platforms and sites, with within- and total precision ≤3% and reproducibility <5%.