Analytical and clinical performance of the Ortho-Clinical Diagnostics VITROS amino-terminal pro-B type natriuretic peptide assay.


Journal Article

BACKGROUND: Measurement of amino-terminal pro-B-type natriuretic peptide (NT-proBNP) is useful for evaluating patients with heart failure (HF). METHODS: We evaluated the performance of a new automated NT-proBNP assay. RESULTS: The VITROS NT-proBNP assay had mean within-run and total imprecision of 1.0% and 3.4% at NT-proBNP concentrations from 67-27,500 ng/l. Acceptable linearity, functional/analytical sensitivity were demonstrated. Anticoagulant/tube types had no effect on results. Excellent sample stability and no high-dose hook were observed. High correlation between the VITROS and Elecsys methods was demonstrated (r=0.995; P<.001), with 98.3% clinical concordance. VITROS NT-proBNP concentrations were significantly higher in HF subjects than those without (1210 versus 68 ng/l; P<.001) and associated with HF symptom severity (P<.001). The VITROS assay had AUC for HF of 0.95 (P<.001), and had excellent NPV for excluding HF. CONCLUSIONS: The automated VITROS NT-proBNP assay demonstrates excellent analytical and clinical performance for evaluating the presence and severity of HF.

Full Text

Duke Authors

Cited Authors

  • Januzzi, JL; Lewandrowski, KB; Bashirians, G; Jackson, S; Freyler, D; Smith, K; Murakami, MM; Apple, FS

Published Date

  • January 2008

Published In

Volume / Issue

  • 387 / 1-2

Start / End Page

  • 48 - 54

PubMed ID

  • 17915201

Pubmed Central ID

  • 17915201

International Standard Serial Number (ISSN)

  • 0009-8981

Digital Object Identifier (DOI)

  • 10.1016/j.cca.2007.08.018


  • eng

Conference Location

  • Netherlands