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

Research paper by James L JL Januzzi, Kent B KB Lewandrowski, George G Bashirians, Shari S Jackson, Deb D Freyler, Katrina K Smith, Maryann M MM Murakami, Fred S FS Apple

Indexed on: 05 Oct '07Published on: 05 Oct '07Published in: Clinica Chimica Acta



Abstract

Measurement of amino-terminal pro-B-type natriuretic peptide (NT-proBNP) is useful for evaluating patients with heart failure (HF).We evaluated the performance of a new automated NT-proBNP assay.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.The automated VITROS NT-proBNP assay demonstrates excellent analytical and clinical performance for evaluating the presence and severity of HF.