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

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