Analytical and Clinical Performance Evaluation of a Novel NT-proBNP Assay with De Novo Antibodies across Different Population Groups

BACKGROUND: A new N-terminal pro-B-type natriuretic peptide (NT-proBNP) immunoassay using de novo antibodies was developed on a DxI9000© analyzer from Beckman. The aim of this study was to assess its analytical performance, and a comparison with the Elecsys-proBNPII assay from Roche was also performed. NT-proBNP values in healthy adults based on sex and age were established, and clinical performance in the diagnosis of chronic heart failure (CHF), acute heart failure (AHF), aging, and chronic kidney disease (CKD) populations was evaluated. METHODS: Analytical performance of the Access NT-proBNP assay was evaluated. A method comparison was performed using 200 fresh plasma samples as well as with all the patient samples included in the study (n = 531). The distribution of Access NT-proBNP levels in healthy subjects, patients with CHF or AHF, and patients with CKD was reported. RESULTS: The total imprecision for NT-proBNP controls was 3.17% and 4.73%, and 3.70% and 10.45% in a plasma pool. The limit of blank and limit of detection were lower than those reported by the manufacturer. Correlation studies showed a good correlation between NT-proBNP measurements using the Access NT-proBNP assay and Roche analyzer.In a healthy population, the NT-proBNP concentrations increased across the age groups and significantly varied in healthy adult men and women throughout the years. In the different pathological situations studied, our results clearly demonstrated that the new NT-proBNP assay from Beckman meets European Society of Cardiology requirements for diagnostic approaches and monitoring of patients suspected of having chronic heart failure. CONCLUSION: The Access NT-proBNP assay showed acceptable analytical and diagnostic performance in heart failure. In cases of renal failure, our study encourages cautious interpretation of results.