Performance characteristics of the Architect® brain natriuretic peptide (BNP) assay: A two site study

Introduction: Brain natriuretic peptide (BNP) is produced by the ventricles of the heart and is a biomarker for heart failure. Several commercial assays are now available. We evaluated the performance characteristics of the ARCHITECT® BNP assay. Methods: We evaluated the limit of blank, limit of detection, linearity and imprecision. Method comparison studies were performed with 3 other automated BNP assays including the ADVIA Centaur®, AxSYM®, and UniCel DxI® 800 methods. Results: The mean LOB and LOD of the Architect assay were 3.5 and 5.8 ng/L, respectively. Imprecision studies yielded within run CVs of 1.1 to 5.1% and total CVs of 2.3 to 5.3% using human plasma based multi-constituent controls at concentrations of 92, 500, and 3500 ng/L. The maximum deviation from the target recovery for dilution linearity was 9.6%. Concordance with other BNP assays at a 100 ng/l cutoff was 91 to 98% and κ statistics were 0.78 to 0.96. The mean difference between the Architect and Advia Centaur methods was positive. For the other methods, the mean difference with the Architect was negative. Conclusions: The Architect BNP assay shows good performance characteristics with total imprecision ≤ 5.3%. It agrees well with the Advia Centaur, AxSYM, and UniCel DxI BNP assays. © 2008 Elsevier B.V. All rights reserved.