Comparison of BNP measurement reagents from three companies using fully automated immunoassay analyzers and evaluation of BNP Control Shionogi as the quality control material

Abstract

Brain natriuretic peptide (BNP) is useful for the diagnosis and severity assessment of heart failure; however, differences among measurement reagents remain a challenge. This study evaluated LUMIPULSE Presto BNP (Fujirebio Inc.), AIA-Pack CL BNP (Tosoh Corporation), and ARCHITECT BNP-JP (Abbott Japan LLC) using 90 patient plasma samples, manufacturer-specific controls, and BNP Control Shionogi to examine inter-assay correlations and the validity of control materials. Correlation analysis showed strong agreement among the three systems (r = 0.98 or higher), but significant differences in measurement values were observed (p < 0.0001). Manufacturer-specific controls produced results that did not align with patient-sample correlation trends, whereas BNP Control Shionogi demonstrated a possibility of showing reagent-to-reagent relationships similar to those of patient samples. No lot-to-lot differences were observed for LUMIPULSE Presto BNP and BNP Control Shionogi. These findings indicate that BNP Control Shionogi is useful as a quality control material and is expected to contribute to identifying inter-assay differences and promoting harmonization.