Evaluation of Analytical Performances and Comparison of 3 NT-proBNP Assays for Diagnosing Heart Failure

Abstract

center dot Context.-The N-terminal prohormone of the brain natriuretic peptide (NT-proBNP) is a major diagnostic biomarker for heart failure. Objective.-To compare the analytical and clinical performance of 3 NT-proBNP immunoassays: the Atellica IM NT-proBNP assay (Siemens Healthcare Diagnostics), the Alere NT-proBNP assay (Abbott Laboratories), and the Elecsys proBNP II assay (Roche Diagnostics). Design.-For the Atellica IM NT-proBNP assay, analytical performance, including precision, linearity, and carryover, was fully evaluated. Method comparisons among the 3 assays were performed using the PassingBablok regression and the j agreement test. To evaluate the clinical performance of the assays, 160 patient samples were used from patients with (n = 81) or without (n = 79) heart failure. Results.-The analytical performance of the Atellica IM NT-proBNP assay was acceptable according to the manufacturer's claims. The Atellica IM NT-proBNP assay showed a positive bias compared with the Elecsys proBNP II assay. The Cohen j values among the 3 assays were satisfactory (.0.80) and comparable. There were no significant differences in areas under the curve. However, for the diagnosis of heart failure, the Elecsys proBNP II showed a higher specificity and positive likelihood ratio than the other assays. Conclusions.-All 3 NT-proBNP assays showed acceptable concordance, and their clinical performance was comparable. However, the Elecsys proBNP II might be a more discriminating NT-proBNP assay to diagnose heart failure. (Arch Pathol Lab Med. 2023;147:949-956; doi: 10.5858/ arpa.2021-0587-OA)