Analytical Characterization and Validation of a Novel Automated Amino-Terminal proB-Type Natriuretic Peptide Assay.

Background: N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurement has class 1, level of evidence A recommendations in heart failure (HF) guidelines for diagnosis and prognosis. Analytical characterization of a novel automated NT-proBNP assay is necessary to examine its fitness for validation in pivotal clinical trials.

Methods: The Access NT-proBNP assay is an immunoenzymatic assay using monoclonal capture and detection reagents on the DxI 9000 Immunoassay Analyzer.

A benefit risk approach in cutoff determination for diagnostic tests.

A crucial step in the design of a diagnostic test is determining the cutoff point, the threshold which separates a negative measurement from a positive one. The results of a diagnostic test have clinical consequences: only when disease is accurately detected, proper treatments be administered, and vice versa. Benefit-Risk (BR) analysis should be used to determine the optimal cutoff point that optimizes the consequence.