Quality Specifications for B-Type Natriuretic Peptide Assays (Special Report‪)‬

The objective of this report is to improve the quality of immunochemical measurements of B-type natriuretic peptide (BNP) [9] and its N-terminal propeptide (NT-proBNP; Table 1). The recommendations proposed are intended for use by manufacturers of commercial assays, by clinical laboratories using those assays, by clinical trial groups and research investigators, and by regulatory agencies, such as the United States Food and Drug Administration (FDA). The main objectives are as follows: * For manufacturers to endorse and then consistently follow the proposed recommendations;