Quality specifications for B-type natriuretic peptide assays.
BACKGROUND
The objective of this report is to improve the quality of immunochemical measurements of B-type natriuretic peptide (BNP) and its N-terminal propeptide (NT-proBNP). 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.


METHODS
A group of cardiac biomarker experts reviewed and abstracted the scientific literature to provide recommendations pertaining to the quality specifications for BNP/NT-proBNP assays.


RESULTS
The evidence-based recommendations encourage manufacturers to endorse and consistently follow the proposed recommendations; encourage that all package inserts for BNP/NT-proBNP immunoassays include uniform information on assay design, preanalytical performance characteristics, analytical performance characteristics, and clinical performance; and encourage regulatory agencies to adopt a minimal and uniform set of criteria for manufacturers to provide when seeking clearance for new and/or improved assays.


CONCLUSIONS
These recommendations address the use of BNP and NT-proBNP as cardiac biomarkers and not their physiologic and/or pathophysiologic relevance.
Apple
Fred S
FS
Department of Laboratory Medicine and Pathology, Hennepin County Medical Center, Minneapolis, MN 55415, USA. fred.apple@co.hennepin.mn.us
Panteghini
Mauro
M
Ravkilde
Jan
J
Mair
Johannes
J
Wu
Alan H B
AH
Tate
Jillian
J
Pagani
Franca
F
Christenson
Robert H
RH
Jaffe
Allan S
AS
D015415:Biomarkers / Q000097:blood; D002138:Calibration; D006801:Humans; D007118:Immunoassay / Q000592:standards*; D020097:Natriuretic Peptide, Brain / Q000097:blood*; D009419:Nerve Tissue Proteins / Q000097:blood*; D010446:Peptide Fragments / Q000097:blood*; D017410:Practice Guidelines as Topic; D011498:Protein Precursors / Q000097:blood*; D011786:Quality Control; D012680:Sensitivity and Specificity
D015415:Biomarkers; D009419:Nerve Tissue Proteins; D010446:Peptide Fragments; D011498:Protein Precursors; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain