Evaluation of the analytical performance characteristics of the Bayer ACS:180 B-type natriuretic peptide (BNP) assay.
BACKGROUND
B-type natriuretic peptide (BNP) is a cardiac hormone that regulates hemodynamic equilibrium and alleviates ventricular stress. In patients with chronic heart failure, BNP levels increase in proportion to the severity of clinical symptoms and degree of decreased left ventricular ejection fraction. BNP has clinical utility in the evaluation, management, and prognosis of patients with heart failure.


METHODS
We evaluated the analytical performance characteristics of the BNP immunochemiluminometric assay in the ACS:180 instrument at three hospital laboratory sites. The analytical performance characteristics evaluated included imprecision, sensitivity (minimum detectable concentration, MDC), analytical measurement range (AMR), dilution linearity/recovery, lot-to-lot reagent variation, high-dose hook effect, and comparison against ADVIA Centaur BNP results on patients' EDTA-plasma samples.


RESULTS
Total imprecision was <10% coefficient of variation at BNP concentrations of 43-1830 pg/ml; MDC was 6.9 pg/ml; AMR was 6.9-5000 pg/ml; overall recovery of BNP in samples diluted up to 1:10 was 98%; there was no lot-to-lot reagent variation in BNP results and no high-dose hook effect at BNP concentrations up to 100,000 pg/ml; and, ACS:180 results were highly correlated (r=0.996) with Centaur BNP results.


CONCLUSIONS
The ACS:180 BNP assay demonstrated excellent analytical performance characteristics and agreement with BNP results obtained using the Centaur instrument.
Wians
Frank H
FH
Department of Pathology, The University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390, United States. Frank.Wians@UTSouthwestern.edu
Wilson
Betty Anne
BA
Grant
Andrew
A
Bailey
Jonathan
J
Gheorghiu
Ionela
I
Conarpe
Carla
C
Mindicino
Henry
H
Thakur
Kiran
K
Belenky
Alexander
A
Despres
Normand
N
Bluestein
Barry
B
D002303:Cardiac Output, Low / Q000097:blood; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007755:Laboratories, Hospital; D020097:Natriuretic Peptide, Brain / Q000097:blood*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D020097:Natriuretic Peptide, Brain