Analytical and clinical evaluation of the Bayer ADVIA Centaur automated B-type natriuretic peptide assay in patients with heart failure: a multisite study.
BACKGROUND
B-Type natriuretic peptide (BNP) is released from the left ventricle of the heart into the circulation in response to ventricular stretching and volume overload. Increased BNP concentrations are associated with heart failure (HF).


METHODS
We evaluated the analytical and clinical performance of the Bayer ADVIA Centaur BNP assay. Studies included precision, analytical correlation (against the Shionogi ShionoRIA and Biosite Triage BNP assays), BNP results for blood collected in plastic tubes containing EDTA vs other collection tubes, high-dose hook effect, detection limits, and interferences. The clinical performance was tested on 2243 blood samples collected from 983 apparently healthy individuals, 538 patients with chronic disease but without HF (renal insufficiency, chronic obstructive pulmonary disease, diabetes, and hypertension), and 722 patients with HF (New York Heart Association classes I-IV).


RESULTS
The ADVIA Centaur assay had total imprecision (CV) of 3.4%, 2.9%, and 2.4% at BNP concentrations of 48, 461, and 1768 ng/L, respectively. The Passing-Bablok correlations to the ShionoRIA and Triage were as follows: ADVIA Centaur = 1.11(ShionoRIA) - 1.19 ng/L (r = 0.98); ADVIA Centaur = 0.78(Triage) + 5.89 ng/L (r = 0.92), respectively. Of the different blood collection tubes, only EDTA plastic tubes (with and without the barrier gel) were acceptable. The lower detection limit was 0.5 ng/L, and there were no interferences from common analytes, other neuropeptides, or unusual antibodies. BNP exhibited different reference intervals according to age and gender. BNP concentrations increased progressively as the severity of HF increased.


CONCLUSIONS
The ADVIA Centaur is the first commercially available BNP assay for use on an automated immunochemistry platform. This assay has good analytical and clinical performance characteristics for diagnosing HF.
Wu
Alan H B
AH
Department of Pathology and Laboratory Medicine, Hartford Hospital, 80 Seymour St., Hartford, CT 06102, USA. awu@harthosp.org
Packer
Milton
M
Smith
Andrew
A
Bijou
Rachel
R
Fink
Daniel
D
Mair
Johannes
J
Wallentin
Lars
L
Johnston
Nina
N
Feldcamp
Carolyn S
CS
Haverstick
Doris M
DM
Ahnadi
Charaf E
CE
Grant
Andrew
A
Despres
Normand
N
Bluestein
Barry
B
Ghani
Farooq
F
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001322:Autoanalysis; D005260:Female; D006333:Heart Failure / Q000175:diagnosis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood*; D012372:ROC Curve; D012016:Reference Values; D012680:Sensitivity and Specificity
D020097:Natriuretic Peptide, Brain