Analytical and clinical performance of the Ortho-Clinical Diagnostics VITROS amino-terminal pro-B type natriuretic peptide assay.
BACKGROUND
Measurement of amino-terminal pro-B-type natriuretic peptide (NT-proBNP) is useful for evaluating patients with heart failure (HF).


METHODS
We evaluated the performance of a new automated NT-proBNP assay.


RESULTS
The VITROS NT-proBNP assay had mean within-run and total imprecision of 1.0% and 3.4% at NT-proBNP concentrations from 67-27,500 ng/l. Acceptable linearity, functional/analytical sensitivity were demonstrated. Anticoagulant/tube types had no effect on results. Excellent sample stability and no high-dose hook were observed. High correlation between the VITROS and Elecsys methods was demonstrated (r=0.995; P<.001), with 98.3% clinical concordance. VITROS NT-proBNP concentrations were significantly higher in HF subjects than those without (1210 versus 68 ng/l; P<.001) and associated with HF symptom severity (P<.001). The VITROS assay had AUC for HF of 0.95 (P<.001), and had excellent NPV for excluding HF.


CONCLUSIONS
The automated VITROS NT-proBNP assay demonstrates excellent analytical and clinical performance for evaluating the presence and severity of HF.
Januzzi
James L
JL
Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Yawkey 5984, 55 Fruit St. Boston, MA 02114, USA. JJanuzzi@Partners.org
Lewandrowski
Kent B
KB
Bashirians
George
G
Jackson
Shari
S
Freyler
Deb
D
Smith
Katrina
K
Murakami
Maryann M
MM
Apple
Fred S
FS
D006801:Humans; D020097:Natriuretic Peptide, Brain / Q000097:blood*; D011498:Protein Precursors / Q000097:blood*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D011498:Protein Precursors; D020097:Natriuretic Peptide, Brain