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Received on September 15, 2003
Accepted on February 13, 2004
Lipids, Lipoproteins, and Cardiovascular Risk Factors |
1 Department of Pathology and Laboratory Medicine, Hartford Hospital, 80 Seymour St., Hartford, CT 06102
2 Departments of Medicine and Pathology, Columbia Presbyterian Medical Center, New York, NY
3 Department of Internal Medicine/Division of Cardiology, University of Innsbruck, Innsbruck, Austria
4 Uppsala Clinical Research Center
5 Department of Cardiology, Cardiothoracic Center, Uppsala University Hospital, Uppsala, Sweden
6 Pathology Department, Henry Ford Hospital, Detroit, MI
7 Department of Pathology, University of Virginia, Charlottesville, VA
8 Centre for Research and Evaluation in Diagnostics, CRED, Sherbrooke, Quebec, Canada
9 Bayer Healthcare LLC, Diagnostics Division, Tarrytown, NY
* To whom correspondence should be addressed. E-mail: awu{at}harthosp.org.
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 ShionoRIATM and Biosite Triage® BNP assays), recovery of BNP from 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.
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