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Multicenter analytical performance evaluation of the Elecsys® proBNP assay

  • Lori J. Sokoll , Hannsjörg Baum , Paul O. Collinson , Eberhard Gurr , Markus Haass , Hilmar Luthe , James J. Morton , William Nowatzke and Christiana Zingler
Published/Copyright: September 21, 2011
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 42 Issue 8

Abstract

The purpose of this multicenter study was to evaluate the technical performance of the automated Elecsys proBNP (brain natriuretic peptide) assay, which is indicated as an aid in the diagnosis of individuals suspected of having congestive heart failure. The Elecsys proBNP assay is an electrochemiluminescent immunoassay employing two polyclonal NT-proBNP-specific antibodies in a sandwich test format. The study was performed on the three Elecsys analyzers (E 1010, E 2010, and E 170) at eight different sites world-wide. Within- and total precision were ≤3%, with total precision slightly higher on the Elecsys E 170 instrument with multiple modules. Reproducibility among sites and platforms was <5%. Precision at particularly low NT-proBNP concentrations was assessed down to approximately 25 pg/ml with CVs of 12.6% at 29.2 pg/ml and 9.6% at 38.5 pg/ml for the Elecsys 1010/2010 and E 170, respectively. Linearity was evaluated up to 25,000 pg/ml with a sample-based non-linear response observed with recoveries of <90% for proBNP concentrations <10 000 pg/ml. Slopes ranged between 0.92 and 1.02 and intercepts from –5.3 to 10.4 pg/ml (r≥0.998) among the three types of analyzers. Slopes were 4.95 and 4.53 in comparison to the Biosite Triage and Shionogi BNP assays. There was no assay interference, and no effect of barrier gels, tube composition, or freeze-thaw. NT-proBNP concentrations in EDTA plasma were up to 10% lower than in serum or heparinized plasma and the analyte was stable at 4°C for up to 72 hours (the maximum time tested). There was no circadian rhythm in normal subjects or congestive heart failure patients and there was no effect of drawing position. In summary, the Elecsys proBNP assay exhibits good technical performance and is suitable for use in routine clinical laboratories to aid in the diagnosis of congestive heart failure.

Keywords: analytical performance; brain natriuretic peptide (BNP); congestive heart failure; NT-proBNP; proBNP
Corresponding author: Lori J. Sokoll, PhD, Johns Hopkins Medical Institutions, 600 N. Wolfe St., Meyer B-125; Baltimore, MD 21287, USA. Phone: +1 410-955-2673, Fax: +1 410-614-7609, E-mail:

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Received: 2004-3-1
Accepted: 2004-5-17
Published Online: 2011-9-21
Published in Print: 2004-8-1

© Walter de Gruyter

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https://doi.org/10.1515/CCLM.2004.157
Keywords for this article
analytical performance; brain natriuretic peptide (BNP); congestive heart failure; NT-proBNP; proBNP

Articles in the same Issue

  1. Rapid detection of the factor XIII Val34Leu (163 G→T) polymorphism by real-time PCR using fluorescence resonance energy transfer detection and melting curve analysis
  2. Changes of matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) in the serum of patients with autoimmune diseases: association with age and disease activity
  3. A recombinant cell bioassay for measurement of overall estrogenic activity of serum: preliminary results in women with breast cancer
  4. N-terminal pro-atrial natriuretic peptide as a biochemical marker of long-term interventional success after radiofrequency catheter ablation of paroxysmal supraventricular tachyarrhythmias
  5. Preventing in vitro lipoperoxidation in the malondialdehyde-thiobarbituric assay
  6. Oxidative stress: potential of distinct peroxide determination systems
  7. Quality assessment in cytogenetic and molecular genetic testing: the experience of the Italian Project on Standardisation and Quality Assurance
  8. Guidelines for blood smear preparation and staining procedure for setting up an external quality assessment scheme for blood smear interpretation. Part I: control material
  9. Measurement of serum and plasma osmolality in healthy young humans – influence of time and storage conditions
  10. High in-hospital mortality of intensive care patients with nucleated red blood cells in blood
  11. Frequency of –163 C > A and 63 C > G single nucleotide polymorphism of cytochrome P450 1A2 in two African populations
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  13. Plasma or serum samples: measurements of cardiac troponin T and of other analytes compared
  14. Antioxidant capacity of the human pericardial fluid: does gender have a role?
  15. Comparison of serum digoxin concentration monitoring by fluorescence polarization immunoassay on the TDxFLx® and dry chemistry enzyme immunoassay on the Vitros 950
  16. Multicenter analytical performance evaluation of the Elecsys® proBNP assay
  17. Analytical evaluation and reference values of serum amyloid-A on the BN ProSpec
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  21. Serum total glutathione-S-transferase in stroke, a preliminary report
  22. Santorini Biologie Prospective Conference 2004 “From Human Genetic Variations to Prediction of Risks and Responses to the Environment”, Santorini, Greece, September 30–October 4, 2004
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