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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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1437-4331
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Volume 42, Issue 8

Issues

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 / Christiana Zingler
Published Online: 2011-09-21 | DOI: https://doi.org/10.1515/CCLM.2004.157

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

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About the article

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:


Received: 2004-03-01

Accepted: 2004-05-17

Published Online: 2011-09-21

Published in Print: 2004-08-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 42, Issue 8, Pages 965–972, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2004.157.

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