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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 57, Issue 6

Issues

Evaluation of analytical performances using standardized analytical protocols and comparison of clinical results of the new ADVIA BNP and NT-proBNP immunoassays for the Centaur XPT platform

Silvia Masotti / Veronica Musetti / Concetta Prontera / Simona Storti / Rudina Ndreu / Claudio Passino / Giancarlo Zucchelli / Aldo Clerico
  • Corresponding author
  • Scuola, Superiore Sant’Anna, Department of Laboratory Medicine, Fondazione G. Monasterio CNR – Regione Toscana, Via Giuseppe Moruzzi 1, 56124 Pisa, Italy
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Published Online: 2018-11-09 | DOI: https://doi.org/10.1515/cclm-2018-0760

Abstract

Background

The study aim was to evaluate and compare analytical performances and clinical results of ADVIA BNP and PBNP methods using the Centaur XPT platform with those of Access BNP, using the DxI platform and the ECLIA NT-proBNP method, using the Cobas e411 platform, respectively.

Methods

Limits of blank (LoB), detection (LoD) and quantitation (LoQ) at 20% CV and 10% CV were evaluated according to international standardized protocols. The analytical parameters were assessed throughout a 90-working-day period using three curve calibrations.

Results

LoB, LoD and LoQ at 20% CV and 10% values of the ADVIA BNP method were 1.0 ng/L, 2.0 ng/L, 3.7 ng/L and 10.2 ng/L, respectively; while those of the ADVIA PBNP method were 1.3 ng/L, 3.0 ng/L, 9.7 ng/L and 22.3 ng/L, respectively. The ADVIA BNP and PBNP methods were able to measure the clinical decision values suggested by international guidelines for diagnosis of heart failure (HF) with an imprecision ≤6%. BNP concentrations measured with the ADVIA and Access methods showed a close linear regression (R=0.9923, n=200); a close linear regression was also found between NT-proBNP concentrations measured with the ADVIA and ECLIA methods (R=0.9954, n=202). However, the ADVIA method measured significantly lower BNP values than the Access method (on average −20.9%), while ADVIA PBNP method measured significantly higher NT-proBNP concentrations than the ECLIA method (on average +17.8%).

Conclusions

Analytical performances of the BNP and PBNP ADVIA methods are well in accordance with the quality specifications required by international guidelines for diagnosis and follow-up of patients with HF.

This article offers supplementary material which is provided at the end of the article.

Keywords: cardiac endocrine function; cardiovascular risk; heart failure; immunoassay methods; natriuretic peptides

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About the article

Corresponding author: Prof. Aldo Clerico, MD, Scuola, Superiore Sant’Anna, Department of Laboratory Medicine, Fondazione G. Monasterio CNR – Regione Toscana, Via Giuseppe Moruzzi 1, 56124 Pisa, Italy, Phone: +39-0585-493569, Fax: +39-0585-493652


Received: 2018-07-19

Accepted: 2018-10-02

Published Online: 2018-11-09

Published in Print: 2019-05-27


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 57, Issue 6, Pages 911–917, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2018-0760.

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