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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 2017: 3.556

CiteScore 2017: 2.34

SCImago Journal Rank (SJR) 2017: 1.114
Source Normalized Impact per Paper (SNIP) 2017: 1.188

Online
ISSN
1437-4331
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Volume 48, Issue 1

Issues

Analytical validation of serum bone alkaline phosphatase (BAP OSTASE) on Liaison

Etienne Cavalier
  • Department of Clinical Chemistry, University of Liege, University Hospital of Liege, Liege, Belgium
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Eric Rozet
  • Department of Analytical Chemistry, University of Liege, Liege, Belgium
  • F.R.S.-FNRS Postdoctoral Researcher (Belgium).
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Agnès Carlisi
  • Department of Clinical Chemistry, University of Liege, University Hospital of Liege, Liege, Belgium
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Anne-Catherine Bekaert
  • Department of Clinical Chemistry, University of Liege, University Hospital of Liege, Liege, Belgium
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Olivier Rousselle
  • Department of Clinical Chemistry, University of Liege, University Hospital of Liege, Liege, Belgium
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Philippe Hubert / Jean-Paul Chapelle
  • Department of Clinical Chemistry, University of Liege, University Hospital of Liege, Liege, Belgium
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  • De Gruyter OnlineGoogle Scholar
/ Pierre Delanaye
  • Department of Nephrology and Dialysis, University of Liege, University Hospital of Liege, Liege, Belgium
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2009-11-30 | DOI: https://doi.org/10.1515/CCLM.2010.019

Abstract

Background: The goal of this study was to validate the DiaSorin Liaison BAP OSTASE, a new method for measurement of bone alkaline phosphatase (BAP), and to compare this method with the Beckman-Coulter Access Ostase. We also wanted to establish the reference range for BAP in adults and children.

Methods: We determined the precision, functional sensitivity, recovery, linearity and measurement uncertainty, accuracy profile and β-expectation limits. We defined an adult reference interval using individuals with 25-OH vitamin D >80 nmol/L, parathormone <58 ng/L, and normal calcium, phosphorous and estimated glomerular filtration rate. Each adult subclass (men/non-menopausal women/menopause women) contained 120 individuals. We also determined the 2.5th and 97.5th percentiles from a population of 450 children, stratified according to age and gender.

Results: The results of the validation showed: precision <6%, functional sensitivity <0.74 μg/L, mean recovery 98.8±4.2% and good linearity. Relative uncertainty ranged from 9.0% to 12.9%, and the risk of one result falling out of the ±15% acceptance limits was <5% for concentrations between 7 and 94 μg/L. The Bland-Altman plot showed no systematic bias between the two methods. In adults, we did not find any statistical difference between the different subclasses. The upper limit of normality observed in the entire population (n=360) was 21.3 μg/L (90% CI: 18.3–24.2 μg/L).

Conclusions: The Liaison BAP OSTASE is a robust method, and is completely validated between 7 and 93 μg/L: in this range, 95% of the values obtained will be within ±15% of the true value.

Clin Chem Lab Med 2010;48:67–72.

Keywords: analytical validation; bone alkaline phosphatase; measurement uncertainty; reference range

About the article

Corresponding author: Dr. Etienne Cavalier, Department of Clinical Chemistry, University Hospital of Liège, Domaine du Sart-Tilman, 4000 Liège, Belgium Phone: +32 4 3667692, Fax: +32 4 3667691,


Received: 2009-08-01

Accepted: 2009-09-02

Published Online: 2009-11-30

Published in Print: 2010-01-01


Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 48, Issue 1, Pages 67–72, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2010.019.

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