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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

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1437-4331
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Volume 57, Issue 10

Issues

A multicenter study to evaluate harmonization of assays for N-terminal propeptide of type I procollagen (PINP): a report from the IFCC-IOF Joint Committee for Bone Metabolism

Etienne Cavalier
  • Corresponding author
  • Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Domaine du Sart-Tilman, B-4000 Liège, Belgium
  • Email
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/ Richard Eastell / Niklas Rye Jørgensen
  • Department of Clinical Biochemistry, Rigshospitalet, Glostrup, Denmark
  • OPEN, Odense Patient Data Explorative Network, Odense University Hospital/Institute of Clinical Research, University of Southern Denmark, Odense, Denmark
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/ Konstantinos Makris
  • Clinical Biochemistry Department, KAT General Hospital, Athens, Greece
  • Laboratory for Research of the Musculoskeletal System “Th. Garofalidis”, Medical School, University of Athens, Athens, Greece
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/ Symeon Tournis
  • Laboratory for Research of the Musculoskeletal System “Th. Garofalidis”, Medical School, University of Athens, Athens, Greece
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/ Samuel Vasikaran / John A. Kanis / Cyrus Cooper
  • The MRC Epidemiology Resource Centre, Southampton General Hospital, University of Southampton, Southampton, UK
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/ Hans Pottel
  • Department of Public Health and Primary Care, KU Leuven Campus Kulak Kortrijk, Kortrijk, Belgium
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/ Howard A. Morris
  • School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia
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/
Published Online: 2019-05-14 | DOI: https://doi.org/10.1515/cclm-2019-0174

Abstract

Background

Biochemical bone turnover markers (BTM) are useful tools to assess bone remodeling at the cellular level. N-terminal propeptide of type I procollagen (PINP) has been recommended as a reference marker for bone formation in research studies.

Methods

We describe the results of a multicenter study for routine clinical laboratory assays for PINP in serum and plasma. Four centers (Athens, Greece [GR], Copenhagen, Denmark [DK], Liege, Belgium [BE] and Sheffield, United Kingdom [UK]) collected serum and plasma (EDTA) samples from 796 patients presenting to osteoporosis clinics. Specimens were analyzed in duplicate with each of the available routine clinical laboratory methods according to the manufacturers’ instructions. Passing-Bablok regressions, Bland-Altman plots, V-shape evaluation method and the concordance correlation coefficient for PINP values between serum and plasma specimens and between methods were used to determine the agreement between results. A generalized linear model was employed to identify possible variables that affected the relationship between the methods.

Results

We showed that both EDTA plasma and serum were suitable for PINP determination. We observed a significant proportional bias between Orion radioimmunoassay and the automated methods for PINP (Roche Cobas and IDS iSYS), which both gave very similar results. The multivariate model did not improve the excellent correlation that was observed between the methods.

Conclusions

Harmonization of PINP assays is possible by applying a correction factor or correctly assigning the values of the calibrators. This work will benefit from further collaboration between assays manufacturers and clinical laboratory professionals.

Keywords: bone marker; bone turnover; bone turnover markers; harmonization; N-terminal propeptide of type I procollagene; propeptide of type I procollagen (PINP)

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About the article

Received: 2019-02-13

Accepted: 2019-04-08

Published Online: 2019-05-14

Published in Print: 2019-09-25


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 10, Pages 1546–1555, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2019-0174.

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