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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

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
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

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. 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. 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. 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.

bone marker, bone turnover, bone turnover markers, harmonization, N-terminal propeptide of type I procollagene, propeptide of type I procollagen (PINP)
1434-6621
Cavalier, Etienne
bc312308-1b70-4434-ab15-28860479d2e9
Eastell, Richard
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Rye Jørgensen, Niklas
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Makris, Konstantinos
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Tournis, Symeon
cdcbb48e-2fc1-499e-9eb8-f8e9611c7a8b
Vasikaran, Samuel
3ce2872a-4e12-4835-85a9-c48b734dfa28
Kanis, John A.
f1621d8d-8afb-4d97-9679-2165d88a344d
Cooper, Cyrus
e05f5612-b493-4273-9b71-9e0ce32bdad6
Pottel, Hans
80e23479-69ff-4682-9c54-c703eb0ea762
Morris, Howard A.
cd727ba3-3bcc-44b5-b9be-34d95962b987
Cavalier, Etienne
bc312308-1b70-4434-ab15-28860479d2e9
Eastell, Richard
b19615e4-bc97-4ddf-b8d7-7f48b7220228
Rye Jørgensen, Niklas
1f275e88-62c2-489a-a323-1f31900f548d
Makris, Konstantinos
1d7847d4-7ace-417c-8c5b-c0f892558d47
Tournis, Symeon
cdcbb48e-2fc1-499e-9eb8-f8e9611c7a8b
Vasikaran, Samuel
3ce2872a-4e12-4835-85a9-c48b734dfa28
Kanis, John A.
f1621d8d-8afb-4d97-9679-2165d88a344d
Cooper, Cyrus
e05f5612-b493-4273-9b71-9e0ce32bdad6
Pottel, Hans
80e23479-69ff-4682-9c54-c703eb0ea762
Morris, Howard A.
cd727ba3-3bcc-44b5-b9be-34d95962b987

Cavalier, Etienne, Eastell, Richard, Rye Jørgensen, Niklas, Makris, Konstantinos, Tournis, Symeon, Vasikaran, Samuel, Kanis, John A., Cooper, Cyrus, Pottel, Hans and Morris, Howard A. (2019) 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. Clinical Chemistry and Laboratory Medicine. (doi:10.1515/cclm-2019-0174).

Record type: Article

Abstract

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. 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. 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. 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.

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More information

Accepted/In Press date: 8 April 2019
e-pub ahead of print date: 14 May 2019
Keywords: bone marker, bone turnover, bone turnover markers, harmonization, N-terminal propeptide of type I procollagene, propeptide of type I procollagen (PINP)

Identifiers

Local EPrints ID: 433660
URI: http://eprints.soton.ac.uk/id/eprint/433660
ISSN: 1434-6621
PURE UUID: 7058d5ed-25a3-44dc-bfdf-dc41f2c55db2
ORCID for Cyrus Cooper: ORCID iD orcid.org/0000-0003-3510-0709

Catalogue record

Date deposited: 29 Aug 2019 16:30
Last modified: 26 Nov 2021 02:40

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Contributors

Author: Etienne Cavalier
Author: Richard Eastell
Author: Niklas Rye Jørgensen
Author: Konstantinos Makris
Author: Symeon Tournis
Author: Samuel Vasikaran
Author: John A. Kanis
Author: Cyrus Cooper ORCID iD
Author: Hans Pottel
Author: Howard A. Morris

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