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Harmonization of commercial assays for PINP; the way forward

Harmonization of commercial assays for PINP; the way forward
Harmonization of commercial assays for PINP; the way forward

Summary: International Federation of Clinical Chemistry and Laboratory Medicine and The International Osteoporosis Foundation Joint Committee on Bone Metabolism believes that the harmonization of PINP assays is an achievable and practical goal. Introduction: In order to examine the agreement between current commercial assays, a multi-center study was performed for PINP in serum and plasma. Methods: The automated methods for PINP (Roche Cobas and IDS iSYS) gave similar results. A significant proportional bias was observed between the two automated assays and the Orion radioimmunoassay (RIA) for PINP. Results: Results from other published studies comparing PINP values among these three assays broadly support our findings. Taken together, these results confirm that harmonized PINP measurements exist between the two automated assays (Roche Cobas and IDS iSYS) when the eGFR is > 30 mL/min/1.73m 2, but a significant bias exists between the Orion RIA and the two automated assays. Conclusion: Therefore, in subjects with normal renal function, PINP results reported by the Roche Cobas and IDS iSYS assays are similar and may be used interchangeably, and similar reference intervals and treatment targets could be applied for the two automated assays. Harmonization between the automated assays and the RIA is potentially possible with the use of common calibrators and the development of a reference method for PINP. This should also help ensure that any new commercial assay developed in the future will attain similar results. IOF and IFCC are committed to working together towards this goal with the cooperation of the reagent manufacturing industry.

Bone resorption, Bone turnover markers, Harmonization, PINP, Procollagen type I N-propeptide
0937-941X
409-412
Vasikaran, Samuel D.
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Bhattoa, Harjit P.
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Eastell, Richard
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Heijboer, Annemieke C.
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Rye Jørgensen, Niklas
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Makris, Konstantinos
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Ulmer, Candice Z.
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Kanis, John A.
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Cooper, Cyrus
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Silverman, Stuart
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Cavalier, Etienne
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Vasikaran, Samuel D.
8b2886f5-545c-4734-949e-26ee91b88176
Bhattoa, Harjit P.
a67d970a-86c6-4bce-bac4-ec8c032c53e4
Eastell, Richard
b19615e4-bc97-4ddf-b8d7-7f48b7220228
Heijboer, Annemieke C.
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Rye Jørgensen, Niklas
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Makris, Konstantinos
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Ulmer, Candice Z.
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Kanis, John A.
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Cooper, Cyrus
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Silverman, Stuart
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Cavalier, Etienne
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Vasikaran, Samuel D., Bhattoa, Harjit P., Eastell, Richard, Heijboer, Annemieke C., Rye Jørgensen, Niklas, Makris, Konstantinos, Ulmer, Candice Z., Kanis, John A., Cooper, Cyrus, Silverman, Stuart and Cavalier, Etienne (2020) Harmonization of commercial assays for PINP; the way forward. Osteoporosis International, 31 (3), 409-412. (doi:10.1007/s00198-020-05310-6).

Record type: Article

Abstract

Summary: International Federation of Clinical Chemistry and Laboratory Medicine and The International Osteoporosis Foundation Joint Committee on Bone Metabolism believes that the harmonization of PINP assays is an achievable and practical goal. Introduction: In order to examine the agreement between current commercial assays, a multi-center study was performed for PINP in serum and plasma. Methods: The automated methods for PINP (Roche Cobas and IDS iSYS) gave similar results. A significant proportional bias was observed between the two automated assays and the Orion radioimmunoassay (RIA) for PINP. Results: Results from other published studies comparing PINP values among these three assays broadly support our findings. Taken together, these results confirm that harmonized PINP measurements exist between the two automated assays (Roche Cobas and IDS iSYS) when the eGFR is > 30 mL/min/1.73m 2, but a significant bias exists between the Orion RIA and the two automated assays. Conclusion: Therefore, in subjects with normal renal function, PINP results reported by the Roche Cobas and IDS iSYS assays are similar and may be used interchangeably, and similar reference intervals and treatment targets could be applied for the two automated assays. Harmonization between the automated assays and the RIA is potentially possible with the use of common calibrators and the development of a reference method for PINP. This should also help ensure that any new commercial assay developed in the future will attain similar results. IOF and IFCC are committed to working together towards this goal with the cooperation of the reagent manufacturing industry.

Text
PINP opinion paper for OI. Revised - Accepted Manuscript
Available under License University of Southampton Accepted Manuscript Licence.
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Accepted/In Press date: 20 January 2020
e-pub ahead of print date: 23 January 2020
Published date: 1 March 2020
Additional Information: Funding Information: RE receives consultancy funding from IDS, Roche Diagnostics, GSK Nutrition, FNIH, Mereo, Lilly, Sandoz, Nittobo, Abbvie, Samsung, Haoma Medica, CL Bio, and Viking and grant funding from Nittobo, IDS, Roche. Amgen, and Alexion. NRJ he has received free reagents for research use from Roche Diagnostics and IDS. JAK reports grant support from Amgen, Lilly, and Radius Health. CC has received lecture fees and honoraria from Amgen, Danone, Eli Lilly, GSK, Kyowa Kirin, Medtronic, Merck, Nestlé, Novartis, Pfizer, Roche, Servier, Shire, Takeda, and UCB outside of the submitted work. SS is a consultant for Radius, Lilly/Pfizer, speaker for Radius, Amgen, and on the advisory boards of Radius, Amgen. EC is a consultant for Diasorin and IDS. Publisher Copyright: © 2020, International Osteoporosis Foundation and National Osteoporosis Foundation.
Keywords: Bone resorption, Bone turnover markers, Harmonization, PINP, Procollagen type I N-propeptide
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Identifiers

Local EPrints ID: 437584
URI: http://eprints.soton.ac.uk/id/eprint/437584
DOI: doi:10.1007/s00198-020-05310-6
ISSN: 0937-941X
PURE UUID: 20984c92-9dde-462f-b2a0-d09276cdaa74
ORCID for Cyrus Cooper: ORCID iD orcid.org/0000-0003-3510-0709

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Date deposited: 06 Feb 2020 17:30
Last modified: 18 Mar 2024 05:04

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Contributors

Author: Samuel D. Vasikaran
Author: Harjit P. Bhattoa
Author: Richard Eastell
Author: Annemieke C. Heijboer
Author: Niklas Rye Jørgensen
Author: Konstantinos Makris
Author: Candice Z. Ulmer
Author: John A. Kanis
Author: Cyrus Cooper ORCID iD
Author: Stuart Silverman
Author: Etienne Cavalier

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