Harmonization of commercial assays for PINP; the way forward

[en] 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/1.73m2, 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. © 2020, International Osteoporosis Foundation and National Osteoporosis Foundation.

Disciplines :

Laboratory medicine & medical technology

Author, co-author :

Vasikaran, Samuel; PathWest Laboratory Medicine, Fiona Stanley Hospital, Murdoch, WA, Australia

Bhattoa, Harjit Pal; Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary

Eastell, R.; Mellanby Centre for Bone Research, University of Sheffield, Sheffield, United Kingdom

Heijboer, A. C.; Department of Clinical Chemistry, Endocrine Laboratory, Amsterdam Gastroenterology & Metabolism, Vrije Universiteit Amsterdam and University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands

Jørgensen, Niklas Rye; Department of Clinical Biochemistry, Rigshospitalet, Glostrup, DK-2600, Denmark, OPEN, Odense Patient data Explorative Network, Odense University Hospital/Institute of Clinical Research, University of Southern Denmark, Odense, DK-8000, Denmark

Makris, Konstantinos; Clinical Biochemistry Department, KAT General Hospital, Athens, 14561, Greece, Laboratory for Research of the Musculoskeletal System “Th. Garofalidis”, Medical School, University of Athens, Athens, Greece

Ulmer, C.; Clinical Chemistry Branch, Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Buford, Atlanta, GA, United States

Kanis, John A.; Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, United Kingdom

Cooper, Cyrus; The MRC Epidemiology Resource Centre, Southampton General Hospital, University of Southampton, Southampton, United Kingdom

Silverman, Stuart S.; Cedars-Sinai Medical Center and UCLA School of Medicine, Beverly Hills, CA, United States

Cavalier, Etienne ; Université de Liège - ULiège > Département de pharmacie > Chimie médicale

Language :

English

Title :

Harmonization of commercial assays for PINP; the way forward

Publication date :

2020

Journal title :

Osteoporosis International

ISSN :

0937-941X

eISSN :

1433-2965

Publisher :

Springer

Peer reviewed :

Peer Reviewed verified by ORBi

Funders :

FNIH - Foundation for the National Institutes of Health
IDS - Immunodiagnostic Systems Holdings
Roche [BE]

Available on ORBi :

since 13 February 2020

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