Harmonization of commercial assays for PINP:​ the way forward

Vasikaran, S. D.; Bhattoa, H. P.; Eastell, R.; Heijboer, A. C.; Jørgensen, N. R.; Makris, K.; Ulmer, C.; Kanis, J. A.; Cooper, C.; Silverman, S.; Cavalier, E.

Affiliations

¹PathWest Laboratory Medicine, Fiona Stanley Hospital, Murdoch, Australia

²Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary

³Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK

⁴Department of Clinical Chemistry, Endocrine Laboratory, Amsterdam Gastroenterology & Metabolism, Vrije Universiteit Amsterdam and University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands

⁵Department of Clinical Biochemistry, Rigshospitalet, Glostrup, Denmark

⁶OPEN, Odense Patient data Explorative Network, Odense University Hospital/Institute of Clinical Research, University of Southern Denmark, Odense, Denmark

⁷Clinical Biochemistry Department, KAT General Hospital, Athens, Greece

⁸Laboratory for Research of the Musculoskeletal System “Th. Garofalidis”, Medical School, University of Athens, Athens, Greece

⁹Clinical Chemistry Branch, Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, USA

¹⁰Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, UK

¹¹The MRC Epidemiology Resource Centre, Southampton General Hospital, University of Southampton, Southampton, UK

¹²Cedars-Sinai Medical Center and UCLA School of Medicine, Beverly Hills, USA

¹³Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Domaine du Sart-Tilman, Liège, Belgium

Abstract and keywords

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.

Keywords: Bone resorption; Bone turnover markers; Harmonization; PINP; Procollagen type I N-propeptide

Links

DOI: 10.1007/s00198-020-05310-6

PubMed: 31975180

WoS: 000519860900002

History

Received: 2019-10-31

Accepted: 2020-01-20

Online: 2020-01-23

Cited Works (2)

Year	Entry
2017	Khosla S, Hofbauer LC. Osteoporosis treatment: recent developments and ongoing challenges. Lancet Diabetes Endocrinol. November 2017;5(11):898-907.
2011	Vasikaran S, Eastell R, Bruyère O, Foldes AJ, Garnero P, Griesmacher A, McClung M, Morris HA, Silverman S, Trenti T, Wahl DA, Cooper C, Kanis JA; OF-IFCC Bone Marker Standards Working Group. Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos Int. February 2011;22(2):391-420.

Cited By (2)

Year

Entry

2021

Cavalier E, Eastell R, Jørgensen NR, Makris K, Tournis S, Vasikaran S, Kanis JA, Cooper C, Pottel H, Morris HA; IFCC-IOF Committee for Bone Metabolism (C-BM). A multicenter study to evaluate harmonization of assays for -terminal telopeptides of type I collagen (ß-CTX): a report from the IFCC-IOF committee for bone metabolism (C-BM) [published correction appears in Calcif Tiss Int. June 2021;108(6):825-826]. Calcif Tiss Int. June 2021;108(6):785-797.

2020

Cavalier E, Lukas P, Bottani M, Aarsand AK, Ceriotti F, Coşkun A, Díaz-Garzón J, Fernàndez-Calle P, Guerra E, Locatelli M, Sandberg S, Carobene A; European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation; IOF-IFCC Committee on Bone Metabolism. European Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates of β-isomerized C-terminal telopeptide of type I collagen (β-CTX), N-terminal propeptide of type I collagen (PINP), osteocalcin, intact fibroblast growth factor 23 and uncarboxylated-unphosphorylated matrix-Gla protein: a cooperation between the EFLM Working Group on Biological Variation and the International Osteoporosis Foundation-International Federation of Clinical Chemistry Committee on Bone Metabolism. Osteoporos Int. August 2020;31(8):1461-1470.