S D Vasikaran1, H P Bhattoa2, R Eastell3, A C Heijboer4, N R Jørgensen5,6, K Makris7,8, C Ulmer9, J A Kanis10, C Cooper11, S Silverman12, E Cavalier13. 1. PathWest Laboratory Medicine, Fiona Stanley Hospital, Murdoch, WA, Australia. samuel.vasikaran@health.wa.gov.au. 2. Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary. 3. Mellanby Centre for Bone Research, University of Sheffield, Sheffield, UK. 4. Department of Clinical Chemistry, Endocrine Laboratory, Amsterdam Gastroenterology & Metabolism, Vrije Universiteit Amsterdam and University of Amsterdam, Amsterdam UMC, Amsterdam, Netherlands. 5. Department of Clinical Biochemistry, Rigshospitalet, DK-2600, Glostrup, Denmark. 6. OPEN, Odense Patient data Explorative Network, Odense University Hospital/Institute of Clinical Research, University of Southern Denmark, DK-8000, Odense, Denmark. 7. Clinical Biochemistry Department, KAT General Hospital, 14561, Athens, Greece. 8. Laboratory for Research of the Musculoskeletal System "Th. Garofalidis", Medical School, University of Athens, Athens, Greece. 9. Clinical Chemistry Branch, Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Buford, Atlanta, GA, USA. 10. Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, UK. 11. The MRC Epidemiology Resource Centre, Southampton General Hospital, University of Southampton, Southampton, UK. 12. Cedars-Sinai Medical Center and UCLA School of Medicine, Beverly Hills, CA, USA. 13. Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, Domaine du Sart-Tilman, B-4000, Liège, Belgium.
Abstract
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.
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.
Entities:
Keywords:
Bone resorption; Bone turnover markers; Harmonization; PINP; Procollagen type I N-propeptide
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