Harmonization of commercial assays for PINP; the way forward

Details

• Alternative Title:
  Osteoporos Int
• Personal Author:
  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.
• Description:
  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.
  
  
• Subjects:
  Article Biological Assay Biomarkers Bone Resorption Bone Turnover Markers Collagen Type I Harmonization Humans Peptide Fragments Peptides PINP Procollagen Procollagen Type I N-propeptide

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• Source:
  Osteoporos Int. 31(3):409-412
• Pubmed ID:
  31975180
• Pubmed Central ID:
  PMC7080559
• Document Type:
  Journal Article
• Funding:
  MC_U147585827/MRC_/Medical Research Council/United Kingdom ; MC_U147585819/MRC_/Medical Research Council/United Kingdom ; MC_UP_A620_1014/MRC_/Medical Research Council/United Kingdom ; CC999999/ImCDC/Intramural CDC HHS/United States ; MC_UU_12011/1/MRC_/Medical Research Council/United Kingdom ; MR/P020941/1/MRC_/Medical Research Council/United Kingdom ; G0400491/MRC_/Medical Research Council/United Kingdom ; MC_U147585824/MRC_/Medical Research Council/United Kingdom
• Volume:
  31
• Issue:
  3
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:adb8d44ffd6b64f83243b54c78df7cce758b365b40374230ff0480eb29578b88
• Download URL:
  https://stacks.cdc.gov/view/cdc/86016/cdc_86016_DS1.pdf
• File Type:
  [PDF - 444.07 KB ]