Skip to main content

Harmonization of commercial assays for PINP; the way forward

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/1.73m2, 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.

This is a preview of subscription content, access via your institution.

Fig. 1

References

  1. 1.

    Consensus Development Conference (1993) Diagnosis, prophylaxis, and treatment of osteoporosis. Am J Med 94:646–650

    Article  Google Scholar 

  2. 2.

    Cheng SY, Levy AR, Lefaivre KA, Guy P, Kuramoto L, Sobolev B (2011) Geographic trends in incidence of hip fractures: a comprehensive literature review. Osteoporos Int 22:2575–2586

    CAS  Article  Google Scholar 

  3. 3.

    Khosla S, Hofbauer LC (2017) Osteoporosis treatment: recent developments and ongoing challenges. Lancet Diabetes Endocrinol 5:898–907

    Article  Google Scholar 

  4. 4.

    Eastell R, Pigott T, Gossiel F, Naylor KE, Walsh JS, Peel NF (2018) Diagnosis of endocrine disease: bone turnover markers: are they clinically useful? Eur J Endocrinol 178:R19–R31

    CAS  Article  Google Scholar 

  5. 5.

    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, IOF-IFCC Bone Marker Standards Working Group (2011) Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos Int 22:391–420

    CAS  Article  Google Scholar 

  6. 6.

    Linkhart SG, Linkhart TA, Taylor AK, Wergedal JE, Bettica P, Baylink DJ (1993) Synthetic peptide-based immunoassay for amino-terminal propeptide of type I procollagen: application for evaluation of bone formation. Clin Chem 39:2254–2258

    CAS  Article  Google Scholar 

  7. 7.

    Koivula MK, Risteli L, Risteli J (2012) Measurement of aminoterminal propeptide of type I procollagen (PINP) in serum. Clin Biochem 45:920–927

    CAS  Article  Google Scholar 

  8. 8.

    Cavalier E, Eastell R, Rye Jørgensen N, Makris K, Tournis S, Vasikaran S, Kanis JA, Cooper C, Pottel H, Morris HA, IFCC-IOF Joint Committee for Bone Metabolism (C-BM), IFCC-IOF Joint Committee for Bone Metabolism (C-BM) (2019) A multicenter study to evaluate harmonization of assays for N-terminal propeptide of type I procollagen (PINP): a report from the IFCC-IOF joint committee for bone metabolism. Clin Chem Lab Med 57:1546–1555

    CAS  Article  Google Scholar 

  9. 9.

    Koivula MK, Richardson J, Leino A, Valleala H, Griffiths K, Barnes A et al (2010) Validation of an automated intact N-terminal propeptide of type I procollagen (PINP) assay. Clin Biochem 43:1453–1457

    CAS  Article  Google Scholar 

  10. 10.

    Jørgensen NR, Møllehave LT, Hansen YBL, Quardon N, Lylloff L, Linneberg A (2017) Comparison of two automated assays of BTM (CTX and P1NP) and reference intervals in a Danish population. Osteoporos Int 28:2103–2113

    Article  Google Scholar 

Download references

Funding

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.

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease Registry. Use of trade names is for identification only and does not imply endorsement by the Centers for Disease Control and Prevention, the Public Health Service, and the US Department of Health and Human Services.

Author information

Affiliations

Authors

Corresponding author

Correspondence to S. D. Vasikaran.

Ethics declarations

Conflicts of interest

None.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Vasikaran, S., Bhattoa, H., Eastell, R. et al. Harmonization of commercial assays for PINP; the way forward. Osteoporos Int 31, 409–412 (2020). https://doi.org/10.1007/s00198-020-05310-6

Download citation

Keywords

  • Bone resorption
  • Bone turnover markers
  • Harmonization
  • PINP
  • Procollagen type I N-propeptide