Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
ISSN
1437-4331
See all formats and pricing
More options …
Volume 57, Issue 2

Issues

Moving from the second to the third generation Roche PTH assays: what are the consequences for clinical practice?

Anne Marie Dupuy
  • Laboratoire de Biochimie et Hormonologie, CHU Montpellier, University Montpellier 1, Montpellier, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Anne Sophie Bargnoux
  • Laboratoire de Biochimie et Hormonologie, CHU de Montpellier, PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Marion Morena
  • Laboratoire de Biochimie et Hormonologie, CHU de Montpellier, PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Emilie Lauret
  • Laboratoire de Biochimie et Hormonologie, CHU Montpellier, University Montpellier 1, Montpellier, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Jean Claude Souberbielle
  • Service d’explorations fonctionnelles, Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris, Université René Descartes (Paris V), Paris, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Etienne Cavalier / Jean Paul Cristol
  • Corresponding author
  • Laboratoire de Biochimie et Hormonologie, CHU Montpellier, University Montpellier 1, 371 Avenue Doyen Gaston Giraud, Montpellier 34295, France
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2018-09-05 | DOI: https://doi.org/10.1515/cclm-2018-0300

Abstract

Background

The determination of parathyroid hormone (PTH) is essential for exploring phosphocalcic disorders especially in patients with renal failure. At present, second or third generation PTH assays are available on the market from Roche Diagnostics as well as from others companies but the lack of standardization has complicated the interpretation.

Methods

We wanted to assess the clinical impact by measuring the PTH levels with the two generations concomitantly on different groups of populations including 46 healthy, 103 pre-dialyzed and 73 hemodialyzed (HD) patients.

Results

In healthy subjects, the PTH concentrations were not different whatever the generation used, whereas beyond 200 pg/mL, we reported an overestimation of the second generation PTH. In patients with chronic kidney disease (CKD) stage 3–5 the observed differences between the two generations increase with increasing PTH levels and decreasing glomerular filtration rate (GFR). Classification according to the kidney disease: improving global outcomes (KDIGO) revealed a high percentage of discordant results between the two generations (κ coefficient <0.20). These discrepancies are clinically relevant as PTH levels remain the cornerstone for diagnosis and treatment of the CKD-mineral and bone disorder (CKD-MBD).

Conclusions

The introduction of a new PTH assay generation in clinical practice should be carried out with caution.

Keywords: clinical impact; PTH; second generation; third generation

References

  • 1.

    Sturgeon CM, Sprague S, Almond A, Cavalier E, Fraser WD, Algeciras-Schimnich A, et al. IFCC Working Group for PTH. Perspective and priorities for improvement of parathyroid hormone (PTH) measurement – a view from the IFCC Working Group for PTH. Clin Chim Acta 2017;467:42–7.Web of ScienceCrossrefGoogle Scholar

  • 2.

    Hecking M, Kainz A, Bielesz B, Plischke M, Beilhack G, Hörl WH, et al. Clinical evaluation of two novel biointact PTH(1-84) assays in hemodialysis patients. Clin Biochem 2012;45:1645–51.CrossrefWeb of SciencePubMedGoogle Scholar

  • 3.

    Gannagé-Yared MH, Farès C, Ibrahim T, Rahal ZA, Elias M, Chelala D. Comparison between a second and a third generation parathyroid hormone assay in hemodialysis patients. Metabolism 2013;62:1416–22.CrossrefWeb of ScienceGoogle Scholar

  • 4.

    O’Flaherty D, Sankaralingam A, Scully P, Manghat P, Goldsmith D, Hampson G. The relationship between intact PTH and biointact PTH (1-84) with bone and mineral metabolism in pre-dialysis chronic kidney disease (CKD). Clin Biochem 2013;46:1405–9.CrossrefPubMedWeb of ScienceGoogle Scholar

  • 5.

    Tan K, Ong L, Sethi SK, Saw S. Comparison of the Elecsys PTH(1-84) assay with four contemporary second generation intact PTH assays and association with other biomarkers in chronic kidney disease patients. Clin Biochem 2013;46:781–6.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 6.

    Cavalier E, Betea D, Schleck ML, Gadisseur R, Vroonen L, Delanaye P, et al. The third/second generation PTH assay ratio as a marker for parathyroid carcinoma: evaluation using an automated platform. J Clin Endocrinol Metab 2014;99:E453–7.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 7.

    Cavalier E, Delanaye P, Lukas P, Carlisi A, Gadisseur R, Souberbielle JC. Standardization of DiaSorin and Roche automated third generation PTH assays with an International Standard: impact on clinical populations. Clin Chem Lab Med 2014;52:1137–41.Web of SciencePubMedGoogle Scholar

  • 8.

    Bonanséa TC, Ohe MN, Brandão C, Ferrer CF, Santos LM, Lazaretti-Castro M, et al. Experience with a third-generation parathyroid hormone assay (BIO-PTH) in the diagnosis of primary hyperparathyroidism in a Brazilian population. Arch Endocrinol Metab 2016;60:420–5.CrossrefWeb of ScienceGoogle Scholar

  • 9.

    Einbinder Y, Benchetrit S, Golan E, Zitman-Gal T. Comparison of intact PTH and bio-intact PTH assays among non-dialysis dependent chronic kidney disease patients. Ann Lab Med 2017;37:381–7.CrossrefPubMedWeb of ScienceGoogle Scholar

  • 10.

    Cavalier E, Salsé M, Dupuy AM, Bargnoux AS, Watar F, Souberbielle JC, et al. Establishment of reference values in a healthy population and interpretation of serum PTH concentrations in hemodialyzed patients according to the KDIGO Guidelines using the Lumipulse® G whole PTH (3rd generation) assay. Clin Biochem 2018;54:119–22.CrossrefWeb of ScienceGoogle Scholar

  • 11.

    Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res 1999;8:135–60.PubMedCrossrefGoogle Scholar

  • 12.

    London G, Coyne D, Hruska K, Malluche HH, Martin KJ. The new kidney disease: improving global outcomes (KDIGO) guidelines – expert clinical focus on bone and vascular calcification. Clin Nephrol 2010;74:423–32.Web of ScienceGoogle Scholar

  • 13.

    Moe SM, Drüeke TB, Block GA, Cannata-Andía JB, Elder GJ, Fukagawa M, et al. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention and treatment of chronic kidney disease mineral and bone disorder (CKD-MBD). Kidney Int 2009;76:S1–28.Google Scholar

  • 14.

    Guggenmoos-Holzman I. The meaning of kappa: probabilistic concepts of reliability and validity revisited. J Clin Epidemiol 1996;49:775–82.CrossrefPubMedGoogle Scholar

  • 15.

    KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney International Supplements 2017;7:1–59.Google Scholar

  • 16.

    Gardham C, Stevens PE, Delaney MP, LeRoux M, Coleman A, Lamb EJ. Variability of parathyroid hormone and other markers of bone mineral metabolism in patients receiving hemodialysis. Clin J Am Soc Nephrol 2010;5:1261–7.CrossrefPubMedWeb of ScienceGoogle Scholar

About the article

Received: 2018-03-20

Accepted: 2018-07-06

Published Online: 2018-09-05

Published in Print: 2018-12-19


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 57, Issue 2, Pages 244–249, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2018-0300.

Export Citation

©2019 Walter de Gruyter GmbH, Berlin/Boston.Get Permission

Comments (0)

Please log in or register to comment.
Log in