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Licensed Unlicensed Requires Authentication Published by De Gruyter September 5, 2018

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

  • Anne Marie Dupuy , Anne Sophie Bargnoux , Marion Morena , Emilie Lauret , Jean Claude Souberbielle , Etienne Cavalier and Jean Paul Cristol EMAIL logo

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.

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

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. 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.

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Received: 2018-03-20
Accepted: 2018-07-06
Published Online: 2018-09-05
Published in Print: 2018-12-19

©2019 Walter de Gruyter GmbH, Berlin/Boston

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