Harmonization protocols for thyroid stimulating hormone (TSH) immunoassays: different approaches based on the consensus mean value

Aldo Clerico; Andrea Ripoli; Gian Carlo Zucchelli; Mario Plebani

doi:10.1515/cclm-2014-0586

Article

Harmonization protocols for thyroid stimulating hormone (TSH) immunoassays: different approaches based on the consensus mean value

Aldo Clerico , Andrea Ripoli , Gian Carlo Zucchelli and Mario Plebani

Published/Copyright: September 20, 2014

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 53 Issue 3

Abstract

The lack of interchangeable laboratory results and consensus in current practices has underpinned greater attention to standardization and harmonization projects. In the area of method standardization and harmonization, there is considerable debate about how best to achieve comparability of measurement for immunoassays, and in particular heterogeneous proteins. The term standardization should be used only when comparable results among measurement procedures are based on calibration traceability to the International System of Units (SI unit) using a reference measurement procedure (RMP). Recently, it has been promoted the harmonization of methods for many immunoassays, and in particular for thyreotropin (TSH), as accepted RMPs are not available. In a recent paper published in this journal, a group of well-recognized authors used a complex statistical approach in order to reduce variability between the results observed with the 14 TSH immunoassay methods tested in their study. Here we provide data demonstrating that data from an external quality assessment (EQA) study allow similar results to those obtained using the reported statistical approach.

Keywords: harmonization; immunoassay methods; quality control; quality specification; standardization; thyroid stimulating hormone (TSH)

Corresponding author: Prof. Aldo Clerico, MD, Laboratory of Cardiovascular Endocrinology and Cell Biology, Department of Laboratory Medicine, Fondazione Toscana G. Monasterio, Scuola Superiore Sant’Anna, Via Trieste 41, 56126 Pisa, Italy, E-mail: clerico@ftgm.it

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Received: 2014-6-2

Accepted: 2014-8-24

Published Online: 2014-9-20

Published in Print: 2015-2-1

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Articles in the same Issue

https://doi.org/10.1515/cclm-2014-0586

Keywords for this article

harmonization; immunoassay methods; quality control; quality specification; standardization; thyroid stimulating hormone (TSH)