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Harmonization protocols for TSH immunoassays: a multicenter study in Italy

  • Aldo Clerico EMAIL logo , Andrea Ripoli , Antonio Fortunato , Antonio Alfano , Cinzia Carrozza , Mario Correale , Ruggero Dittadi , Gianluca Gessoni , Marco Migliardi , Sara Rizzardi , Concetta Prontera , Silvia Masotti , Giancarlo Zucchelli , Cristina Guiotto , Palma Aurelia Iacovazzi , Giorgio Iervasi and on behalf of the Italian Section of the European Ligand Assay Society (ELAS)
Published/Copyright: February 28, 2017
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 55 Issue 11

Abstract

Background:

Systematic difference between thyroid-stimulating hormone (TSH) immunoassays may produce misleading interpretation when samples of the same patients are measured with different methods. The study aims were to evaluate whether systematic differences are present among TSH immunoassays, and whether it is possible to obtain a better harmonization among TSH methods using results obtained in external quality assessment (EQA) schemes.

Methods:

Seven Italian clinical laboratories measured TSH in 745 serum samples of healthy subjects and patients with thyroid disorders. These samples were also re-measured by two reference laboratories of the study with the six TSH immunoassays most popular in Italy after 2 months of storage at −80 °C. Moreover, these data were compared to 53,823 TSH measurements, obtained by laboratories participant to 2012–2015 EQA annual cycles in 72 quality control samples (TSH concentrations from about 0.1 mIU/L to 18.0 mIU/L). TSH concentrations were recalibrated using a mathematical approach based on the principal component analysis (PCA).

Results:

Systematic differences were found between the most popular commercially available TSH immunoassays. TSH concentrations measured by the clinical laboratories were very closely correlated to those measured with the same method by reference laboratories after 2 months of storage at −80 °C. After recalibration using the PCA approach the variation of TSH values significantly decreased from a median pre-calibration value of 13.53% (10.79%–16.53%) to 9.63% (6.90%–13.21%) after recalibration.

Conclusions:

Our data suggest that EQA schemes are useful to improve harmonization among TSH immunoassays and also to produce some mathematical formulas, which can be used by clinicians to better compare TSH values measured with different methods.

Keywords: harmonization; immunoassay methods; quality control; quality specification; standardization; thyroid-stimulating hormone (TSH)
Corresponding author and Coordinator: Prof. Aldo Clerico, MD, Laboratory of Cardiovascular Endocrinology and Cell Biology, Department of Laboratory Medicine, Fondazione CNR Toscana G. Monasterio, Scuola Superiore Sant’Anna, Via Trieste 41, 56126 Pisa, Italy

Acknowledgments

All the immunoassay kits used in this study were kindly supported by the manufacturers, namely: Abbott Diagnostics Italia (Rome, Italy), Beckman Coulter S.P.A Italy (Cassina de’ Pecchi, Milan, Italy), Roche Diagnostics Italia (Monza, Milan, Italy), Medical Solution Siemens Healthineers Italia (Milan, Italy), and Tosoh Bioscience Srl (Rivoli, Turin, Italy).

  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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Supplemental Material:

The online version of this article offers supplementary material (DOI: https://doi.org/10.1515/cclm-2016-0899).

Received: 2016-10-7
Accepted: 2017-1-25
Published Online: 2017-2-28
Published in Print: 2017-10-26

©2017 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2016-0899
Keywords for this article
harmonization; immunoassay methods; quality control; quality specification; standardization; thyroid-stimulating hormone (TSH)

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. High-sensitivity assays for cardiac troponins – continued
  4. Reviews
  5. The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications
  6. Vitamin B1 in critically ill patients: needs and challenges
  7. Opinion Papers
  8. Point
  9. High-sensitivity cardiac troponin: do think twice, it’s not all right
  10. Counterpoint
  11. Terminology of cardiac troponin assays and data censoring
  12. Establishing consensus-based, assay-specific 99th percentile upper reference limits to facilitate proper utilization of cardiac troponin measurements
  13. Fast track protocols using highly sensitive troponin assays for ruling out and ruling in non-ST elevation acute coronary syndrome
  14. Genetics and Molecular Diagnostics
  15. Relationship between polymorphisms in the CRP, LEP and LEPR genes and high sensitivity C-reactive protein levels in Spanish children
  16. General Clinical Chemistry and Laboratory Medicine
  17. An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes
  18. Selecting multi-rule quality control procedures based on patient risk
  19. Moving sum of number of positive patient result as a quality control tool
  20. Multidisciplinary training activities for decreasing preanalytical mistakes in samples from primary care
  21. Harmonization protocols for TSH immunoassays: a multicenter study in Italy
  22. Circulating free light chain measurement in the diagnosis, prognostic assessment and evaluation of response of AL amyloidosis: comparison of Freelite and N latex FLC assays
  23. Serum prolactin revisited: parametric reference intervals and cross platform evaluation of polyethylene glycol precipitation-based methods for discrimination between hyperprolactinemia and macroprolactinemia
  24. Temporal and regional variability in the request of vitamin D from general practitioners in Spain
  25. Fibrinogen determination according to Clauss: commutability assessment of International and commercial standards and quality control samples
  26. Reference Values and Biological Variations
  27. S100B maternal blood levels are gestational age- and gender-dependent in healthy pregnancies
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  29. Cancer Diagnostics
  30. Serum complexed and free prostate-specific antigen (PSA) for the diagnosis of the polycystic ovarian syndrome (PCOS)
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