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Harmonization protocols for TSH immunoassays: a multicenter study in Italy.

Aldo Clerico1, Andrea Ripoli1, Antonio Fortunato1

  • 1.

Clinical Chemistry and Laboratory Medicine
|March 1, 2017
PubMed
Summary

Systematic differences in thyroid-stimulating hormone (TSH) immunoassays were identified. External quality assessment (EQA) schemes and principal component analysis (PCA) can harmonize TSH measurements for improved clinical interpretation.

Keywords:
harmonizationimmunoassay methodsquality controlquality specificationstandardizationthyroid-stimulating hormone (TSH)

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Area of Science:

  • Clinical Chemistry
  • Endocrinology
  • Laboratory Medicine

Background:

  • Thyroid-stimulating hormone (TSH) immunoassays exhibit systematic differences, potentially leading to misinterpretation of patient results across different measurement methods.
  • Harmonizing TSH assay results is crucial for accurate clinical diagnosis and patient management.

Purpose of the Study:

  • To evaluate systematic differences among common TSH immunoassays.
  • To assess the utility of external quality assessment (EQA) schemes for harmonizing TSH measurement methods.

Main Methods:

  • Seven Italian clinical labs and two reference labs measured TSH in 745 serum samples using six popular immunoassays.
  • Data were compared with 53,823 TSH measurements from 2012-2015 EQA cycles.
  • Principal component analysis (PCA) was employed for TSH value recalibration.

Main Results:

  • Significant systematic differences were confirmed among TSH immunoassays.
  • Recalibration using PCA reduced TSH value variation from a median of 13.53% to 9.63%.
  • TSH measurements by clinical and reference labs showed high correlation after storage.

Conclusions:

  • External quality assessment (EQA) schemes effectively improve harmonization of TSH immunoassays.
  • Mathematical formulas derived from EQA data can aid clinicians in comparing TSH values across different methods.