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Generation of a Mouse Spontaneous Autoimmune Thyroiditis Model
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The upper reference limit for thyroid peroxidase autoantibodies is method-dependent: A collaborative study with

Renato Tozzoli1, Federica D'Aurizio1, Anna Ferrari2

  • 1Laboratory of Clinical Pathology, Department of Laboratory Medicine, S. Maria degli Angeli Hospital, Pordenone, Italy.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|November 1, 2015
PubMed
Summary

Establishing upper reference limits for thyroid peroxidase autoantibodies (TPOAbs) is challenging. This study found that while differences exist between commercial platforms, TPOAb results are clinically similar between males and females, supporting NACB guidelines.

Keywords:
Autoimmune thyroid diseasesAutomationHarmonizationImmunoassayThyroid peroxidase autoantibodiesUpper reference limit

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Area of Science:

  • Clinical Chemistry
  • Immunology
  • Endocrinology

Background:

  • Determining upper reference limits (URLs) for thyroid peroxidase autoantibodies (TPOAbs) is complex due to challenges in defining appropriate reference populations.
  • Existing methods for TPOAb measurement exhibit variability, impacting diagnostic accuracy and clinical interpretation.

Purpose of the Study:

  • To establish the empirical upper reference limit (eURL) for TPOAbs in healthy individuals according to National Academy of Clinical Biochemistry (NACB) guidelines.
  • To compare TPOAb eURLs between healthy males and females using six different commercial automated immunoassay platforms.
  • To assess the clinical significance of observed differences in TPOAb levels between sexes across various analytical platforms.

Main Methods:

  • Studied 120 healthy males and 120 healthy females meeting strict NACB criteria (age <30, TSH 0.5-2.0 mIU/L, normal thyroid ultrasound, no autoimmune history).
  • Analyzed serum TPOAb concentrations using six distinct automated immunoassay methods: Advia Centaur XP, Maglumi 2000 Plus, Architect ci4100, Cobas e411, Unicel DxI, and Lumipulse G1200.
  • Calculated empirical upper reference limits (eURLs) for TPOAbs for each method and compared male and female results.

Main Results:

  • High dispersion of TPOAb values was observed within each method, with calculated eURLs generally lower than manufacturer-stated values.
  • Statistically significant differences in median TPOAb levels between males and females were found for Cobas e411 and Unicel DxI (p<0.05).
  • Despite statistical differences, the proportion of positive TPOAb results using the counterpart's eURL lacked clinical significance (Chi-square test, p>0.05), indicating no meaningful sex-based disparities.

Conclusions:

  • The wide dispersion of TPOAb results and varying eURLs across methods highlight the need for further investigation into TPO antigen preparations as a source of analytical variability.
  • The lack of clinically significant differences in TPOAb eURLs between males and females supports the suitability and applicability of NACB recommendations for TPOAb reference limit determination.
  • Analytical harmonization efforts are ongoing, but standardization of TPO antigen sources is crucial for improving inter-assay consistency in TPOAb measurements.