The upper reference limit for thyroid peroxidase autoantibodies is method-dependent: A collaborative study with biomedical industries

Renato Tozzoli, Federica D'Aurizio, Anna Ferrari, Roberto Castello, Paolo Metus, Beatrice Caruso, Anna Rosa Perosa, Francesca Sirianni, Elisabetta Stenner, Agostino Steffan, Danilo Villalta

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The determination of the upper reference limit (URL) for thyroid peroxidase autoantibodies (TPOAbs) is a contentious issue, because of the difficulty in defining the reference population. The aim of this study was to establish the URL (eURL) for TPOAbs, according to the National Academy of Clinical Biochemistry (NACB) guidelines and to compare them with those obtained in a female counterpart, by the use of six commercial automated platforms. Methods: 120 healthy males and 120 healthy females with NACB-required characteristics ( 0.05). Conclusions: Despite the analytical harmonization, the wide dispersion of the results and the differences of the eURLs between methods suggest the need of further studies focusing on TPO antigen preparations as the possible source of variability between different assays. In addition, the lack of clinical significant difference between males and females, in terms of TPOAb eURLs, confirms the suitability of the NACB recommendations.

Original languageEnglish
Pages (from-to)61-65
Number of pages5
JournalClinica Chimica Acta
Volume452
DOIs
Publication statusPublished - Jan 15 2016

Keywords

  • Autoimmune thyroid diseases
  • Automation
  • Harmonization
  • Immunoassay
  • Thyroid peroxidase autoantibodies
  • Upper reference limit

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

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